Prosthetic heart valve device and implantation method thereof

Abstract

The invention discloses an artificial heart valve device and an implantation method, and belongs to the technical field of medical instruments.The artificial heart valve device comprises a valve support, a skirt edge and an artificial valve, the valve support comprises a control support, a body and at least three positioning parts, the artificial valve is installed on the control support, the skirt edge is connected outside the body in a sleeving mode, and the positioning parts are arranged on the skirt edge; the first end of the positioning piece is fixed to the control support, and the second end of the positioning piece is matched with the top of the skirt edge. The three positioning pieces are distributed in the circumferential direction of the valve support and used for supporting the top of the skirt edge. When the valve support is in a natural state, the diameter of the top of the skirt is larger than that of the waist of the skirt. The three positioning pieces unfold the top of the skirt edge, the top of the skirt edge is in a funnel shape after being unfolded, the conveying mechanism is pushed towards the left ventricle, in this way, it can be ensured that the top of the skirt edge abuts against the autologous valve, a sealing area is formed between the top of the skirt edge and the autologous valve, and by means of the positioning sealing area, perivalvular leakage can be prevented.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, in particular to an artificial heart valve device and an implantation method thereof. Background Art

[0002] Heart valve disease is a common heart valve disease, and its incidence rate gradually increases with age. For this disease, surgical valve replacement is usually performed on the patient's diseased valve. However, this method is not suitable for some elderly patients with comorbidities. For these patients, minimally invasive artificial heart valve replacement can be used.

[0003] Transcatheter artificial heart valve products are mainly divided into two types: balloon-expandable valves and self-expandable valves. In the self-expandable valve, the valve is first radially compressed and then placed in the sheath of the delivery mechanism. The sheath carries the compressed valve from the blood vessel into the location of the heart disease, and then the handle of the delivery mechanism is used to fix the self-expandable valve and move the sheath back relative to the valve, thereby achieving the effect of releasing the valve. However, existing valves are prone to paravalvular leakage after release. Summary of the invention

[0004] The purpose of the present invention is to improve the problem of paravalvular leakage in existing artificial heart valve devices, and to provide an artificial heart valve device and an implantation method thereof.

[0005] The technical solutions to achieve the above objectives include the following:

[0006] Prosthetic heart valve devices, including:

[0007] A valve stent, a skirt, and an artificial valve, wherein the valve stent comprises a control stent, a main body, and at least three positioning members, wherein the artificial valve is mounted on the control stent, the skirt is sleeved outside the main body, and the first end of the positioning member is fixed to the control stent, and the second end of the positioning member is matched with the top of the skirt;

[0008] Among them, three positioning members are distributed in the circumferential direction of the valve stent, and the three positioning members are used to support the top of the skirt; when the valve stent is in a natural state, the diameter of the top of the skirt is greater than the diameter of the waist of the skirt.

[0009] In one embodiment, the number of the positioning elements is at least four, and the four positioning elements are equidistantly arranged along the circumference of the valve stent.

[0010] In one embodiment, the positioning member has a first wire hole, the valve support also has a pull wire, and the skirt also has a first connecting end and a second connecting end; the first end of the pull wire is fixed to the control support, and the second end of the pull wire passes through the first connecting end, the first wire hole, the second connecting end in sequence, and is fixed to the skirt.

[0011] In one embodiment, the first connecting end and the second connecting end are distributed along the axial center line direction of the skirt; on one side of the skirt, a surplus portion is formed between the first connecting end and the second connecting end;

[0012] When the valve stent is in a folded state, the surplus portion is in a folded state; when the valve stent is in an expanded state, the surplus portion is in an expanded state.

[0013] In one embodiment, the pull wire has an extension section, and the length of the extension section when the valve stent is in a closed state is smaller than the length of the extension section when the valve stent is in an expanded state.

[0014] In one embodiment, at least a portion of the positioning element is in a bent wave shape.

[0015] In one embodiment, the positioning member includes a first pull rod and a second pull rod, the first pull rod and the second pull rod are both bent in a wave shape, the first end of the first pull rod and the first end of the second pull rod are an integral structure and form a first connecting rod, the second end of the first pull rod and the second end of the second pull rod are an integral structure and form a second connecting rod, and the second connecting rod is provided with a first wire hole;

[0016] The first connecting rod is fixed to the control bracket, and the second connecting rod is matched with the skirt.

[0017] In one embodiment, the control bracket has multiple control ends and a third connecting end, and the artificial heart valve device also has a transmission member. The multiple control ends and the multiple third connecting ends are opposite to and staggered with each other. The first end of the positioning member is installed on the third connecting end, the first end of the transmission member is fixed to the third connecting end, and the second end of the transmission member is fixed to the main body.

[0018] In one embodiment, the transmission member includes a first support rod and a second support rod, the first ends of the first support rod and the second support rod are fixed to the third connecting end of the control bracket, and the first ends of the first support rod and the second support rod are arranged far apart; the second ends of the first support rod and the second support rod are fixed to the main body, and the second ends of the first support rod and the second support rod are arranged close to each other.

[0019] The present invention also provides a method for implanting an artificial heart valve device, comprising the following steps:

[0020] Step 1: installing the artificial heart valve device in the delivery mechanism, with the artificial heart valve device in a closed state;

[0021] Step 2: The delivery mechanism delivers the artificial heart valve device to a preset position, and the first sheath of the delivery mechanism releases the control stent;

[0022] Step 3: Control the stent to drive the artificial valve to unfold, and drive the first end of the positioning member to move, and the second end of the positioning member drives the top of the skirt to unfold;

[0023] Step 4: The second sheath tube of the conveying mechanism releases the main body, and the main body opens the skirt, wherein the diameter of the top of the skirt is greater than the diameter of the waist of the skirt.

[0024] The technical solution provided by the present invention has the following advantages and effects:

[0025] When the delivery mechanism delivers the artificial heart valve device to the preset position, the first sheath of the delivery mechanism is released first, the control stent is unfolded at the preset position, the control stent drives the three positioning members to move, and the three positioning members unfold the top of the skirt, so that the diameter of the top of the skirt is greater than the diameter of the waist of the skirt, and the top of the skirt is funnel-shaped after unfolding. At this time, the delivery mechanism can be pushed toward the left ventricle, so as to ensure that the top of the skirt is against the native valve, which plays a role in positioning the artificial heart valve device. At the same time, a sealing area is formed between the top of the skirt and the native valve. With the help of the positioning sealing area, paravalvular leakage can be prevented, and the artificial heart valve device is more stable in the axial direction of the left ventricular outflow tract. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] 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.

[0027] 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.

[0028] Figure 1 is a schematic diagram of an artificial heart valve device according to an embodiment of the present invention;

[0029] Figure 2 is a schematic diagram of an artificial valve in an open state in one embodiment of the present invention;

[0030] Figure 3 is a schematic diagram of a closed state of an artificial valve in one embodiment of the present invention;

[0031] Figure 4 is a schematic diagram of the position between the positioning member and the native valve in one embodiment of the present invention;

[0032] Figure 5 is a front view of a valve stent in one embodiment of the present invention;

[0033] Figure 6 is a schematic diagram of delivery of an artificial heart valve device according to an embodiment of the present invention;

[0034] Figure 7 is a schematic diagram of the deployment of an artificial heart valve device after implantation in one embodiment of the present invention;

[0035] Figure 8 Schematic diagram of the cooperation between an artificial heart valve device and a native valve in one embodiment of the present invention Figure 1 ;

[0036] Fig. 9 Schematic diagram of the cooperation between an artificial heart valve device and a native valve in one embodiment of the present invention Figure 2 ;

[0037] Fig.10 FIG. 1 is a schematic diagram of the installation position of an artificial heart valve device in one embodiment of the present invention. Figure 1 ;

[0038] Fig.11 FIG. 1 is a schematic diagram of the installation position of an artificial heart valve device in one embodiment of the present invention. Figure 2 ;

[0039] Fig.12 is a schematic diagram of a pull wire of an artificial heart valve device after contraction in one embodiment of the present invention;

[0040] Fig.13 is a schematic diagram of a pull wire after the artificial heart valve device is deployed in one embodiment of the present invention;

[0041] Fig.14 Schematic diagram of a control bracket in one embodiment of the present invention Figure 1 ;

[0042] Fig.15 Schematic diagram of a control bracket in one embodiment of the present invention Figure 2 ;

[0043] Fig.16 is a schematic diagram of a positioning member in one embodiment of the present invention;

[0044] Fig.17 is a schematic diagram of the cooperation between the pull wire and the positioning member in one embodiment of the present invention;

[0045] Description of reference numerals:

[0046] 100. Artificial heart valve devices;

[0047] 11. artificial valve; 12. skirt; 121. first connection end; 122. second connection end; 123. surplus portion; 13. suture edge;

[0048] 2. Valve support; 21. Control support; 211. Control end; 212. Third connection end; 22. Main body; 221. First support rod; 222. Second support rod; 23. Suturing rod; 24. Positioning member; 241. First thread hole; 242. First pull rod; 243. Second pull rod; 244. First connecting rod; 245. Second connecting rod; 246. Intersection; 247. Telescopic hole; 248. Second thread hole;

[0049] 25, transmission member; 251, first support rod; 252, second support rod;

[0050] 3. Pull wire; 31. Extension section; 32. Fixed end;

[0051] 4. conveying mechanism; 41. first sheath tube; 42. second sheath tube;

[0052] 5. Left ventricular outflow tract; 51. Native valve; 52. Space; 53. Junction point;

[0053] 6. Aortic sinus. DETAILED DESCRIPTION

[0054] 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.

[0055] 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.

[0056] 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.

[0057] 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.

[0058] Embodiment 1

[0059] Research has found that the common reason for paravalvular leakage caused by self-expanding artificial heart valves with protrusions is that in actual operation, the artificial valve released through the catheter is not coaxial with the native valve or the implantation position is too deep (the protrusion is located in the native valve); the protrusions on the stent may be located within the calcification height of the native valve after one or more releases. Due to the self-expanding effect of the stent in the body, the protrusions will exert a certain force on the calcification of the native valve. The calcified valve is usually relatively rigid, and its part cannot fit the contour shape of the stent, so a gap will be formed between the stent and the calcified valve. When the left ventricle contracts, the artificial valve opens, and the blood in the left ventricle flows to the aorta; when the left ventricle relaxes, the artificial valve closes, and blood easily returns to the left ventricle through this gap, forming a paravalvular leakage.

[0060] This embodiment provides an artificial heart valve device 100, such as Figures 1 to 5 As shown, it includes: a valve stent 2, a skirt 12, and an artificial valve 11. The valve stent 2 includes a control stent 21, a main body 22, and at least three positioning members 24. The artificial valve 11 is installed on the control stent 21, and the skirt 12 is sleeved on the outside of the main body 22. The first end of the positioning member 24 is fixed to the control stent 21, and the second end of the positioning member 24 is matched with the top of the skirt 12; the three positioning members 24 are distributed in the circumferential direction of the valve stent 2, and the three positioning members 24 are used to support the top of the skirt 12; when the valve stent 2 is in a natural state, the diameter of the top of the skirt 12 is greater than the diameter of the waist of the skirt 12.

[0061] Since the first end of the positioning member 24 is fixed to the control bracket 21, the starting point of the positioning member 24 is at a higher position in the artificial heart valve device 100. When the artificial heart valve device 100 is transported, when the artificial valve 11 is transported to the aortic sinus 6, the first sheath 41 is released first. After the control bracket 21 is unfolded, the positioning member 24 can be driven to unfold. An anchor point is formed between the second end of the positioning member 24 and the top of the skirt 12. The anchor point is against the native valve 51, thereby realizing the positioning effect on the artificial heart valve device 100 and improving the vertical stability between the artificial heart valve device 100 and the native valve 51. Since three positioning members 24 are used to cooperate with the top of the skirt 12, and the three positioning members 24 are distributed in the circumferential direction of the valve stent 2, no matter whether the artificial heart valve device 100 is in a high position and whether it is coaxial or non-coaxial with the aortic sinus 6, at least at least one positioning member 24 can be ensured to drive the top of the skirt 12 to unfold, so that an anchor point is formed between the top of the skirt 12 and the native valve 51, thereby improving the fault tolerance of the artificial heart valve device 100 in installation and positioning.

[0062] Moreover, as long as the operator follows the operating specifications, the artificial heart valve device 100 can be placed in a high position or coaxially or non-coaxially with the aortic sinus 6; in terms of operation, there is no difficulty in implanting the artificial heart valve device 100 in a high position or coaxially or non-coaxially with the aortic sinus 6. It can be seen that the anchoring and sealing effects of the artificial heart valve device 100 in this embodiment are better than those of conventional valves. Of course, if the artificial heart valve device 100 is implanted too low, the positioning member 24 may be completely located in the autologous valve 51, and the top of the skirt 12 may not be opened by the positioning member 24 at this time; but at this time, the skirt 12 can also play the role of an ordinary valve, and its anchoring function is also equivalent to that of an ordinary cylindrical self-expanding valve. It should be noted that low-position implantation is related to improper operation of the operator and has no direct or indirect connection with the structure of the artificial heart valve device 100 in this embodiment.

[0063] Furthermore, the autologous valve 51 includes two or three native leaflets, and there is a junction 53 between two adjacent native leaflets. This embodiment focuses on the application scenario of the valve stent 2 in three native leaflets. The artificial valve 11 includes three artificial leaflets, and there is a suture edge 13 between the three artificial leaflets. The control stent 21 has a suture rod 23, and a plurality of suture holes are arranged on the suture rod 23 along the longitudinal direction for fixing the artificial leaflets. The artificial valve 11 is equivalent to the aortic valve of the human body. When the left ventricle contracts, the artificial valve 11 opens, and blood flows from the left ventricle to the aorta; when the left ventricle relaxes, the artificial valve 11 closes to prevent blood from flowing back to the left ventricle.

[0064] Specifically, when the delivery mechanism 4 delivers the artificial heart valve device 100 to the preset position, the first sheath 41 of the delivery mechanism 4 is released first, the control stent 21 is unfolded at the preset position, the control stent 21 drives the three positioning members 24 to move, and the three positioning members 24 unfold the top of the skirt 12, so that the diameter of the top of the skirt 12 is greater than the diameter of the waist of the skirt 12, and the top of the skirt 12 is funnel-shaped after unfolding. At this time, the delivery mechanism 4 can be pushed toward the left ventricle, so that the top of the skirt 12 can be ensured to be against the native valve 51, which plays a role in positioning the artificial heart valve device 100. At the same time, a sealing area is formed between the top of the skirt 12 and the native valve 51. With the help of the positioning sealing area, paravalvular leakage can be prevented, and the artificial heart valve device 100 is more stable in the axial direction of the left ventricular outflow tract 5.

[0065] After the positioning member 24 unfolds the top of the skirt 12 , the second sheath 42 is released, so that the main body 22 is unfolded in the left ventricular outflow tract 5 and the anatomical structure above it, and the waist and bottom of the skirt 12 are stretched open.

[0066] It can be further understood that when the positioning member 24 unfolds the top of the skirt 12, an anchor point is formed between the skirt 12 and the native valve 51. The anchor point is in the axial direction of the skirt 12, so that the artificial heart valve device 100 and the native valve 51 are against each other, thereby improving the stability of the skirt 12; and the skirt 12 has a certain elasticity, which also forms a flexible contact between the skirt 12 and the native valve 51. When the left ventricle is in diastole, the artificial valve 11 is closed to prevent blood from flowing back to the left ventricle. Moreover, the blood flows back to the top of the skirt 12 and acts on the top of the skirt 12 again, so that the top of the skirt 12 is bent, increasing the fitting area between the top of the skirt 12 and the native valve 51, and forming a larger sealing area between the skirt 12 and the native valve 41 to prevent blood from flowing back to the left ventricle. When the left ventricle contracts, the artificial valve 11 opens, and the blood in the left ventricle flows to the aorta. The blood has a certain flow rate. The force generated by the blood flowing to the aorta will push the gap 52 between the skirt 12 and the native valve 51 to open, further increasing the opening area of ​​the artificial valve 11 and increasing the blood flow to the aorta.

[0067] Moreover, three positioning members 24 are arranged in a circumferential direction of the valve support 2, and the three positioning members 24 are used to support the top of the skirt 12. The probability that the three positioning members 24 are located at the intersection point 53 of the native valve 51 is very small; in general, at least one positioning member 24 is located outside the intersection point 53 of the native valve 51, and the positioning member 24 will hook the top of the skirt 12, so that the top of the skirt 12 is against the native valve 51, and the top of the skirt 12 will form a sealing area with the native valve 51. Therefore, the provision of three positioning members 24 can increase the fault tolerance of the artificial heart valve device 100 and greatly improve the practicality of the artificial heart valve device 100.

[0068] In addition, the protrusion (positioning) structure in the prior art is basically installed in the main body 22. During the release process, the protrusion structure cannot be expanded to the maximum extent due to the limited expansion of the main body 22. Therefore, it is difficult to use the protrusion structure and the native valve 51 to produce a mutual resistance effect during the release process, that is, it is difficult to achieve the positioning function; due to the poor positioning effect, the protrusion structure cannot be ensured to be placed above the native valve 51. When the protrusion structure is placed in and below the native valve, the reaction force from the calcified leaflets will cause the protrusion structure to deform, thereby generating inward pressure on the main body 22 that initiates the protrusion structure and deforming it, resulting in a reduction in the opening area of ​​the artificial valve 11 installed in the main body 22. In this embodiment, the positioning member 24 is initiated in the control bracket 21. After the first sheath 41 is withdrawn, the positioning member 24 can be expanded to a great extent for easy positioning. Since the positioning member 24 is installed on the control bracket 21 and has a good expansion function, the positioning member 24 can be placed above the native valve 51. Therefore, the reaction force from the calcified leaflets will not produce additional morphological influences due to the presence of the positioning member 24. Therefore, the installation position of the positioning member 24 in this embodiment has no effect on the opening area of ​​the artificial valve 11.

[0069] In addition, if the artificial heart valve device 100 is implanted too low, the positioning member 24 is located inside the native valve 51, and the positioning member 24 is compressed by calcification. Its initial position is located on the control bracket 21, and the stiffness of the control bracket 21 is greatly different from that of the main body 22, that is, the limited deformation of the control bracket 21 cannot affect the overall shape of the main body 22.

[0070] Preferably, the number of the positioning members 24 is four, and the four positioning members 24 are equidistantly arranged along the circumference of the valve stent 2. Specifically, when the number of the positioning members 24 is four, at most only one positioning member 24 among the four positioning members 24 may be arranged on the intersection point 53 of the native valve 51; ensure that there are three positioning members 24 for staggered arrangement with the intersection point 53 of the native valve 51, so that the top of the skirt 12 has at least three abutment points, and these three abutment points are located in the axial direction of the left ventricular outflow tract 5, further improving the axial stability of the artificial heart valve device 100 after implantation. And there is a large area of ​​sealing area between the native valve 51 and the skirt 12, which further prevents paravalvular leakage.

[0071] Preferably, Figure 3 and Figure 4As shown, the number of the positioning members 24 is six, and the six positioning members 24 can be equidistantly arranged along the circumference of the valve stent 2; among the six positioning members 24, if three positioning members 24 are arranged on the intersection point 53 of the native valve 51, then the remaining three positioning members 24 are arranged between the native valve 51 and the aortic sinus 6, and the control stent 21 is unfolded, driving the remaining three positioning members 24 to unfold, and expanding the area of ​​the top of the skirt 12, so that the diameter of the top of the skirt 12 is larger than the diameter of the waist of the skirt 12, thereby forming a larger sealing area, further improving the anti-valvular leakage performance.

[0072] Embodiment 2

[0073] After the artificial heart valve device 100 is implanted, the top of the skirt 12 has a sufficient surplus portion to contact the top of the native valve 51, or hang on the top of the native valve 51, thereby forming a sealing area. Figures 12 to 15 As shown, the positioning member 24 has a first wire hole 241, the valve support 2 also has a pull wire 3, and the skirt 12 also has a first connecting end 121 and a second connecting end 122; the first end of the pull wire 3 is fixed to the control support 21, and the second end of the pull wire 3 passes through the first connecting end 121, the first wire hole 241, and the second connecting end 122 in sequence, and is fixed to the skirt 12.

[0074] Specifically, after the pull wire 3 is fixed to the control bracket 21, the second end of the pull wire 3 passes through the first connection end 121, the first wire hole 241, and the second connection end 122 in sequence and is fixed to the skirt 12. Fig.13 As shown, when the artificial heart valve device 100 is deployed, at least a portion of the pull wire 3 is located between the first connecting end 121 and the second connecting end 122; Fig.12 As shown, when the artificial heart valve device 100 is in a closed state, the position between the first connection end 121 and the second connection end 122 on the skirt 12 is folded, and the top of the skirt 12 has a certain surplus, so that after the artificial heart valve device 100 is unfolded, the positioning member 24 can pull the top of the skirt 12 to unfold. Moreover, when the left ventricle contracts, the artificial valve 11 opens, and blood flows to the aorta, which can push the surplus part 123 at the top of the skirt 12 to unfold. The blood flow has a certain flow rate and pushes the gap 52 between the top of the skirt 12 and the native valve 51 to open, thereby increasing the opening area of ​​the artificial valve 11.

[0075] like Figure 8 and Fig. 9 As shown, there is a gap 52 between the skirt 12 and the native valve 51. When the positioning member 24 expands the top of the skirt 12, the skirt 12 fits against the inner wall of the native valve 51, thereby eliminating the gap 52 and forming a sealing area at the top of the skirt 12.

[0076] Preferably, Fig.12 and Fig.13 As shown, the first connection end 121 and the second connection end 122 are arranged along the axis direction of the skirt 12; on one side of the skirt 12, a surplus portion 123 is formed between the first connection end 121 and the second connection end 122; when the valve stent 2 is in a closed state, the surplus portion 123 is in a folded state; when the valve stent 2 is in an unfolded state, the surplus portion 123 is in an unfolded state. Specifically, when the valve stent 2 is unfolded, the top of the skirt 12 has enough part for the positioning member 24 to pull or move, and the surplus portion 123 is in an unfolded state after moving. Under the action of the positioning member 24, the top diameter of the skirt 12 is greater than the diameter of the waist of the skirt 12, and a larger sealing area is formed at the top of the skirt 12.

[0077] Preferably, Fig.12 and Fig.13 As shown, the pull wire 3 has an extension section 31, and the length of the extension section 3 of the valve stent 2 in the closed state is less than the length of the extension section 3 of the valve stent 2 in the expanded state. Fig.16 As shown, in the natural state, the surroundings of the positioning member 24 can be regarded as a quadrilateral, and the four sides are A, B, C, and D. During the process of loading the artificial heart valve device 100 into the sheath, the lengths of A, B, C, and D remain basically unchanged, but the angle between A and B becomes smaller, and the angle between C and D becomes smaller, so the length of the diagonal line L between the two angles will increase. Since the length of the pull wire 3 is fixed, when the diagonal line L increases, the pull wire 3 will lift the fixed point P on the skirt 12, and the skirt 12 will form a wrinkle (surplus part 123) below the positioning member 24; in this embodiment, this fixed point P is the fixed end 32 of the pull wire 3.

[0078] When the artificial heart valve device 100 is released, the skirt 12 has a folded surplus portion 123 reserved below the positioning member 24, which facilitates the better expansion of the positioning member 24. After the top of the skirt 12 is driven by the positioning member 24 to unfold, the overall positioning and sealing of the artificial heart valve device 100 can be facilitated. Fig.13 , the pull line 3 is relatively loose in the natural state, and the fixing point P of the skirt 12 is not subjected to force; Fig.12 When the sheath is retracted, the fixed point P is subjected to the tension from the pull wire 3, forming wrinkles.

[0079] In some embodiments, the positioning member 24 is at least partially in a bent wavy shape. Specifically, since the elastic modulus of the pull wire 3 is relatively large, when the first sheath tube 41 is released, the control bracket 21 drives the first end of the positioning member 24 to move, and the control bracket 21 also drives the pull wire 3 to move when moving. The positioning member 24 is in a bent wavy shape, and the positioning member 24 is generally made of metal. The elastic modulus of the positioning member 24 is relatively small, and the positioning member 24 has a certain elasticity. The positioning member 24 can play a certain buffering role, avoiding excessive pulling of the pull wire 3 on the top of the skirt 12, and improving the stability of the cooperation between the pull wire 3 and the top of the skirt 12.

[0080] Furthermore, when the artificial valve 11 is sheathed, the folding of the control stent 21 generates a pulling force on the pull wire 3, and the skirt 12 is pulled by the fixed end 32 and approaches the first connecting end 121, forming a wrinkled surplus portion 123. In this process, the first connecting end 121 will hinder the movement of the pull wire 3, that is, the first connecting end 121 will be subject to friction resistance from the pull wire 3. Setting the positioning member 24 in a wavy shape helps to buffer this friction resistance and avoid excessive pulling of the pull wire 3 by the first connecting end 121. Relying on this buffering effect, it is also possible to avoid excessive pulling of the pull wire 3 on the top of the skirt 12, thereby improving the stability of the fit between the pull wire 3 and the top of the skirt 12.

[0081] In some embodiments, Fig.17 As shown, the positioning member 24 includes a first pull rod 242 and a second pull rod 243. The first pull rod 242 and the second pull rod 243 are both bent and wavy. The first end of the first pull rod 242 and the first end of the second pull rod 243 are an integrated structure and form a first connecting rod 244. The second end of the first pull rod 242 and the second end of the second pull rod 243 are an integrated structure and form a second connecting rod 245. The second connecting rod 245 is provided with a first wire hole 241. The first connecting rod 244 is fixed to the control bracket 21, and the second connecting rod 245 cooperates with the skirt 12.

[0082] When the artificial heart valve device 100 is located in the conveying mechanism 4, the second end of the positioning member 24 is against the inner wall of the sheath, the positioning member 24 is in a stretched state, and the bending degree of the first pull rod 242 and the second pull rod 243 is reduced; when the artificial heart valve device 100 is released, the control bracket 21 drives the positioning member 24 to move, and the positioning member 24 contracts, and drives the top of the skirt 12 to move, further expanding the diameter of the top of the skirt 12.

[0083] Preferably, there are a plurality of intersections 246 between the first pull rod 242 and the second pull rod 243, and a telescopic hole 247 is formed between two adjacent intersections 246. Specifically, the telescopic hole 247 facilitates the shape change of the positioning member 24 when the positioning member 24 is stretched or contracted.

[0084] In some embodiments, Fig.14 and Fig.15 As shown, the control bracket 21 has a plurality of control ends 211 and a third connection end 212, and the artificial heart valve device 100 also has a transmission member 25. The plurality of control ends 211 and the plurality of third connection ends 212 are arranged oppositely and staggered, the first end of the positioning member 24 is mounted on the third connection end 212, the first end of the transmission member 25 is fixed to the third connection end 212, and the second end of the transmission member 25 is fixed to the main body 22. Specifically, the plurality of control ends 211 are moved toward the center of the artificial heart valve device 100 by toggling, and the control bracket 21 will drive the plurality of transmission members 25 to move closer to each other through the plurality of third connection ends 212, and drive the main body 22 to close, and the transmission member 25 is used to transmit the force of the control bracket 21 to make the main body 22 expand or close.

[0085] In addition, the third connecting end 212 has a second wire hole 248 , and the second wire hole 248 is used for allowing the first end of the pull wire 3 to pass through and be fixed on the third connecting end 212 .

[0086] Preferably, Fig.15 As shown, the transmission member 25 includes a first support rod 251 and a second support rod 252. The first ends of the first support rod 251 and the second support rod 252 are fixed to the third connection end 212 of the control bracket 21, and the first ends of the first support rod 251 and the second support rod 252 are arranged far apart; the second ends of the first support rod 251 and the second support rod 252 are fixed to the main body 22, and the second ends of the first support rod 251 and the second support rod 252 are arranged close to each other. Specifically, when the control end 211 is radially close to the control bracket 21, the plurality of third connection ends 212 are driven to move, and the first end of the first support rod 251 and the first end of the second support rod 252 are driven to close. At this time, the first support rod 251 and the second support rod 252 drive the main body 22 to close, so that the artificial heart valve device 100 can be installed in the conveying mechanism 4. When the artificial heart valve device 100 is delivered to a preset position and in a corresponding temperature environment, the valve stent 2 unfolds, the diameters of the control stent 21 and the main body 22 increase, and drive the multiple third connecting ends 212 to move, the first end of the first support rod 251 and the first end of the second support rod 252 move away from each other, and the first support rod 251 and the second support rod 252 support the control stent 21.

[0087] In addition, if Figure 5 and Fig.15As shown, the main body 22 includes multiple first support rods 221 and second support rods 222. The multiple first support rods 221 and the multiple second support rods 222 are parallel and cross-arranged, and the multiple first support rods 221 and the multiple second support rods 222 form a grid structure. One of the first support rods 221 is fixed to the first support rod 251, and one of the second support rods 222 is fixed to the second support rod 252. The first support rod 251 and the first support rod 221 and the second support rod 252 and the second support rod 222 form a lever structure. When the first support rod 251 and the second support rod 252 move, the first support rod 221 and the second support rod 222 are driven to move, and the closing of the main body 22 is achieved.

[0088] The present invention also provides a method for implanting an artificial heart valve device 100, comprising the following steps:

[0089] Step 1: Install the artificial heart valve device 100 in the conveying mechanism 4, and the artificial heart valve device 100 is in a closed state;

[0090] Step 2: The conveying mechanism 4 conveys the artificial heart valve device 100 to a preset position, where the temperature is between 35 and 38 degrees Celsius, and the first sheath tube 41 of the conveying mechanism 4 releases the control stent 21;

[0091] Step 3: Control the stent 21 to drive the artificial valve 11 to unfold, and drive the first end of the positioning member 24 to move, and the second end of the positioning member 24 drives the top of the skirt 12 to unfold;

[0092] Step 4: The second sheath tube 42 of the conveying mechanism 4 releases the main body 22 , and the main body 22 opens the skirt 12 . The diameter of the top of the skirt 12 is greater than the diameter of the waist of the skirt 12 .

[0093] The implantation method of the artificial heart valve device 100 has different implantation forms according to the installation position, as follows:

[0094] Figure 7Schematic diagram of the state of the artificial heart valve device 100 implanted at a high position, the position of the positioning member 24 is higher than the top of the native valve 51, and in some positions where calcification is more serious, there will be a gap 52 between the native valve 51 and the artificial valve 11. According to the conventional design, the skirt 12 is attached to the valve support 2, and the skirt 12 cannot cover the gap 52, and blood easily flows back from the aorta to the left ventricle through the gap 52, resulting in paravalvular leakage. In this embodiment, since the skirt 12 is a floating design, and the top of the skirt 12 is fixedly set at the second end of the positioning member 24, when the left ventricle is diastolic, the artificial valve 11 is closed, and blood flows from the aorta to the left ventricle, but the artificial valve 11 is closed to intercept blood to the aortic sinus 6, and the blood flow pushes the top of the skirt 12, so that the top of the skirt 12 is unfolded to form a seal for the gap 52. This artificial valve 11 or skirt 12 is equivalent to a one-way valve to ensure one-way blood flow. The sealing effect of the skirt 12 between the positioning member 24 and the top of the native valve 51 is similar to the axial sealing mechanism.

[0095] Fig.10 It is a schematic diagram of the state of the artificial heart valve device 100 being implanted at a low position. During the low position implantation, blood flow acts on the skirt 12 during diastole, and the expanded skirt 12 can seal the gap 52. At the same time, due to the larger contact area between the left ventricular outflow tract 5 and the skirt 12 during the low position implantation, it is easier to complete the sealing.

[0096] Fig.11 This is a schematic diagram of the state of the artificial heart valve device 100 being implanted out of axis. When the valve stent 2 and the native valve 51 are not in the same axis, it has been explained above that the floating seal can perform a sealing function at both the high and low positions. Therefore, even when they are implanted out of axis, with one side in the high position and the other side in the low position, the artificial heart valve device 100 can still complete the sealing.

[0097] When quoting drawing descriptions, new features that appear are described; in order to avoid repeated quotations of drawings resulting in less concise descriptions, features that have been described clearly will not be quoted in the drawings one by one.

[0098] 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.

[0099] 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 heart valve device, characterized in that: include: A valve stent, a skirt, and an artificial valve, wherein the valve stent comprises a control stent, a main body, and at least three positioning members, wherein the artificial valve is mounted on the control stent, the skirt is sleeved outside the main body, and the first end of the positioning member is fixed to the control stent, and the second end of the positioning member is matched with the top of the skirt; Among them, three positioning members are distributed in the circumferential direction of the valve stent, and the three positioning members are used to support the top of the skirt; when the valve stent is in a natural state, the diameter of the top of the skirt is greater than the diameter of the waist of the skirt.

2. The artificial heart valve device according to claim 1, characterized in that: The number of the positioning elements is at least four, and the four positioning elements are equidistantly arranged along the circumference of the valve stent.

3. The artificial heart valve device according to claim 1, characterized in that: The positioning member has a first wire hole, the valve support also has a pull wire, and the skirt also has a first connecting end and a second connecting end; the first end of the pull wire is fixed to the control support, and the second end of the pull wire passes through the first connecting end, the first wire hole, the second connecting end in sequence, and is fixed to the skirt.

4. The artificial heart valve device according to claim 3, characterized in that: The first connecting end and the second connecting end are arranged along the axial center line direction of the skirt; on one side of the skirt, a surplus portion is formed between the first connecting end and the second connecting end; When the valve stent is in a folded state, the surplus portion is in a folded state; when the valve stent is in an expanded state, the surplus portion is in an expanded state.

5. The artificial heart valve device according to claim 4, characterized in that: The pull wire has an extension section, and the length of the extension section when the valve stent is in a closed state is smaller than the length of the extension section when the valve stent is in an expanded state.

6. The artificial heart valve device according to claim 3, characterized in that: At least a portion of the positioning member is in a bent wave shape.

7. The artificial heart valve device according to claim 6, characterized in that: The positioning member includes a first pull rod and a second pull rod, the first pull rod and the second pull rod are both in a bent wave shape, the first end of the first pull rod and the first end of the second pull rod are an integrated structure and form a first connecting rod, the second end of the first pull rod and the second end of the second pull rod are an integrated structure and form a second connecting rod, and the second connecting rod is provided with a first wire hole; The first connecting rod is fixed to the control bracket, and the second connecting rod is matched with the skirt.

8. The artificial heart valve device according to any one of claims 1 to 7, characterized in that: The control bracket has multiple control ends and a third connecting end, and the artificial heart valve device also has a transmission member. The multiple control ends are opposite to and staggered with the multiple third connecting ends. The first end of the positioning member is installed on the third connecting end, the first end of the transmission member is fixed to the third connecting end, and the second end of the transmission member is fixed to the main body.

9. The artificial heart valve device according to claim 8, characterized in that: The transmission member includes a first support rod and a second support rod, wherein the first ends of the first support rod and the second support rod are fixed to the third connecting end of the control bracket, and the first ends of the first support rod and the second support rod are arranged far apart; the second ends of the first support rod and the second support rod are fixed to the main body, and the second ends of the first support rod and the second support rod are arranged close to each other.

10. A method for implanting an artificial heart valve device, characterized in that: The following steps are involved: Installing the artificial heart valve device in the delivery mechanism, wherein the artificial heart valve device is in a closed state; The delivery mechanism delivers the artificial heart valve device to a preset position, and the first sheath of the delivery mechanism releases the control stent; The control stent drives the artificial valve to unfold, and drives the first end of the positioning member to move, and the second end of the positioning member drives the top of the skirt to unfold; The second sheath tube of the conveying mechanism releases the main body, and the main body stretches the skirt, and the diameter of the top of the skirt is greater than the diameter of the waist of the skirt.

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