Artificial valves and valve delivery systems

Abstract

The present invention discloses an artificial valve and a valve delivery system, the artificial valve comprises a top bracket, a middle bracket and a bottom bracket, the top bracket, the middle bracket and the bottom bracket are connected in sequence, at least three locking brackets are arranged circumferentially on the top bracket, the top of each locking bracket has a locking end, at least three membrane leaf fixing parts are arranged on the middle bracket; in the unlocked state of each locking end, the diameter of the circumference where the top edges of the three membrane leaf fixing parts are located is Φ1, in the locked state of each locking end, the diameter of the circumference where the top edges of the three membrane leaf fixing parts are located is Φ2, and Φ2 is greater than or equal to 74% of Φ1. The present invention can realize the pre-release of the valve at a near full height in the locked state, and the doctor can fully determine the working condition of the valve after implantation in advance, so as to better determine the subsequent adjustment direction of the implantation strategy.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices, and in particular relates to an artificial valve and a valve delivery system. Background Art

[0002] Aortic valve disease is a common heart valve disease, and its incidence rate increases with age.

[0003] At present, surgical procedures are usually used to replace the diseased valves of patients with artificial heart valves. However, this method is not suitable for some patients who are older or have comorbidities. For these patients, minimally invasive transcatheter aortic valve implantation can be used to replace artificial heart valves. Since transcatheter aortic valve implantation does not require thoracotomy, has the advantages of less trauma and faster recovery, it has received more and more attention and attention.

[0004] Since the rise of transcatheter aortic valve implantation, various manufacturers have successively launched valve delivery devices with various functions, one of the important indicators of which is retrievability. Before the final release of the valve, the valve is usually partially released first, and the fluid dynamics of the partially released (pre-released) valve is evaluated to determine whether the implantation position of the transcatheter aortic valve is appropriate. After the evaluation, if the implantation position of the valve needs to be adjusted, the pre-released valve can be put back into the sheath and repositioned, and the implantation position can be readjusted. This is the recovery operation. Retrievable performance means that the transcatheter aortic valve device can be recovered.

[0005] The full-height pre-release of the valve will help doctors to fully determine the working condition of the valve after implantation in advance, so as to better determine the subsequent adjustment direction of the implantation strategy.

[0006] However, existing valves cannot achieve full-height pre-release, and the valve needs to be locked and constrained by a sheath during release. During pre-release, the sheath of the device will not allow retreat within the full height range, so the valve is not fully released, that is, it cannot be fully retrievable, and doctors cannot fully determine in advance the working condition of the valve after implantation. Summary of the invention

[0007] The purpose of the present invention is to provide an artificial valve and a valve delivery system. The present invention can achieve near-full-height pre-release of the valve in a locked state, and the doctor can fully determine in advance the working condition of the valve after implantation, so as to better determine the subsequent adjustment direction of the implantation strategy.

[0008] The technical solution is as follows:

[0009] The present invention provides an artificial valve, comprising a top bracket, a middle bracket and a bottom bracket, wherein the top bracket, the middle bracket and the bottom bracket are connected in sequence, and at least three locking brackets are circumferentially arranged on the top bracket, and the top of each locking bracket has a locking end, and at least three membrane leaf fixing parts are arranged on the middle bracket; when each locking end is unlocked, the diameter of the circumference of the circle where the upper edges of the three membrane leaf fixing parts are located is Φ1, and when each locking end is locked, the diameter of the circumference of the circle where the upper edges of the three membrane leaf fixing parts are located is Φ2, and Φ2 is greater than or equal to 74% of Φ1.

[0010] In one of the embodiments, an anchoring frame is provided on the middle support, protruding from the circumference and facing the bottom support.

[0011] In one embodiment, the anchoring frame includes a fixed section and a free section, the fixed section protrudes outwardly from the circumference relative to the middle support, and the free section bends inwardly from the circumference relative to the fixed section.

[0012] In one embodiment, the anchor frame has two fixed sections and two free sections, the upper ends of the two fixed sections are connected to the middle bracket, and the ends of the two free sections are connected to each other.

[0013] In one embodiment, the ends of the two free sections are connected to form a terminal head, and a through hole is provided on the terminal head.

[0014] In one of the embodiments, a protective sleeve and / or a developing positioning piece is provided on the perforation.

[0015] In one embodiment, Φ2 is 74% to 120% of Φ1.

[0016] In one embodiment, the structural stiffness of the top support is less than the structural stiffness of the middle support.

[0017] In one embodiment, the middle bracket includes three suture rods, which are the membrane leaf fixing parts, and there are three locking brackets. The structural stiffness of the locking end of each locking bracket is 5% to 50% of the structural stiffness of the suture rod.

[0018] In one embodiment, the middle bracket includes three suture rods, which are the membrane leaf fixing parts, and there are six locking brackets. The structural stiffness of the locking end of each locking bracket is 3% to 45% of the structural stiffness of the suture rod.

[0019] In one of the embodiments, a plurality of membrane leaf fixing holes are provided in the membrane leaf fixing portion.

[0020] In one embodiment, the circumferential diameter of the bottom bracket gradually increases toward the bottom to form a trumpet shape.

[0021] In one of the embodiments, a circumferential skirt is provided on the bottom bracket.

[0022] The present invention also provides an artificial valve, comprising a top bracket, a middle bracket and a bottom bracket, wherein the top bracket, the middle bracket and the bottom bracket are connected in sequence, at least three locking brackets are circumferentially arranged on the top bracket, the top end of the locking bracket has a locking end, and a membrane leaf fixing portion is provided on the middle bracket; the structural stiffness of the top bracket is less than the structural stiffness of the middle bracket.

[0023] In one embodiment, the middle bracket includes three suture rods, which are the membrane leaf fixing parts, and there are three locking brackets. The structural stiffness of the locking end of each locking bracket is 5% to 50% of the structural stiffness of the suture rod.

[0024] In one embodiment, the middle bracket includes three suture rods, which are the membrane leaf fixing parts, and there are six locking brackets. The structural stiffness of the locking end of each locking bracket is 3% to 45% of the structural stiffness of the suture rod.

[0025] In one embodiment, the middle bracket also includes a suture rod and a connecting rod, and the locking bracket, suture rod, connecting rod, and bottom bracket are sequentially connected to form an integrated structure; the maximum cross-sectional area of ​​the locking bracket is 20% to 50% of the minimum cross-sectional area of ​​the suture rod, and the cross-section is perpendicular to the central axis of the entire valve.

[0026] The present invention also provides an artificial valve, comprising a top bracket, a middle bracket and a bottom bracket, wherein the top bracket, the middle bracket and the bottom bracket are connected in sequence, at least three locking brackets are arranged along the circumferential direction of the top bracket, the top end of the locking bracket has a locking end, and a membrane leaf fixing portion is arranged on the middle bracket;

[0027] The middle bracket also includes a suturing rod and a connecting rod. The locking bracket, suturing rod, connecting rod and bottom bracket are connected in sequence to form an integrated structure. The maximum cross-sectional area of ​​the locking bracket is 20% to 50% of the minimum cross-sectional area of ​​the suturing rod, and the cross-sectional area is perpendicular to the central axis of the entire valve.

[0028] The present invention also provides a valve delivery system, comprising an artificial valve and a delivery device, wherein:

[0029] The artificial valve comprises a top bracket, a middle bracket and a bottom bracket, which are connected in sequence, at least three locking brackets are arranged along the circumference of the top bracket, each locking bracket has a locking end at the top end, and at least three membrane leaf fixing parts are arranged on the middle bracket;

[0030] The delivery device comprises a first locking member, a second locking member and a sheath tube, wherein the first locking member and the second locking member are relatively movable, the first locking member has a first locking portion, the second locking member has a second locking portion, a locking position is formed between the first locking portion and the second locking portion, the inner diameter of the sheath tube is larger than the radial dimension of the second locking member, and the sheath tube is movablely sleeved outside the first locking member and the second locking member;

[0031] When the first locking piece and the second locking piece move relative to each other, the locking position is in an unlocked or locked state; in the unlocked state of each locking end, the diameter of the circumference where the uppermost edges of the three membrane leaf fixing parts are located is Φ1, and in the locked state of each locking end, the diameter of the circumference where the uppermost edges of the three membrane leaf fixing parts are located is Φ2, and Φ2 is 74% to 120% of Φ1.

[0032] The technical solution provided by the present invention has the following advantages and effects:

[0033] In the unlocked state, the diameter of the circle where the top edges of the three leaflets are located is Φ1, and the valve is in full working condition. In the full-height pre-release state when the artificial valve is inserted (the valve is completely out of the sheath, but the locking ends of the locking stent are still locked together), the diameter of the circle where the top edges of the three leaflets are located is Φ2. At this time, Φ2 is in the range of 74% to 120% of Φ1, which can ensure that the valve can reach the basic working state in the locked state, and is used for doctors to pre-determine the working condition of the valve after implantation, so as to better determine the subsequent adjustment direction of the implantation strategy without the need to completely unlock and release the artificial valve. In the case that the artificial valve does not meet the requirements, the artificial valve can be easily recovered. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] The accompanying drawings herein show specific examples of the technical solutions described in the present invention, and together with the specific implementation methods, constitute a part of the specification, and are used to explain the technical solutions, principles and effects of the present invention.

[0035] Unless otherwise specified or defined, the same reference numerals in different drawings represent the same or similar technical features, and the same or similar technical features may also be represented by different reference numerals.

[0036] For the convenience of explanation, in the following figures, Figures 1 to 19 The main illustration is of the valve locking device. Figures 20 to 32 The illustrations mainly illustrate artificial valves; among them, some drawings illustrate the combined use of valve locking devices and artificial valves.

[0037] Figure 1 is a structural diagram of the valve locking device according to the first embodiment of the present invention;

[0038] Figure 2is a structural diagram of the valve delivery device according to the first embodiment of the present invention;

[0039] Figure 3 This is a structural diagram of the valve delivery device according to the first embodiment of the present invention, in which the valve is in a full-height pre-release but locked state;

[0040] Figure 4 This is a structural diagram of the valve in a fully recovered state using the valve delivery device described in the first embodiment of the present invention;

[0041] Figure 5 is a partial cross-sectional view of the valve locking device according to the first embodiment of the present invention;

[0042] Figure 6 is a partial schematic diagram of the valve locking device in the locked state according to the first embodiment of the present invention;

[0043] Figure 7 is a partial schematic diagram of the valve locking device in the unlocked state according to the first embodiment of the present invention;

[0044] Figure 8 is a structural diagram of the valve locking device according to the second embodiment of the present invention;

[0045] Fig. 9 is a partial schematic diagram of the valve locking device in the locked state according to the second embodiment of the present invention;

[0046] Fig.10 is a structural diagram of a valve locking device according to a third embodiment of the present invention;

[0047] Fig.11 is a partial schematic diagram of the valve locking device in the locked state according to the third embodiment of the present invention;

[0048] Fig.12 is a structural diagram of a valve locking device according to a fourth embodiment of the present invention;

[0049] Fig.13 is a partial schematic diagram of the valve locking device in a locked state according to the fourth embodiment of the present invention;

[0050] Fig.14 is a structural diagram of a valve locking device according to a fifth embodiment of the present invention;

[0051] Fig.15 It is a partial schematic diagram of the valve locking device according to the fifth embodiment of the present invention in an unlocked but unreleased state;

[0052] Fig.16 is a structural diagram of a valve locking device according to a sixth embodiment of the present invention;

[0053] Fig.17is a partial cross-sectional view of the valve locking device according to Embodiment 6 of the present invention in a locked state;

[0054] Fig.18 is a partial cross-sectional view of the valve locking device according to Embodiment 6 of the present invention in an unlocked state;

[0055] Fig.19 is a partial schematic diagram of the valve locking device in the unlocked state according to the sixth embodiment of the present invention;

[0056] Fig. 20 is a structural diagram of an artificial valve according to Embodiment 7 of the present invention;

[0057] Fig.21 is a structural diagram of an artificial valve stent according to Embodiment 7 of the present invention;

[0058] Fig. 22 It is a partial enlarged view of the anchor frame;

[0059] Fig.23 It is a structural diagram of a developing positioning member installed on an anchoring frame;

[0060] Fig.24 yes Fig.23 a side view of the structure shown;

[0061] Fig.25 It is a structural diagram of a protection kit installed on an anchor frame;

[0062] Fig.26 is a partial enlarged view of the locking end of the artificial valve according to the seventh embodiment of the present invention;

[0063] Fig. 27 is a side view of the artificial valve according to Embodiment 7 of the present invention in a locked (full-height pre-release) state;

[0064] Fig.28 is a side view of the artificial valve according to Embodiment 7 of the present invention in an unlocked (fully released) state;

[0065] Fig.29 This is a first direction view of the structural stiffness test of the locking end in the seventh embodiment;

[0066] Fig.30 yes Fig.29 A partial enlarged view of

[0067] Fig.31 is a second direction view of the structural stiffness test of the locking end in Example 7;

[0068] Fig.32 is a first direction view of the structural stiffness test of the suture rod in the seventh embodiment;

[0069] Fig.33yes Fig. 22 A partial enlarged view of

[0070] Fig.34 is a second direction view of the structural stiffness test of the suture rod in the seventh embodiment;

[0071] Fig.35 is a partial enlarged view of the locking end of the artificial valve described in the eighth embodiment of the present invention;

[0072] Fig.36 is a partial enlarged view of the locking end of the artificial valve according to the ninth embodiment of the present invention;

[0073] Description of reference numerals:

[0074] 10. first locking member, 11. locking seat, 111. locking slope, 12. guide rod, 121. rod body, 122. guide head, 13. matching rod, 14. perforation, 15. snap-fitting convex teeth, 151. groove, 16. rear seat body, 17. placement recess, 20. second locking member, 21. annular body, 22. snap-fitting body, 221. snap-fitting convex part, 222. snap-fitting seam, 30. locking position, 41. first operating member, 42. second operating member, 43. third operating member, 44. sheath, 50. artificial valve, 60. top bracket, 61. locking bracket, 611. lock Fixed end, 6111, locking hole, 6112, locking head, 6113, locking neck, 70, middle bracket, 71, suture rod, 711, membrane leaf fixing hole, 72, connecting rod, 73, anchoring frame, 731, fixed section, 732, free section, 7321, end, 7322, perforation, 733, anchoring protrusion, 74, protection kit, 75, imaging positioning piece, 80, bottom bracket, 81, skirt, 91, aorta, 92, autologous valve, 93, membrane leaf, 941, tensile tester fixture, 942, silicone tube, 943, fixing tooling, 944, pull wire. DETAILED DESCRIPTION

[0075] In order to facilitate the understanding of the present invention, specific embodiments of the present invention will be described in more detail below with reference to the accompanying drawings.

[0076] Unless otherwise specified or defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art. In the context of the actual scenario of the technical solution of the present invention, all technical and scientific terms used herein may also have the meaning corresponding to the purpose of implementing the technical solution of the present invention.

[0077] Unless otherwise specified or defined, the "first, second..." used in this article is merely used to distinguish names and does not represent a specific quantity or order.

[0078] Unless specifically stated or defined otherwise, the term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0079] It should be noted that when a component is considered to be "fixed to" another component, it can be directly fixed to the other component or there can be a central component; when an component is considered to be "connected to" another component, it can be directly connected to the other component or there can be a central component at the same time; when an component is considered to be "installed on" another component, it can be directly installed on the other component or there can be a central component at the same time. When an component is considered to be "set on" another component, it can be directly set on the other component or there can be a central component at the same time.

[0080] Unless otherwise specified or defined, the “said” and “the” used in this document refer to the technical features or technical contents mentioned or described before the corresponding position, and the technical features or technical contents may be the same as or similar to the technical features or technical contents mentioned therein.

[0081] Undoubtedly, technical contents or technical features that are contrary to the purpose of the present invention or are obviously contradictory should be excluded.

[0082] Embodiment 1

[0083] like Figures 1 to 7 As shown, the valve delivery device includes a sheath tube 44, a third operating member 43 and a valve locking device.

[0084] Valve locking devices such as Figure 1 , Figure 5 As shown, it comprises a first locking member 10 and a second locking member 20. The first locking member 10 and the second locking member 20 are relatively movable. The first locking member 10 has a first locking portion, and the second locking member 20 has a second locking portion. A locking position 30 is formed between the first locking portion and the second locking portion. A first operating member 41 is connected to the rear end of the first locking member 10, and a second operating member 42 is connected to the rear end of the second locking member 20. The second operating member 42 is in a hollow tube shape. The first operating member 41 is inserted into the hollow part of the second operating member 42. The axial displacement of the first locking member 10 and the second locking member 20 is controlled by operating the first operating member 41 and the second operating member 42. When the first locking member 10 and the second locking member 20 move relative to each other, the locking position 30 is in an unlocked or locked state.

[0085] The second locking member 20 is annular and includes an annular body 21 and a clamping body 22 . The clamping body 22 is fixedly connected to the annular body 21 and cooperates with the locking seat 11 to form the locking position 30 therebetween. A central hole is provided in the middle of the annular body 21 .

[0086] The first locking member 10 includes a locking seat 11, a guide rod 12, and a matching rod 13. The guide rod 12 is connected to the front end of the locking seat 11, and the matching rod 13 is connected to the rear end of the locking seat 11. The guide rod 12 includes a rod body 121 and a guide head 122. The diameter of the rod body 121 is smaller than the diameter of the locking seat 11 and the guide head 122, and a guiding slope is provided at the front end of the guide head 122.

[0087] Specifically, three finger-shaped clamping protrusions 221 are provided on the clamping body 22, and the clamping protrusions 221 face the front end. A clamping seam 222 is formed between the clamping protrusions 221, and the locking end 611 of the artificial valve 50 is clamped in the clamping seam 222. A locking inclined surface 111 is provided on the locking seat 11, and a locking position 30 is formed between the locking inclined surface 111 and the clamping protrusions 221. The second locking member 20 is sleeved on the matching rod 13 of the first locking member 10 through the central hole, and can move axially relative to the matching rod 13, thereby unlocking or locking the locking position 30.

[0088] Valve delivery devices such as Figure 2 As shown, the third operating member 43 is connected to the rear end of the sheath 44. The sheath 44 and the third operating member 43 are both hollow tubes. The second operating member 42 is inserted into the hollow part of the third operating member 43. The inner diameter of the sheath 44 is larger than the radial dimension of the second locking member 20.

[0089] Combination Figure 3 , Figure 4 , Figure 6 and Figure 7 The first locking member 10 and the second locking member 20 of the valve locking device can move relative to each other. By adjusting the positions of the first locking member 10 and the second locking member 20, the locking position 30 can be unlocked (such as Figure 7 as shown) or locked (as Figure 6 When implanted, the locking end 611 of the artificial valve 50 is locked into the locking position 30, and the artificial valve can be placed in the sheath by controlling the movement of the sheath, as shown in FIG. (4). After the artificial valve 50 is pushed into the aortic root of the patient, the artificial valve 50 can be pre-released at full height (as shown in FIG. Figure 3 As shown), however, the locking position 30 does not need to be unlocked at this time. The doctor can pre-evaluate the artificial valve 50, including the operating status of the artificial valve 50, the release position of the artificial valve 50, etc. If the artificial valve 50 is evaluated to meet the requirements, the locking position 30 is unlocked again. If it is evaluated that it does not meet the requirements, the locking position 30 of the valve locking device is not unlocked, and the valve is pulled into the sheath 44 through the valve locking device, and complete recovery can be performed (as shown in FIG. Figure 4The diameter of the rod body 121 is smaller than the diameter of the locking seat 11 and the guide head 122, and sufficient space can be reserved for the artificial valve 50 when the artificial valve 50 is fully recovered.

[0090] This embodiment can perform full-height pre-release of the artificial valve 50 so that the doctor can fully evaluate the artificial valve 50, and can achieve complete recovery to facilitate implantation.

[0091] Embodiment 2

[0092] like Figure 8 , Fig. 9 As shown, a clamping recess corresponding to the clamping protrusion 221 is provided on the locking seat 11, and the clamping recess cooperates with the clamping protrusion 221. In this embodiment, a clamping protrusion 15 is provided on the locking seat 11, and a plurality of grooves 151 are provided on the clamping protrusion 15. Six finger-shaped clamping protrusions 221 are provided on the clamping body 22. Among the six clamping protrusions 221, three are longer and the remaining three are shorter. When locking, the three long clamping protrusions 221 are clamped on the locking end 611 of the artificial valve 50, and the second locking member 20 is moved axially, and the finger-shaped clamping protrusions 221 are clamped into the grooves 151, so that the locking end 611 of the artificial valve 50 is locked.

[0093] Embodiment 3

[0094] like Fig.10 , Fig.11 As shown, in this embodiment, a rear seat body 16 is provided at the rear end of the locking seat 11, and the locking end 611 of the artificial valve 50 is further limited by the rear seat body 16 to achieve more precise control of the valve position.

[0095] Embodiment 4

[0096] like Fig.12 , Fig.13 As shown, in this embodiment, a clamping recess corresponding to the clamping protrusion 221 is provided on the locking seat 11, and the clamping recess cooperates with the clamping protrusion 221. In this embodiment, a through hole 732214 is provided on the locking seat 11, and six finger-shaped clamping protrusions 221 are provided on the clamping body 22. Among the six clamping protrusions 221, three are longer and the remaining three are shorter. When locking, the three long clamping protrusions 221 are clamped on the locking end 611 of the artificial valve 50, and the second locking member 20 is moved axially, and the finger-shaped clamping protrusions 221 are clamped into the through hole 732214, so that the locking end 611 of the artificial valve 50 is locked.

[0097] Embodiment 5

[0098] like Fig.14 , Fig.15 As shown, in this embodiment, a placement recess 17 is provided on the locking seat 11, and the locking end 611 of the artificial valve 50 is clamped in the placement recess 17, and is axially moved by the second locking piece 20, and the locking end 611 of the artificial valve 50 is limited and locked by the inner wall of its clamping body 22; when the second locking piece 20 moves in the opposite direction, the locking end 611 of the artificial valve 50 is disengaged from the placement recess 17, thereby realizing the unlocking of the artificial valve 50.

[0099] Embodiment 6

[0100] like Figures 16 to 19 As shown, in this embodiment, a locking protrusion 221 is provided on the locking seat 11. Fig.17 As shown, the engaging protrusion 221 cooperates with the inner wall of the engaging body 22 of the second locking member 20, and the locking end 611 of the artificial valve 50 is provided with a locking hole 6111, and the engaging protrusion 221 is engaged in the locking hole 6111 and locks the locking end 611, as shown in FIG. Fig.18 As shown, when the second locking member 20 moves axially relative to the first locking member 10 , the locking end 611 escapes from the engaging protrusion 221 and is unlocked.

[0101] Embodiment 7

[0102] like Figures 20 to 30 As shown, the artificial valve 50 described in this embodiment includes a top bracket 60, a middle bracket 70 and a bottom bracket 80. The top bracket 60, the middle bracket 70 and the bottom bracket 80 are connected in sequence. At least three locking brackets 61 are circumferentially arranged on the top bracket 60. The top of each locking bracket 61 has a locking end 611. At least three membrane leaf fixing parts are arranged on the middle bracket 70. When each locking end 611 is unlocked, the artificial valve is in a fully released state, and the diameter of the circle where the upper edges of the three membrane leaf fixing parts are located is Φ1. When each locking end 611 is locked, the artificial valve is in a full-height pre-release state, and the diameter of the circle where the upper edges of the three membrane leaf fixing parts are located is Φ2. Φ2 is 74% to 120% of Φ1. For comparison, see Figures 27 to 30 shown.

[0103] In the unlocked state, the diameter of the circle where the top edges of the three membrane leaf fixing parts are located is Φ1, and the valve is in a fully working state. In the locked state when the artificial valve 50 is inserted (the locking end 611 of the locking bracket 61 is locked together), the diameter of the circle where the top edges of the three membrane leaf fixing parts are located is Φ2, and Φ2 is in the range of 74% to 120% of Φ1 at this time, which can ensure that the valve can reach a basic working state in the locked state, and is used for doctors to pre-determine the working condition of the valve after implantation, so as to better determine the subsequent adjustment direction of the implantation strategy without completely unlocking and releasing the artificial valve 50. In the case that the artificial valve 50 does not meet the requirements, the artificial valve 50 can be easily recovered.

[0104] In this embodiment, the design consideration range of Φ2 is 74% to 120% of Φ1, and the main considerations are as follows:

[0105] When each locking end 611 is in the locked state, the size of the diameter Φ2 of the circle where the uppermost edges of the three membrane leaf fixing parts are located determines the working condition of the artificial valve during pre-evaluation. If Φ2 is too small, the three membrane leaves 93 will not be able to fit smoothly, thereby causing reflux; if Φ2 is too large, the free edges of the three membrane leaves 93 will not be able to fit together, and the valve will not be tightly closed, which will also cause reflux.

[0106] When the ventricle relaxes, the volume of the ventricle increases, and the blood in the aorta tends to flow back into the ventricle. Due to the effect of blood flow, the membrane leaf 93 will close and prevent blood from flowing back. Correspondingly, the effect of blood on the valve will generate a force, causing the suture rod 71 to deform inward. The deformation of the suture rod 71 is one of the determining factors for whether the valve is well fitted when closed. Therefore, when considering the size of Φ2, the deformation of the suture rod 71 caused by blood flow must be considered at the same time.

[0107] The deformation of the suture rod 71 is determined by factors such as the patient's blood pressure, the structural rigidity of the suture rod, and the size of the valve. According to experience, under the action of blood flow, the deformation of a single suture rod 71 ranges from about 2% to 10% of Φ1. Based on the above values, considering the deformation of the three suture rods 71, when the Φ2 of the three membrane leaf 93 fixing parts in the locked state is 120% of Φ1 in the unlocked state, the membrane leaf 93 may still work normally under the action of blood flow, so 120% of Φ1 is taken as the upper limit of Φ2;

[0108] On the other hand, due to the good compliance of the membrane leaf 93, even if the diameter of the circumference of the three membrane leaf 93 fixing parts is relatively small, the free edge of each membrane leaf 93 can still fit well. According to experience, when the circumference of the top edge of the three membrane leaf fixing parts is 70% of the circumference in the unlocked state, the membrane leaf 93 may still be well closed. According to the conclusion that the minimum deformation of a single suture rod 71 can reach 2% of Φ1, considering the situation of three suture rods 71, when the Φ2 of the three membrane leaf 93 fixing parts in the locked state is 74% of Φ1 in the unlocked state, the valve may still fit well and work normally with the compliance of the membrane leaf 93, so 74% of Φ1 is taken as the lower limit of Φ2.

[0109] The optimal ratio of the diameter Φ2 of the circle where the uppermost edges of the three membrane leaflets are located to Φ1 is in the range of 85% to 110%. Within this ratio range, the three membrane leaflets are well closed in the locked state, thereby accurately predicting the valve function after release.

[0110] The artificial valve 50 can be used in combination with the valve delivery device or valve locking device described in the above embodiments. Figure 3 , Figure 6 , Figure 7 , Fig. 9 , Fig.11 and Fig.13 shown.

[0111] Furthermore, an anchoring frame 73 is provided on the middle bracket 70, which protrudes from the circumference and faces the bottom bracket 80. The anchoring frame 73 can assist in positioning the artificial valve 50 at the root of the aorta 91, reduce the radial force of the bottom bracket 80, and reduce the impact of the artificial valve 50 on electrocardiographic conduction after implantation, thereby reducing the implantation rate of postoperative pacemakers.

[0112] The middle bracket 70 includes a suturing rod 71 and a connecting rod 72. The suturing rod 71 is the membrane leaf fixing part. A plurality of membrane leaf fixing holes 711 are provided here for suturing and fixing the membrane leaf 93. The connecting rod 72 is formed by multiple forks at the lower end of the suturing rod 71. The lower part of the middle bracket 70 and the bottom bracket 80 are both in a grid-like structure. The anchoring frame 73 includes left and right side brackets, each side having a fixed section 731 and a free section 732. The upper ends of the two fixed sections 731 are connected to the connecting rods 72 on both sides, and the ends of the two free sections 732 are connected to each other. The fixed section 731 protrudes outwardly from the circumference relative to the connecting rod 72, and the free section 732 is bent inwardly from the circumference relative to the fixed section 731. The bent parts of the fixed section 731 and the free section 732 form an anchoring convex part 733. The anchoring frame 73 includes left and right side brackets. The structure has reliable anchoring and good stability. Through the different bending directions of the fixed section 731 and the free section 732, the anchoring frame 73 has good compliance characteristics, which is convenient for implantation and recovery, and can achieve repeated positioning; after the positioning is completed, if the artificial valve produces longitudinal displacement, the fixed section 731 can be attached to the inner wall of the aorta 91 and blocked and limited, and the free section 732 can be attached to the inner wall of the aorta 91 and blocked and limited by the autologous valve 92.

[0113] The ends of the two free sections 732 are connected to form an end 7321, and a through hole 7322 is provided on the end 7321. If necessary, a protective kit 74 can be provided on the through hole 7322. The protective kit 74 can be sutured with soft tissue material or polymer material, which can reduce the risk of the anchoring frame 73 damaging the autologous valve 92 or the membrane leaflet 93 of the artificial valve 50. A developing positioning member 75 can also be installed in the through hole 7322, and the developing positioning member 75 needs to be made of a material with good X-ray developing properties.

[0114] In order to meet the characteristics of the artificial valve 50 in the pre-release state, the top support 60 can adopt a smaller structural rigidity than the middle support 70, which can be specifically adopted in the following manner:

[0115] 1. The elastic modulus of the material used for the top bracket 60 is smaller than that of the middle bracket 70;

[0116] 2. The overall length of the top bracket 60 is lengthened so that the locking end 611 is away from the suturing rod. Since the suturing rod is the fixed end of the locking end, lengthening the overall length of the top bracket 60 can make the rigidity of the locking end smaller.

[0117] 3. The top bracket 60 and the middle bracket 70 are processed with the same material to reduce the processing cost while ensuring the overall mechanical strength; the top bracket 60, the middle bracket 70 and the bottom bracket 80 are all made of nickel-titanium alloy. Under this condition, the cross-sectional area of ​​the rod-shaped material of the top bracket 60 is smaller than the cross-sectional area of ​​the rod-shaped material of the middle bracket 70. Preferably, the maximum value of the cross-sectional area of ​​the rod-shaped material of the top bracket 60 is 33% to 95% of the minimum value of the cross-sectional area within the height range of the middle bracket 70, and the cross-sectional area is perpendicular to the central axis of the valve as a whole. When the maximum cross-sectional area within the height range of the top bracket is in the range of 50% to 90% relative to the minimum cross-sectional area within the height range of the middle bracket, the structural stiffness of the locking end and the structural stiffness of the suture rod of the middle bracket can reach a better ratio.

[0118] The locking brackets 61 of the top bracket 60 are generally three or six. When there are three locking brackets 61, the locking end structural stiffness of each locking bracket 61 is 5% to 50% of the structural stiffness of the suture rod of the middle bracket 70. When there are six locking brackets 61, the locking end structural stiffness of each locking bracket 61 is 3% to 45% of the structural stiffness of the suture rod of the middle bracket 70. When the locking end structural stiffness of the locking bracket 61 is between 20% and 40% of the structural stiffness of the suture rod of the middle bracket 70, the diameter Φ2 of the circumference of the uppermost edges of the three membrane leaf fixing parts in the locked state accounts for between 85% and 110% of the diameter Φ1 of the circumference of the uppermost edges of the three membrane leaf fixing parts in the fully released state. Within this ratio range, the three membrane leaflets are well closed in the locked state, so that the valve function after release can be accurately estimated.

[0119] Towards the bottom, the circumferential diameter of the bottom bracket 80 gradually increases to form a trumpet shape, which can produce a larger radial compression after the artificial valve 50 is implanted to prevent the artificial valve 50 from shifting during operation. The bottom bracket 80 is provided with a circumferential skirt 81, which can be made of pericardial material or polymer material.

[0120] In this embodiment, the structural rigidity test method of a single locking end 611 is as follows: Fig.29 , Fig.30 and Fig.31As shown, at an ambient temperature of 37°C, the valve stent is released into the silicone tube 942, and the inner diameter of the silicone tube 942 is selected to be within the diameter range of the human aortic valve ring suitable for the artificial valve. The silicone tube 942 is fixed to the platform of the universal tensile test instrument by a fixing fixture 943, wherein the inner diameter of the fixing fixture 943 fits the inner diameter of the silicone tube 942. The locking end 611 of the valve stent is bound with a pull wire 944 and locked with the tensile tester fixture 941, and the locking end 611 to be measured is kept aligned with the tensile tester fixture 941, that is, the pull wire 944 is kept in a vertical direction. After the universal tensile tester is initially zeroed, the tensile tester fixture is operated to make the locking end 611 in an undeformed state and the pull wire 944 just straight, and this position is set as the zero point and the force value and deformation of the universal tensile tester are adjusted to zero, and the force value under the upward tensile displacement of 10mm is tested, and the ratio of the maximum force value to the displacement is taken as the structural stiffness.

[0121] The structural stiffness test method of a single suture rod is the same as above, e.g. Fig.32 , Fig.33 and Fig.34 shown.

[0122] Embodiment 8

[0123] like Fig.35 As shown, in this embodiment, the structure of the locking end 611 of the artificial valve 50 is different. The locking end 611 has a locking head 6112 , and the inner side size of the locking head 6112 becomes smaller to form a locking neck 6113 .

[0124] See also Fig.14 , Fig.15 As shown, during implantation or recovery, a placement recess 17 is provided on the locking seat 11 of the valve delivery device, and the locking end 611 of the artificial valve 50 is clamped in the placement recess 17 and is axially moved by the second locking piece 20, and the locking end 611 of the artificial valve 50 is limited and locked by the inner wall of its clamping body 22; when the second locking piece 20 moves in the opposite direction, the locking end 611 of the artificial valve 50 is disengaged from the placement recess 17, thereby realizing the unlocking of the artificial valve 50.

[0125] Embodiment 9

[0126] like Fig.36 As shown, in this embodiment, the structure of the locking end 611 of the artificial valve is different, and the locking end 611 is provided with a locking hole 6111.

[0127] See also Figures 16 to 19As shown, in this embodiment, the locking seat 11 of the valve delivery device is provided with a snap-fitting protrusion 221, and the snap-fitting protrusion 221 cooperates with the inner wall of the snap-fitting body 22 of the second locking member 20, and the locking end 611 of the artificial valve 50 is provided with a locking hole 6111, and the snap-fitting protrusion 221 is clamped in the locking hole 6111 and locks the locking end 611, as shown in FIG. Fig.18 As shown, when the second locking member 20 moves axially relative to the first locking member 10 , the locking end 611 escapes from the engaging protrusion 221 and is unlocked.

[0128] The purpose of the above embodiments is to exemplarily reproduce and deduce the technical solution of the present invention, and to fully describe the technical solution, purpose and effect of the present invention. Its purpose is to make the public understand the disclosed content of the present invention more thoroughly and comprehensively, and it does not limit the scope of protection of the present invention.

[0129] The above embodiments are not exhaustive enumerations of the present invention, and there may be multiple other implementations not listed. Any replacement and improvement made without violating the concept of the present invention shall fall within the protection scope of the present invention.

Claims

1. An artificial valve, characterized in that: It includes a top bracket, a middle bracket and a bottom bracket, which are connected in sequence, at least three locking brackets are arranged on the top bracket along the circumference, and the top of each locking bracket has a locking end, and at least three membrane leaf fixing parts are arranged on the middle bracket; When each locking end is unlocked, the diameter of the circle where the top edges of the three membrane leaf fixing parts are located is Φ1. When each locking end is locked and fully released, the diameter of the circle where the top edges of the three membrane leaf fixing parts are located is Φ2, and Φ2 is 74% to 120% of Φ1. The structural rigidity of the top bracket is less than that of the middle bracket; The middle bracket includes three suture rods, which are the membrane leaf fixing parts, and the structural stiffness of the locking end of each locking bracket is 5% to 45% of the structural stiffness of the suture rod; The full-height pre-release state is that the valve is completely separated from the sheath, but the locking ends of the locking stent are still locked together.

2. The artificial valve according to claim 1, characterized in that: An anchoring frame is provided on the middle support, which protrudes from the circumference and faces the bottom support.

3. The artificial valve according to claim 2, characterized in that: The anchoring frame comprises a fixed section and a free section. The fixed section protrudes outwardly from the circumference relative to the middle support, and the free section bends inwardly from the circumference relative to the fixed section.

4. The artificial valve according to claim 3, characterized in that: The anchoring frame has two fixed sections and two free sections, the upper ends of the two fixed sections are connected to the middle bracket, and the ends of the two free sections are connected to each other.

5. The artificial valve according to claim 4, characterized in that: The ends of the two free sections are connected to form a terminal head, and a through hole is arranged on the terminal head.

6. The artificial valve according to claim 5, characterized in that: A protection kit and / or a developing positioning piece is arranged on the perforation.

7. The artificial valve according to claim 1, characterized in that: There are three locking brackets.

8. The artificial valve according to claim 1, characterized in that: There are six locking brackets.

9. The artificial valve according to any one of claims 1 to 6, characterized in that: A plurality of membrane leaf fixing holes are provided in the membrane leaf fixing portion.

10. The artificial valve according to any one of claims 1 to 6, characterized in that: Towards the bottom, the circumferential diameter of the bottom bracket gradually increases to form a trumpet shape.

11. The artificial valve according to any one of claims 1 to 6, characterized in that: The bottom bracket is provided with a circumferential skirt.

12. The artificial valve according to claim 1, characterized in that: The middle bracket also includes a suturing rod and a connecting rod, and the locking bracket, suturing rod, connecting rod and bottom bracket are connected in sequence to form an integrated structure; the maximum cross-sectional area of ​​the locking bracket is 20% to 50% of the minimum cross-sectional area of ​​the suturing rod, and the cross-section is perpendicular to the central axis of the entire valve.

13. An artificial valve, characterized in that: It includes a top bracket, a middle bracket and a bottom bracket, which are connected in sequence, at least three locking brackets are arranged along the circumference of the top bracket, the top end of the locking bracket has a locking end, and a membrane leaf fixing part is arranged on the middle bracket; The middle bracket also includes a suture rod and a connecting rod, and the locking bracket, the suture rod, the connecting rod, and the bottom bracket are sequentially connected to form an integrated structure; the maximum cross-sectional area of ​​the locking bracket is 20% to 50% of the minimum cross-sectional area of ​​the suture rod, and the cross-sectional area is perpendicular to the central axis of the valve as a whole; When each locking end is unlocked, the diameter of the circle where the upper edge of each membrane leaf fixing part is located is Φ1, and when each locking end is locked and fully released, the diameter of the circle where the upper edge of each membrane leaf fixing part is located is Φ2, and Φ2 is 74% to 120% of Φ1; The middle bracket includes three suture rods, which are the membrane leaf fixing parts, and the structural stiffness of the locking end of each locking bracket is 5% to 45% of the structural stiffness of the suture rod; The full-height pre-release state is that the valve is completely separated from the sheath, but the locking ends of the locking stent are still locked together.

14. A valve delivery system, characterized in that: Comprising an artificial valve and a delivery device, wherein: The artificial valve comprises a top bracket, a middle bracket and a bottom bracket, which are connected in sequence, at least three locking brackets are arranged along the circumference of the top bracket, each locking bracket has a locking end at the top end, and at least three membrane leaf fixing parts are arranged on the middle bracket; The delivery device comprises a first locking member, a second locking member and a sheath tube, wherein the first locking member and the second locking member are relatively movable, the first locking member has a first locking portion, the second locking member has a second locking portion, a locking position is formed between the first locking portion and the second locking portion, the inner diameter of the sheath tube is larger than the radial dimension of the second locking member, and the sheath tube is movablely sleeved outside the first locking member and the second locking member; When the first locking member and the second locking member move relative to each other, the locking position is in an unlocked or locked state; in the unlocked state of each locking end, the diameter of the circumference of the uppermost edge of the three membrane leaf fixing parts is Φ1, and in the locked and full-height pre-released state of each locking end, the diameter of the circumference of the uppermost edge of the three membrane leaf fixing parts is Φ2, and Φ2 is 74% to 120% of Φ1; The structural rigidity of the top bracket is less than that of the middle bracket; The middle bracket includes three suture rods, which are the membrane leaf fixing parts, and the structural stiffness of the locking end of each locking bracket is 5% to 45% of the structural stiffness of the suture rod; The full-height pre-release state is that the valve is completely separated from the sheath, but the locking ends of the locking stent are still locked together.

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