Valve stents, valve prostheses, and delivery devices

Abstract

The present invention provides a valve stent, a valve prosthesis and a conveying device. The valve stent comprises: a stent body, which is in the shape of a net tube; and a plurality of fixing ears, which are arranged on the stent body and bent toward the inner side of the stent body. The valve prosthesis comprises an artificial valve and the above-mentioned valve stent, and the artificial valve is fixed on the valve stent. The conveying device is used to convey the above-mentioned valve prosthesis. The conveying device comprises: a sheath, an inner tube, a fixing head and a guide tube. The sheath is used to accommodate the valve prosthesis. The fixing head is used to limit the position of the fixing ear of the valve prosthesis relative to the inner tube. The guide tube is used to clamp the fixing ear of the valve prosthesis on the fixing head. The valve stent, valve prosthesis and conveying device in the present invention can improve the loading efficiency of the valve prosthesis.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a valve stent, a valve prosthesis and a conveying device. Background Art

[0002] With the advent of an aging society around the world, aortic valve disease has become one of the common cardiovascular diseases. The incidence rate in my country is 2%-5%, while in Europe and the United States it ranks third after coronary heart disease and hypertension. Every year, tens of thousands of patients benefit from surgical aortic valve replacement, but even in developed countries, there are still a large number of patients with severe aortic valve disease who cannot receive surgical treatment due to advanced disease, advanced age, and multiple complications. The emergence of percutaneous artificial aortic valve products and the continuous improvement of product performance have undoubtedly brought good news to these patients and provided an effective treatment method.

[0003] Aortic valve disease can be caused by congenital defects, the natural aging process, infection or scar formation. Over time, calcification may accumulate around the aortic valve, leading to aortic stenosis and / or valvular insufficiency causing "aortic regurgitation". Patients with aortic valve disease mainly experience symptoms such as angina, syncope and heart failure. The patient's quality of life is severely reduced and survival time is significantly shortened, so effective treatment is necessary.

[0004] In 2002, Cribie et al. first reported the first case of transcatheter aortic valve replacement in humans. Since then, many scholars and doctors at home and abroad have carried out basic and clinical research on transcatheter aortic valve replacement (TAVR) and achieved good clinical results. Studies have shown that this new technology is safe and effective for patients who cannot undergo surgical valve replacement or are at high risk of surgical valve replacement. Compared with surgery, percutaneous aortic valve replacement does not require thoracotomy and extracorporeal circulation support. It is a treatment method with less trauma, fewer complications, faster postoperative recovery, less pain for patients, and is easy to accept. Although most patients who undergo TAVR surgery are high-risk patients, the 30-day survival rate after surgery is higher than 90%, and the hemodynamic indicators of patients after surgery have been significantly improved.

[0005] Percutaneous artificial aortic valve products have been continuously updated and improved. The representative products currently used in clinical practice include the Edwards valve stent system and the CoreValve valve stent system.

[0006] The Edwards-SAPIEN bioprosthesis is made of bovine pericardium, sutured and assembled on a stainless steel (or cobalt-chrome alloy) stent, and uses a balloon-expandable stent to position the valve at the annulus. No delivery sheath is required, and it can be implanted by antegrade, retrograde or transapical approaches. The valves available for clinical use have two specifications, 23mm and 26mm in diameter. Patent application W0200i149462A2 describes an example of this aortic valve. The Edwards-SAPIEN aortic valve system has been subjected to a large number of clinical trials, and very ideal research results have been obtained.

[0007] The CoreValve valve system is another valve stent that has been successfully used in clinical practice. It was first successfully applied to humans in 2005. It is mainly composed of a three-leaflet porcine pericardium artificial valve sutured on a nickel-titanium self-expanding stent. This stent currently has three specifications: 26mm, 29mm and 31mm. An example of this valve system is given in the US patent publication US2011 / 0172765A1. The CoreValve valve stent is made of nickel-titanium memory alloy. The upper part of the stent is used to anchor the ascending aorta above the sinus of Valsalva, and its radial support force is relatively low; the middle part of the stent is sewn with a valve leaflet, and its geometric shape is concave, so that the coronary artery blood flow is not blocked; the lower part of the stent is used to be inserted and fixed at the aortic valve ring, and its radial support force is strong. The latest clinical studies have confirmed that the implantation of the CoreValve valve system not only has a good hemodynamic effect, but also has a 30-day mortality rate of 8%, showing a relatively ideal safety.

[0008] However, the fixing ears of existing valve prostheses are all vertically upward structures. Since the fixing ears are larger than other mesh ends, when implanted in the human body, the fixing ears fit against the ascending aorta wall, and the vertically upward structure has the risk of puncturing the ascending aorta. In addition, the structure with the fixing ears pointing vertically upward is difficult to load, which makes loading time-consuming. In the surgical process where every second counts, time is life, and a difference of just a few seconds may be the distance between life and death. Therefore, from this perspective, the disadvantages of the fixing ears pointing vertically upward are particularly obvious. TAVR surgery often involves valve in valve, and the design of the fixing ears pointing vertically upward is not conducive to the stability of the implanted second valve. Summary of the invention

[0009] The purpose of the present invention is to provide a valve stent, a valve prosthesis and a conveying device to solve the problems that the existing prosthesis is difficult to load and time-consuming to load.

[0010] To solve the above technical problems, the present invention provides a valve stent, comprising: a stent body, which is in the shape of a mesh tube; and at least two fixing ears, each of which is connected to the stent body and bent toward the inside of the stent body.

[0011] Optionally, the fixing ear includes a fixing portion and a connecting rod, one end of the connecting rod is connected to the bracket body, the other end of the connecting rod is connected to the fixing portion, and the end of the fixing portion away from the connecting rod is a free end.

[0012] Optionally, the fixing ear includes a first bending section and a second bending section, the first bending section bends toward the inner side of the bracket body at a greater angle than the second bending section bends toward the inner side of the bracket body, and the first bending section is closer to the bracket body than the second bending section.

[0013] Optionally, the first bending section bends toward the inner side of the bracket body at an angle ranging from 10° to 45°, and the second bending section bends toward the inner side of the bracket body at an angle ranging from 5° to 40°.

[0014] Optionally, the angle at which the second bending section bends toward the inner side of the bracket body ranges from 15° to 30°.

[0015] Optionally, the first bending section includes the connecting rod, and the second bending section includes the fixing portion.

[0016] Optionally, the first bending section includes a portion of the connecting rod, and the second bending section includes the fixing portion and another portion of the connecting rod.

[0017] Optionally, the connecting rod includes a first connecting section and a second connecting section, one end of the first connecting section is connected to the bracket body, the other end of the first connecting section is connected to one end of the second connecting section, the other end of the second connecting section is connected to the fixing portion, the first bending section includes the first connecting section, and the second bending section includes the second connecting section and the fixing portion.

[0018] Optionally, the plurality of fixing ears have the same shape and are evenly arranged along the circumference of the bracket body.

[0019] Optionally, the fixing portion of each fixing ear has a through hole.

[0020] Optionally, the total length of the fixing ears is between 1 mm and 6 mm.

[0021] Optionally, the total length of the fixing ears is between 3 mm and 5 mm.

[0022] Optionally, the fixing ears are manufactured by cutting or weaving.

[0023] The present invention also provides a valve prosthesis, comprising an artificial valve and the above-mentioned valve support, wherein the artificial valve is fixed on the valve support.

[0024] The present invention also provides a delivery device, which is used to deliver the above-mentioned valve prosthesis, and the delivery device comprises: a sheath tube, which is used to accommodate the valve prosthesis; an inner tube, which is arranged in the sheath tube; and a fixing head, which is sleeved on the inner tube and fixedly connected to the inner tube, and is used to limit the position of the fixing ear of the valve prosthesis relative to the inner tube.

[0025] Optionally, a guide tube is further included, which is arranged outside the sheath tube, the inner surface of the guide tube is a cone, the guide tube can be sleeved on the inner tube, and the guide tube is used to clamp the fixing ear of the valve prosthesis on the fixing head.

[0026] Optionally, a plurality of grooves are provided on the outer circumference of the fixing head, and the plurality of grooves are evenly distributed on the outer circumference of the fixing head. The fixing ear includes a fixing part and a connecting rod, and the fixing part is fixedly connected to the connecting rod. The connecting rod is arranged on the bracket body, and each of the grooves is used to accommodate a fixing part of the fixing ear.

[0027] Optionally, the groove has a bottom, and the shape of the bottom of the groove is the same as the shape of the fixing portion.

[0028] Optionally, a boss is provided at the bottom of the groove, and the boss matches the through hole provided on the fixing portion of the fixing ear of the valve prosthesis. The valve stent, valve prosthesis and delivery device provided by the present invention have the following beneficial effects:

[0029] First, in the process of loading the valve prosthesis into the sheath of the delivery device, since the fixing ears are bent toward the inside of the stent body, the difficulty of folding the fixing ears and fixing the fixing ears in the delivery device can be reduced, thereby saving the loading time of the valve stent and improving the loading efficiency of the valve prosthesis.

[0030] Secondly, since the fixing ear includes a first bending segment and a second bending segment, the angle at which the first bending segment bends toward the inner side of the stent body is greater than the angle at which the second bending segment bends toward the inner side of the stent body, and the first bending segment is closer to the stent body than the second bending segment. Therefore, the difficulty of folding the fixing ear and fixing the fixing ear in the delivery device when the valve prosthesis is loaded into the sheath can be further reduced, thereby further saving the loading time of the valve stent and improving the loading efficiency of the valve prosthesis.

[0031] Secondly, by bending the fixing ears toward the inside of the stent body, the risk of the fixing ears piercing the wall of the ascending aorta can be reduced.

[0032] Thirdly, the fixing ears of the valve prosthesis are bent inwardly toward the stent body to limit the freedom of the second valve prosthesis to move along the axial direction of the valve prosthesis under the valve-in-valve condition, thereby effectively reducing the risk of displacement of the valve prosthesis. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 is a front view of a valve prosthesis in one embodiment of the present invention;

[0034] Figure 2 is a top view of a valve prosthesis in one embodiment of the present invention;

[0035] Figure 3 is a front view of a valve stent in one embodiment of the present invention;

[0036] Figure 4 is a partially enlarged schematic diagram of a valve prosthesis in one embodiment of the present invention;

[0037] Figure 5 is a schematic structural diagram of a conveying device in an embodiment of the present invention;

[0038] Figure 6 It is a structural schematic diagram of a fixing ear of a valve prosthesis arranged on a fixing head in one embodiment of the present invention;

[0039] Figure 7 is a partially enlarged schematic diagram of a fixed head in one embodiment of the present invention;

[0040] Figure 8 It is a schematic diagram of the structure of a valve prosthesis in the prior art when loaded;

[0041] Fig. 9 is a schematic structural diagram of a valve prosthesis when loaded in an embodiment of the present invention,

[0042] Fig.10 is a schematic diagram of a valve prosthesis in one embodiment of the present invention after being implanted into the aorta;

[0043] Fig.11 yes Fig.10 A partial enlarged schematic diagram of point A in the schematic diagram after the valve prosthesis is implanted in the aorta;

[0044] Fig.12 It is a schematic diagram of a structure when two valve prostheses are implanted in the aorta in one embodiment of the present invention;

[0045] Fig.13 is another structural schematic diagram of an embodiment of the present invention when two valve prostheses are implanted in the aorta;

[0046] Fig.14 yes Fig.13FIG. 1 is a schematic diagram of the partial structure of two valve prostheses B in a first state when two valve prostheses are implanted in the aorta;

[0047] Fig.15 yes Fig.13 FIG. 1 is a schematic diagram of the partial structure of two valve prostheses B in a second state when two valve prostheses are implanted in the aorta;

[0048] Fig.16 is a front view of a valve prosthesis in another embodiment of the present invention;

[0049] Fig.17 is a partially enlarged schematic diagram of a fixing ear in another embodiment of the present invention;

[0050] Fig.18 is a schematic structural diagram of another embodiment of the present invention when two valve prostheses are implanted in the aorta,

[0051] Fig.19 is a front view of a valve prosthesis in another embodiment of the present invention;

[0052] Fig. 20 is a front view of a valve prosthesis in another embodiment of the present invention;

[0053] Fig.21 is a partially enlarged schematic diagram of a fixing ear of a valve prosthesis in yet another embodiment of the present invention;

[0054] Fig. 22 It is a partially enlarged schematic diagram of a conveying device in another embodiment of the present invention.

[0055] Description of reference numerals:

[0056] 100-valve prosthesis;

[0057] 200-artificial valve; 210-valve leaflet; 220-skirt;

[0058] 300-valve stent;

[0059] 310-stent body; 311-inflow channel structure; 312-transition channel structure; 313-outflow channel; 314-suture ring;

[0060] 320-fixing ear; 320a-first connecting end; 321-fixing portion; 322-connecting rod; 323-through hole; 324-first connecting section; 325-second connecting section;

[0061] 400- conveying device;

[0062] 410-sheath;

[0063] 420-inner tube; 421-first tube body; 422-second tube body;

[0064] 430-fixed head; 431-groove; 432-bottom; 433-boss;

[0065] 440 - guide tube; 441 - inner surface; 442 - first end; 443 - second end;

[0066] First angle δ1; second angle δ2; third angle δ3; first arrow J1; second arrow J2; third arrow J3; D-aorta; W1-first position; W2-second position; P-node; W3-third position; W4-fourth position;

[0067] 500 - first valve prosthesis; 600 - second valve prosthesis. DETAILED DESCRIPTION

[0068] The valve stent, valve prosthesis and delivery device proposed in the present invention are further described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be noted that the accompanying drawings are in a very simplified form and use non-precise proportions, which are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention. In the following embodiments, the angle at which any one of the fixing ear, the fixing portion, the connecting rod, the first bending section and the second bending section is bent toward the inner side of the stent body refers to the angle between it and the central axis of the valve stent.

[0069] Embodiment 1

[0070] This embodiment provides a valve prosthesis. Figure 1 and Figure 2 , Figure 1 is a front view of a valve prosthesis in one embodiment of the present invention, Figure 2 1 is a top view of a valve prosthesis in an embodiment of the present invention, wherein the valve prosthesis 100 comprises an artificial valve 200 and a valve support. The artificial valve 200 is fixed on the valve support.

[0071] The artificial valve 200 includes a leaflet 210 and a skirt 220. The leaflet 210 and the skirt 220 are fixed to the valve support by suturing. The skirt 220 is used to prevent paravalvular leakage. In this embodiment, the artificial valve 200 can be a tricuspid valve.

[0072] refer to Figure 3 , Figure 3: is a front view of a valve stent in an embodiment of the present invention, wherein the valve stent 300 includes a stent body 310 and two fixing ears 320. The stent body 310 is in the shape of a net tube. The two fixing ears 320 are arranged on the stent body 310, and the two fixing ears 320 are bent toward the inner side of the stent body 310. Specifically, the fixing ear 320 has a first connecting end 320a, and the first connecting end 320a is connected to the stent body 310. From the first connecting portion 320a, the fixing ear 320 extends in a direction close to the central axis of the stent body 310.

[0073] refer to Figure 3 The support body 310 includes an inflow channel structure 311, a transition channel structure 312 and an outflow channel structure 313 which are connected in sequence.

[0074] Specifically, the maximum outer diameter of the outflow channel structure 313 of the stent body 310 is the largest, the maximum outer diameter of the transition channel structure 312 is the smallest, and the outer diameter of the inflow channel structure 311 gradually decreases from one end away from the transition channel structure 312 to the other end close to the transition channel structure 312. The mesh of the outflow channel structure 313 is sparse and wide, while the mesh of the inflow channel structure 311 is denser and narrower. The number of meshes in the outflow channel structure 313 is less than the number of meshes in the transition channel structure 312 and the inflow channel structure 311. Those skilled in the art should understand that the outer diameters of the inflow channel structure 311, the transition channel structure 312 and the outflow channel structure 313 in this embodiment can be changed in other ways. For example, the maximum outer diameter of the inflow channel structure 311 can be located in the middle section of the inflow channel structure 311. Those skilled in the art should also understand that the grids of the inlet channel structure 311, the transition channel structure 312 and the outflow channel structure 313 described in this embodiment may also be changed in other ways, for example, the sizes of the grids of the inlet channel structure 311, the transition channel structure 312 and the outflow channel structure 313 may be equal or unequal.

[0075] The transition channel structure 312 is provided with a plurality of sewing rings 314, and the leaflets 210 are sewn at the positions of the stent sewing rings 314. The sewing rings 314 are preferably evenly distributed along the axial direction of the valve stent 300. Preferably, three sewing rings 314 are provided on the transition channel structure 312.

[0076] The inflow channel structure 311 is sutured with a skirt 220. The material of the skirt 220 can be selected from medical materials with sealing effect, and the suture method adopts the existing suture technology.

[0077] refer to Figure 3, one end of the outflow channel structure 313 away from the transition channel structure 312 is bent toward the inner side of the outflow channel structure 313. Specifically, the outflow channel structure 313 extends from the connection with the transition channel structure 312 in a direction away from the central axis of the stent body 310, and then extends in a direction close to the central axis of the stent body 310 at the maximum outer diameter of the outflow channel structure 313.

[0078] In this embodiment, the shape of the mold can be used to constrain the fixing ear 320 so that the fixing ear 320 is tilted toward the inside of the stent body 310. The angle at which the fixing ear 320 bends toward the inside of the stent body 310 is the angle between the fixing ear 320 and the central axis of the valve stent 300. For example, Figure 3 , the angle between the fixing ear 320 and the central axis of the valve stent 300 is a first angle δ1. The angle at which the fixing ear 320 bends toward the inner side of the stent body 310 is 10° to 45°. Experimental studies have shown that when the angle at which the fixing ear 320 bends toward the inner side of the stent body 310 exceeds 45°, the loading of the valve prosthesis 100 will become very difficult, and when the angle at which the fixing ear 320 bends toward the inner side of the stent body 310 is less than 10°, the bending of the fixing ear 320 toward the inner side of the stent body 310 will not have a good effect. Therefore, in this embodiment, the angle at which the multiple fixing ears 320 bend toward the inner side of the stent body 310 is preferably between 10° and 45°.

[0079] Specifically, refer to Figures 1 to 3 , two left-right symmetrical fixing ears 320 are provided at one end of the outflow channel structure 313 away from the transition channel structure 312. In other embodiments, the number of the fixing ears 320 may be three, four or five. The number of the fixing ears 320 is preferably two to four. The plurality of fixing ears 320 are preferably uniformly arranged along the circumference of the support body 310. For example, when the number of the fixing ears 320 is two, the interval between the two fixing ears 320 is 180°, and when the number of the fixing ears 320 is three, the interval between two adjacent fixing ears 320 is 120°. Of course, in other embodiments, the plurality of fixing ears 320 may also be non-uniformly arranged along the circumference of the support body 310. The shapes of the plurality of fixing ears 320 are preferably the same.

[0080] Specifically, refer to Figure 4 , Figure 4It is a partial enlarged schematic diagram of a valve prosthesis in an embodiment of the present invention. In this embodiment, the fixing ear 320 includes a fixing portion 321 and a connecting rod 322. One end of the connecting rod 322 is connected to the stent body 310, and the other end of the connecting rod 322 is connected to the fixing portion 321. The first connecting end 320a is the end of the connecting rod 322 connected to the stent body 310. The end of the fixing portion 321 away from the connecting rod 322 is the free end of the fixing ear 320. The fixing portion 321 is preferably flat. Specifically, refer to Figure 1 , Figure 2 , Figure 3 and Figure 4 The first connecting portion 320a is preferably connected to the top of the grid on the outflow channel structure 313, the periphery of the fixing portion 321 adopts a smooth rounded transition, and the connecting rod 322 is rod-shaped, and the overall width is smaller than that of the fixing portion 321.

[0081] The total length of the fixing ear 320 is preferably between 1 mm and 6 mm. Further, the total length of the fixing ear 320 is between 3 mm and 5 mm. The fixing ear 320 within this length range is conducive to the realization of the bending angle of the fixing ear 320 to achieve a better loading effect.

[0082] In this embodiment, the fixing ears 320 and the bracket body 310 are manufactured in one piece. For example, the net-shaped bracket body 310 and the fixing ears 320 can be cut out from a shape memory alloy (generally a nickel-titanium alloy) tube, and then shaped by a mold. Of course, in other embodiments, the fixing ears 320 and the bracket body 310 can also be manufactured separately, and then the bracket body 310 and the fixing ears 320 are fixedly connected by welding or suturing.

[0083] The valve prosthesis 100 in this embodiment can be implanted into a human body through a delivery device. Before the implantation operation, the valve prosthesis 100 is usually loaded into the delivery device. Figure 5 , Figure 54 is a schematic diagram of the structure of a delivery device in an embodiment of the present invention, wherein the delivery device 400 comprises a sheath tube 410, an inner tube 420, a fixing head 430 and a guide tube 440. The sheath tube 410 is used to accommodate the valve prosthesis 100. The inner tube 420 is arranged inside the sheath tube 410. The fixing head 430 is sleeved on the inner tube 420, and the fixing head 430 is fixedly connected to the inner tube 420. The fixing head 430 is used to limit the position of the fixing ear 320 of the valve prosthesis 100 relative to the inner tube 420. The fixing head 430 and the inner tube 420 can move along the sheath tube 410. The guide tube 440 is arranged outside the sheath tube 410, and the guide tube 440 is used to clamp the fixing ear 320 of the valve prosthesis 100 on the fixing head 430.

[0084] refer to Figure 5 and Figure 6 , Figure 6 4 is a schematic diagram of a structure in which a fixing ear of a valve prosthesis is arranged on a fixing head in an embodiment of the present invention, wherein the inner tube 420 is composed of a first tube body 421 and a second tube body 422. Figure 5 and Figure 6 In the embodiment, the fixing head 430 is installed on the first tube body 421 .

[0085] The fixing head 430 is preferably located at the middle position of the inner tube 420, that is, at the place where the first tube body 421 and the second tube body 422 are connected. Figure 5 and Figure 6 In this embodiment, the outer diameter of the first tube body 421 is preferably smaller than the outer diameter of the second tube body 422. The material of the first tube body 421 is preferably softer than that of the second tube body 422.

[0086] At least two grooves 431 are formed on the outer circumference of the fixing head 430 , and the plurality of grooves 431 are preferably evenly distributed on the outer circumference of the fixing head 430 .

[0087] refer to Figure 7 , Figure 7 : is a partial enlarged schematic diagram of a fixing head in an embodiment of the present invention, each of the grooves 431 can accommodate a fixing portion 321 of a fixing ear 320. The groove 431 has a bottom 432, and the shape of the bottom 432 of the groove 431 matches the shape of the fixing portion 321. For example, the bottom 432 of the groove 431 is a first curved surface, and the inner side of the fixing portion 321 of the fixing ear 320 is a second curved surface, and the first curved surface and the second curved surface can at least partially overlap, so that the first curved surface and the second curved surface can be fitted.

[0088] Preferably, the depth of the groove 431 is greater than the thickness of the fixing ear 320 by 0 to 0.4 mm.

[0089] refer to Figure 6 and Figure 7 The outer contour of the end of the fixing head 430 away from the second tube body 422 is larger than the outer diameter of the first tube body 421, thereby forming a convex surface protruding from the outer surface of the first tube body 421. When the valve prosthesis 100 is loaded onto the fixing head 430, the end of the outflow channel structure 313 away from the transition channel structure 312 can be abutted against the convex surface, thereby preventing the valve prosthesis 100 from moving relative to the inner tube 420, so as to facilitate the valve prosthesis 100 to be loaded into the sheath tube 410.

[0090] like Figure 5 and Figure 6 As shown, the inner surface 441 of the guide tube 440 is a conical surface. The guide tube 440 has a first end 442 and a second end 443. The first end 442 is located at the large diameter end of the inner surface 441 of the guide tube 440, and the second end 443 is located at the small diameter end of the inner surface 441 of the guide tube 440. When the guide tube 440 clamps the fixing ear 320 of the valve prosthesis 100 on the fixing head 430, the guide tube 440 is sleeved on the inner tube 420, and the fixing ear 320 of the valve prosthesis 100 passes through the small diameter end of the inner surface 441 of the guide tube 440, and is retracted under the action of the inner surface 441 of the guide tube 440.

[0091] In this embodiment, the process of loading the valve prosthesis 100 into the sheath tube 410 of the delivery device 400 is as follows:

[0092] First, the valve prosthesis 100 is placed in ice water, and the guide tube 440 is sleeved onto the valve prosthesis 100 , so that the fixing ears 320 of the valve prosthesis 100 are retracted under the action of the guide tube 440 .

[0093] Next, the inner tube 420 is inserted into the valve prosthesis 100 and the guide tube 440 from the side of the valve prosthesis 100 having the fixing ear 320 , so that the valve prosthesis 100 and the guide tube 440 are sleeved on the inner tube 420 .

[0094] Next, adjust the positions of the valve prosthesis 100 and the guide tube 440 so that the fixing ears 320 of the valve prosthesis 100 correspond to the positions of the grooves 431 on the fixing head 430. Then, move the guide tube 440 toward the sheath tube 410 to further close the fixing ears 320. The moving direction of the guide tube 440 can be referred to as Figure 6The fixing ear 320 is moved in the direction indicated by the first arrow J1 in the figure until the fixing ear 320 is clamped in the groove 431 of the fixing head 430, and at this time, the fixing ear 320 of the valve prosthesis 100 just contacts the bottom 432 of the groove 431 of the fixing head 430. In this process, the end of the outflow channel structure 313 of the valve prosthesis 100 away from the transition channel structure 312 can be abutted against the convex surface of the fixing head 430, and then the position of the fixing ear 320 can be adjusted by rotating the guide tube 440 and the valve prosthesis 100.

[0095] Afterwards, the sheath tube 410 is moved toward the side close to the guide tube 440, and the valve prosthesis 100 is gradually received into the sheath tube 410. The moving direction of the sheath tube 410 can refer to the Figure 6 The direction is indicated by the first arrow J1.

[0096] During the process of loading the valve prosthesis 100 into the sheath 410, since the fixing ears 320 are bent toward the inside of the stent body 310, the difficulty of folding the fixing ears 320 and fixing the fixing ears 320 in the delivery device 400 can be reduced, thereby saving the loading time of the valve stent 300 and improving the loading efficiency of the valve stent 300.

[0097] Compared with the prior art valve prosthesis 100 in which the fixing ears 320 are all vertically upward structures, the loading difficulty of the valve prosthesis 100 in this embodiment can be greatly reduced. Figure 8 and Fig. 9 , Figure 8 is a schematic diagram of the structure of a valve prosthesis in the prior art when loaded, Fig. 9 It is a structural diagram of the valve prosthesis during loading in an embodiment of the present invention. When the valve prosthesis is compressed to the same position, the two fixing ears of the valve prosthesis in the prior art extend along the axial direction of the valve prosthesis, and the fixing ears cannot enter the sheath. The valve prosthesis must be further compressed to make the fixing ears closer to the groove in the fixing head. In this process, the fixing ears move from the first position W1 to the second position W2, and the inner side of the fixing ears and the bottom of the groove are completely fitted. At this time, the entire valve prosthesis is compressed to a size less than or equal to the inner diameter of the sheath, which is very difficult to achieve during actual loading. In this embodiment, the fixing ears are already close to the groove in the fixing head, or can be fitted with the groove in the fixing head. Therefore, in this embodiment, the loading difficulty of the valve prosthesis 100 can be greatly reduced, and the loading efficiency can be greatly improved.

[0098] In this embodiment, the valve prosthesis 100 has a release state and a compression state. In the release state, the valve prosthesis 100 opens into a petal-like shape. During the implantation process, the valve prosthesis 100 is compressed into a sheath tube 410 with a very small inner diameter by a delivery device 400, and then implanted through an arterial or apical approach. When the valve prosthesis 100 reaches the aortic root position, the valve prosthesis 100 is released, at which time the valve prosthesis 100 opens and expands, the prosthetic leaflets 210 are stretched, and the valve prosthesis 100 starts to work.

[0099] Specifically, refer to Fig.10 , Fig.10 4 is a schematic diagram of a valve prosthesis in an embodiment of the present invention after being implanted in the aorta. During the implantation process, after the valve prosthesis 100 is loaded into the sheath tube 410, the valve prosthesis 100 can reach the root of the aorta D, i.e., the third position W3, through the delivery device 400. When the position of the valve prosthesis 100 is determined to be appropriate, the valve prosthesis 100 can be released. As the release process of the valve prosthesis 100 proceeds, the valve prosthesis 100 gradually opens. After being fully released, the outflow tract structure 313 of the valve prosthesis 100 will be located at the position of the ascending aorta D, i.e., the fourth position W4, which can be referred to as Fig.10 .

[0100] When the valve prosthesis 100 is implanted at the root of the aorta D, the outflow tract structure 313 of the valve prosthesis 100 is located in the ascending aorta D. Since the aorta D has great elasticity, the outflow tract structure 313 with a larger maximum outer diameter in the valve prosthesis 100 will stretch the aorta D. Since the volume of the fixing ear 320 of the valve prosthesis 100 is larger and longer than other mesh tips of the valve prosthesis 100, if the fixing ear is vertically upward, that is, the fixing ear extends in a direction parallel to the central axis of the stent body, then the fixing ear is very likely to puncture or injure the wall of the ascending aorta D, causing serious complications. Therefore, by bending the fixing ear 320 toward the inside of the stent body 310, the risk of the fixing ear 320 puncturing the wall of the ascending aorta D can be reduced. Fig.11 , Fig.11 yes Fig.10 In the partially enlarged schematic diagram of point A in the schematic diagram after the valve prosthesis is implanted in the aorta, there is a certain distance between the fixing ear 320 bent toward the inside of the stent body 310 and the wall of the ascending aorta D, which can effectively avoid damage to the wall of the aorta D by the fixing ear 320.

[0101] After the valve prosthesis 100 is implanted in the aorta D, the release position is often not ideal. If the position of the valve prosthesis 100 after implantation in the aorta D is not ideal, it is easy to cause a large regurgitation of the aorta D, and a valve prosthesis 100 must be implanted again, that is, a valve-in-valve is formed. In the valve-in-valve, the second implanted valve prosthesis 100 is mainly positioned by the support force provided by its outflow tract structure 313.

[0102] refer to Fig.12 , Fig.13 , Fig.14 and Fig.15 , Fig.12 FIG. 1 is a schematic diagram of a structure of an embodiment of the present invention when two valve prostheses are implanted in the aorta, wherein one valve prosthesis has been implanted and the other is in the process of being implanted. Fig.13 It is another structural schematic diagram of implanting two valve prostheses in the aorta in one embodiment of the present invention, wherein both valve prostheses have been implanted. Fig.14 yes Figure 3 FIG. 1 is a schematic diagram of the partial structure of two valve prostheses B in a first state when two valve prostheses are implanted in the aorta. Fig.15 yes Figure 3 1 is a partial structural diagram of two valve prostheses B in the second state when two valve prostheses are implanted in the aorta. The overall structure of the valve prostheses 500 and 600 in this embodiment can be any form of the valve prosthesis 100 in the above embodiment, which will not be repeated here.

[0103] The second valve prosthesis 600 is located in the first valve prosthesis 500, and the second valve prosthesis 600 is implanted in the aorta D after the first valve prosthesis 500. When the second valve prosthesis 600 is delivered to the root of the aorta D, refer to Fig.12 , the second valve prosthesis 600 is not released. According to the image information of the two valve prostheses displayed by the developing instrument, the position of the second valve prosthesis 600 relative to the first valve prosthesis 500 can be adjusted so that the position of the second valve prosthesis 600 relative to the aorta D and the first valve prosthesis 500 is moderate. At the same time, the sheath tube 410 can be rotated so that the fixing ears 320 of the second valve prosthesis 600 and the fixing ears 320 of the first valve prosthesis 500 are staggered by a certain angle, preferably 30°. Subsequently, the second valve prosthesis 600 is released.

[0104] Since the fixing ears 320 are bent toward the inner side of the stent body 310, after the second valve prosthesis 600 is completely released, the relative positions of the two valve prostheses 100 are in at least the following two states. Fig.14At this time, the second valve prosthesis 600 is implanted at a high position, and the relative positions of the two valve prostheses 100 are in the first state, that is, the fixing ear 320 of the first valve prosthesis 500 is embedded in the lower side of a node P of the second valve prosthesis 600, that is, the fixing ear 320 of the first valve prosthesis 500 is embedded in the side of a node P of the second valve prosthesis 600 close to the inflow channel structure 311. In addition, since the fixing ear 320 of the first valve prosthesis 500 is bent toward the inner side of the stent body 310, it can limit the second valve prosthesis 600 from moving away from the aorta D. The direction of the second valve prosthesis 600 moving away from the aorta D can be referred to Fig.14 The second arrow J2 in .

[0105] refer to Fig.15 At this time, the second valve prosthesis 600 is implanted at a low position, and the relative positions of the two valve prostheses 100 are in the second state, that is, the fixing ear 320 of the first valve prosthesis 500 is embedded in the upper side of a node P of the second valve prosthesis 600, that is, the fixing ear 320 of the first valve prosthesis 500 is embedded in the side of a node P of the second valve prosthesis 600 away from the inflow channel structure 311. In addition, since the fixing ear 320 of the first valve prosthesis 500 is bent toward the inner side of the stent body 310, it can limit the second valve prosthesis 600 from moving in the direction close to the aorta D. The direction of the second valve prosthesis 600 moving in the direction close to the aorta D can be referred to Fig.15 The third arrow J3 in .

[0106] As can be seen from the above, the fixing ears 320 of the valve prosthesis 100 are bent inwardly toward the stent body 310 to limit the freedom of the second valve prosthesis 600 to move axially along the valve prosthesis 100 under the valve-in-valve condition, which can effectively reduce the risk of displacement of the valve prosthesis 100.

[0107] Embodiment 2

[0108] Based on the above embodiments, the applicant also proposed a valve prosthesis, which is substantially the same as the valve prosthesis in the above embodiments, except for the shape and structure of the fixing ears. The similarities will not be described here, and the structure of the fixing ears will be mainly introduced.

[0109] refer to Fig.16 and Fig.17 , Fig.16 is a front view of a valve prosthesis in another embodiment of the present invention, Fig.17 It is a partially enlarged schematic diagram of a fixing ear in another embodiment of the present invention. The fixing ear in this embodiment also includes a connecting rod and a fixing portion, but the difference is that, in this embodiment, the angle at which the fixing ear is bent toward the inner side of the bracket body may be different in each section.

[0110] In this embodiment, the connecting rod 322 may also be an arc-shaped rod, and the angle at which the fixing portion 321 extends in the direction close to the central axis of the bracket body 310 is smaller than the angle between the line connecting the two ends of the connecting rod 322 and the central axis of the bracket body 310, that is, the angle at which the fixing portion 321 bends toward the inside of the bracket body 310 is smaller than the angle at which the connecting rod 322 bends toward the inside of the bracket body 310. Fig.17 As shown, the angle at which the fixing portion 321 is bent toward the inner side of the bracket body 310 is a second angle δ2, and the angle at which the connecting rod 322 is bent toward the inner side of the bracket body 310 is a third angle δ3.

[0111] If all parts of the fixing ears 320 are bent at the same angle toward the inside of the stent body 310, the valve prosthesis is compressed during loading, and only the end of the fixing portion 321 of the fixing ear 320 fits with the groove 431 of the fixing head 430. Those skilled in the art should understand that, at this time, for the fixing ear, the contact surface between the fixing portion 321 of a single fixing ear 320 and the groove 431 is small. Therefore, when the valve prosthesis is further loaded into the sheath 410, the fixing portion 321 of the fixing ear 320 is easy to slip out of the groove 431. When the angle at which the fixing portion 321 of the fixing ear 320 extends along the direction close to the central axis of the stent body 310 is smaller than the angle between the line between the two ends of the connecting rod 322 and the direction of the central axis of the stent body 310, that is, the angle at which the fixing portion 321 bends toward the inner side of the stent body 310 is smaller than the angle between the line between the two ends of the connecting rod 322 and the direction of the central axis of the stent body 310, the fitting surface between the fixing portion 321 of the fixing ear 320 and the groove 431 can be increased, thereby preventing the fixing portion 321 of the fixing ear 320 from slipping out of the groove 431 when the valve prosthesis is loaded into the sheath, thereby further reducing the loading difficulty and improving the loading efficiency.

[0112] In addition, if the connecting rod 322 and the fixing portion 321 of the fixing ear 320 are bent toward the inside of the stent body 310, the minimum inner diameter of the fixing ear 320 will become smaller after the first valve prosthesis 500 is released. Therefore, when the second valve prosthesis 600 is implanted, the fixing ear 320 is likely to interfere with the second valve prosthesis 600 or the delivery device for delivering the second valve prosthesis 600, thereby easily causing the first valve prosthesis 500 to shift during the implantation of the second valve prosthesis 600, resulting in complications such as conduction block and reflux. Therefore, referring to Fig.18 , Fig.18It is a structural schematic diagram of another embodiment of the present invention when two valve prostheses are implanted in the aorta. If the valve prosthesis in this embodiment is used, since the angle at which the fixing portion 321 bends toward the inside of the stent body 310 is smaller than the angle between the line between the two ends of the connecting rod 322 and the direction of the central axis of the stent body 310, it is possible to avoid the two fixing ears 320 being too close to one end away from the inflow duct of the valve prosthesis, thereby avoiding interference between the fixing ears and the second valve prosthesis 600 or the delivery device for delivering the second valve prosthesis 600.

[0113] Of course, in other embodiments, the angle at which the fixing portion 321 is bent toward the inner side of the bracket body 310 may be greater than or equal to the angle at which the connecting rod 322 is bent toward the inner side of the bracket body 310 .

[0114] In this embodiment, the connecting rod includes a first connecting section 324 and a second connecting section 325. One end of the first connecting section 324 is connected to the bracket body 310, and the other end of the first connecting section 324 is connected to one end of the second connecting section 325. The end of the first connecting section 324 connected to the bracket body 310 is the first connecting end 320a. The other end of the second connecting section 325 is connected to the fixing portion.

[0115] The first connecting segment 324 forms a first bending segment of the fixing ear 320, and the second connecting segment 325 forms a second bending segment of the fixing ear 320. The first connecting segment 324 and the second connecting segment 325 may be bent at the same or different angles toward the inside of the bracket body 310. For example, the angle at which the second connecting segment 325 is bent toward the inside of the bracket body 310 is greater than the angle at which the first connecting segment 324 is bent toward the inside of the bracket body 310, or the angle at which the second connecting segment 325 is bent toward the inside of the bracket body 310 is less than the angle at which the first connecting segment 324 is bent toward the inside of the bracket body 310.

[0116] like Fig.16 and Fig.17As shown, preferably, the second connecting segment 325 and the fixing portion 321 jointly form a second bending segment of the fixing ear, that is, the angle at which the first connecting segment 324 bends toward the inner side of the bracket body 310 is greater than the angle at which the second connecting segment 325 bends toward the inner side of the bracket body 310, and the angle at which the second connecting segment 325 bends toward the inner side of the bracket body 310 is equal to the angle at which the fixing portion 321 bends toward the inner side of the bracket body 310, that is, the fixing ear 320 is bent at the connection between the first connecting segment 324 and the second connecting segment 325, and the second connecting segment 325 and the fixing portion 321 are bent at a predetermined angle in a direction away from the central axis of the bracket body 310.

[0117] Embodiment 3

[0118] This embodiment provides a valve prosthesis. Fig.19 , Fig.19 It is a front view of a valve prosthesis in another embodiment of the present invention. The main difference between the valve prosthesis 100 in this embodiment and the valve prosthesis 100 in the first embodiment is that in this embodiment, the multiple fixing ears 320 of the valve prosthesis 100 can be made by weaving.

[0119] Preferably, in this embodiment, the plurality of fixing ears 320 may be made by multi-layer weaving.

[0120] In the present embodiment, since the plurality of fixing ears 320 are made by weaving, they are softer than the fixing ears 320 made by other methods, such as softer than the fixing ears 320 made by cutting. When the fixing ears 320 come into contact with the wall of the aorta D, the fixing ears 320 can be easily squeezed, so that the fixing ears 320 bend toward the inside of the stent body 310 without damaging the wall of the aorta D, thereby reducing the risk of the fixing ears 320 puncturing the wall of the aorta D.

[0121] In addition, since the thickness of the fixing ears 320 made by multi-layer weaving is greater than that of the fixing ears 320 made by cutting, it is convenient to fix the fixing ears 320 to the delivery device 400, thereby facilitating the loading of the valve prosthesis 100 into the delivery device 400. In addition, since the multi-layer woven valve prosthesis 100 is relatively soft, it is possible to reduce the difficulty of folding the fixing ears 320 and fixing the fixing ears 320 in the delivery device 400 when the valve prosthesis 100 is loaded into the sheath tube 410, thereby saving the loading time of the valve stent 300, and improving the loading efficiency of the valve stent 300.

[0122] refer to Fig.19In this embodiment, the stent body 310 and the fixing ears 320 of the valve prosthesis 100 are both made by weaving. The fixing ears 320 can be integrally woven with the stent body 310, or can be woven separately and then welded to the stent body 310. In other embodiments, the stent body 310 of the valve prosthesis 100 can be formed by other methods.

[0123] In this embodiment, the plurality of fixing ears 320 can be bent toward the inner side of the bracket body 310 by means of mold shaping.

[0124] like Fig.19 As shown, the fixing ear 320 is L-shaped, that is, the fixing ear 320 first extends inwardly of the bracket body 310 along the radial direction of the bracket body 310 , and then extends in a direction away from the outflow channel structure 313 along the axial direction of the bracket body 310 .

[0125] The difference between this embodiment and the first embodiment is that, in this embodiment, the plurality of fixing ears 320 may extend in a direction parallel to the axial direction of the bracket body 310 and away from the outflow channel structure 313 .

[0126] Embodiment 4

[0127] This embodiment provides a valve prosthesis. The main difference between the valve prosthesis in this embodiment and the valve prosthesis in the first embodiment is that in this embodiment, the multiple fixing ears of the valve prosthesis can be made by cutting, while the stent body is made by weaving.

[0128] Embodiment 5

[0129] This embodiment provides a valve prosthesis. Fig. 20 and Fig.21 , Fig. 20 is a front view of a valve prosthesis in another embodiment of the present invention, Fig.21 It is a partially enlarged schematic diagram of the fixing ears of the valve prosthesis in another embodiment of the present invention. The main difference between the valve prosthesis in this embodiment and the valve prosthesis in the first embodiment is that in this embodiment, the multiple fixing ears 320 of the valve prosthesis 100 can be made by weaving.

[0130] refer to Fig. 20 and Fig.21 In this embodiment, the fixing ear 320 has a through hole 323. The through hole 323 is preferably located at the center of the fixing portion 321 of the fixing ear 320. The thickness of the fixing ear 320 is preferably greater than the thickness of the bracket body 310.

[0131] In this embodiment, reference Fig. 22 , Fig. 224 is a partial enlarged schematic diagram of a delivery device in another embodiment of the present invention, in which a boss 433 may be provided at the bottom 432 of the groove 431 of the fixing head 430 of the delivery device 400. The boss 433 preferably matches the through hole 323 of the fixing ear 320. When the valve prosthesis 100 is loaded into the delivery device 400, when the valve prosthesis 100 is slightly retracted, that is, when the fixing ear 320 is retracted, the inner hole of the fixing ear 320 can be hung on the boss 433 of the bottom 432 of the groove 431 of the fixing head 430, so that the fixing ear 320 of the valve prosthesis 100 is slightly compressed so that the fixing ear 320 can contact the bottom 432 of the groove 431 of the fixing head 430, thereby facilitating the loading of the fixing ear 320 into the sheath tube 410.

[0132] A valve stent, a valve prosthesis and a delivery device provided by the present invention can achieve the following effects by bending the fixing ears toward the inside of the stent body:

[0133] First, in the process of loading the valve prosthesis into the sheath of the delivery device, since the fixing ears are bent toward the inside of the stent body, the difficulty of folding the fixing ears and fixing the fixing ears in the delivery device can be reduced, thereby saving the loading time of the valve stent and improving the loading efficiency of the valve prosthesis.

[0134] Secondly, since the bending angle of the multiple fixing ears toward the inner side of the stent body is greater than the bending angle of the end of the outflow duct structure away from the transition duct structure toward the inner side of the outflow duct structure, the difficulty of folding the fixing ears and fixing the fixing ears in the delivery device when the valve prosthesis is loaded into the sheath can be further reduced, thereby further saving the loading time of the valve stent and improving the loading efficiency of the valve prosthesis.

[0135] Secondly, by bending the fixing ears toward the inside of the stent body, the risk of the fixing ears piercing the wall of the ascending aorta can be reduced.

[0136] Thirdly, the fixing ears of the valve prosthesis are bent inwardly toward the stent body to limit the freedom of the second valve prosthesis to move along the axial direction of the valve prosthesis under the valve-in-valve condition, thereby effectively reducing the risk of displacement of the valve prosthesis.

[0137] The above description is only a description of the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention. Any changes or modifications made by a person skilled in the art in the field of the present invention based on the above disclosure shall fall within the scope of protection of the claims.

Claims

1. A valve stent, characterized in that: include: A stent body, wherein the stent body is in a mesh tube shape; as well as At least two fixing ears, each of which is connected to the bracket body and bent toward the inner side of the bracket body; The fixing ear comprises a fixing part and a connecting rod, one end of the connecting rod is connected to the bracket body, the other end of the connecting rod is connected to the fixing part, and the end of the fixing part away from the connecting rod is a free end; The fixing ear includes a first bending section and a second bending section, wherein the first bending section bends toward the inner side of the bracket body at a greater angle than the second bending section bends toward the inner side of the bracket body, and the first bending section is closer to the bracket body than the second bending section.

2. The valve stent according to claim 1, characterized in that: The first bending section bends toward the inner side of the bracket body at an angle ranging from 10° to 45°, and the second bending section bends toward the inner side of the bracket body at an angle ranging from 5° to 40°.

3. The valve stent according to claim 2, characterized in that: The angle at which the second bending section bends toward the inner side of the bracket body ranges from 15° to 30°.

4. The valve stent according to claim 1, characterized in that: The first bending section includes the connecting rod, and the second bending section includes the fixing portion.

5. The valve stent according to claim 1, characterized in that: The first bending section includes a portion of the connecting rod, and the second bending section includes the fixing portion and another portion of the connecting rod.

6. The valve stent according to claim 5, characterized in that: The connecting rod includes a first connecting section and a second connecting section, one end of the first connecting section is connected to the bracket body, the other end of the first connecting section is connected to one end of the second connecting section, the other end of the second connecting section is connected to the fixing portion, the first bending section includes the first connecting section, and the second bending section includes the second connecting section and the fixing portion.

7. The valve stent according to any one of claims 1 to 6, characterized in that: The plurality of fixing ears have the same shape and are evenly arranged along the circumference of the bracket body.

8. The valve stent according to any one of claims 1 to 6, characterized in that: The fixing portion of each fixing ear has a through hole.

9. The valve stent according to any one of claims 1 to 6, characterized in that: The total length of the fixing ears is between 1 mm and 6 mm.

10. The valve stent according to claim 9, characterized in that: The total length of the fixing ears is between 3 mm and 5 mm.

11. The valve stent according to any one of claims 1 to 6, characterized in that: The fixing ears are manufactured by cutting or weaving.

12. A valve prosthesis, characterized in that: It comprises an artificial valve and a valve stent as described in any one of claims 1 to 11, wherein the artificial valve is fixed on the valve stent.

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