Artificial heart valve device and implantation method thereof

Abstract

This invention discloses an artificial heart valve device and its implantation method, belonging to the technical field of medical devices. The device includes a valve stent, a skirt, and an artificial valve. The valve stent comprises a control stent, a main body, and at least three positioning members. The artificial valve is mounted on the control stent, and the skirt is fitted over the main body. The first end of each positioning member is fixed to the control stent, and the second end of each positioning member engages with the top of the skirt. The three positioning members are distributed circumferentially on the valve stent and support the top of the skirt. In its natural state, the diameter of the top of the skirt is larger than the diameter of the waist of the skirt. The three positioning members unfold the top of the skirt, forming a funnel shape, which pushes the delivery mechanism towards the left ventricle. This ensures that the top of the skirt abuts against the autologous valve, forming a sealing area between the top of the skirt and the autologous valve. This sealing area helps prevent paravalvular leakage.

Description

Technical Field

[0001] This invention relates to the technical field of medical devices, and in particular to an artificial heart valve device and its implantation method. Background Technology

[0002] Valvular heart disease is a common condition, and its incidence increases with age. Currently, the usual treatment for this disease is surgical replacement of the diseased valve. However, this method is not suitable for some elderly patients or those with comorbidities. For these patients, a minimally invasive approach can be used to replace the heart valve with an artificial one.

[0003] Transcatheter artificial heart valve products are mainly divided into two types: balloon-expandable valves and self-expanding valves. In self-expanding valves, the valve is first radially compressed and then placed inside the sheath of the delivery mechanism. The sheath, carrying the compressed valve, is inserted from the blood vessel into the location of the heart lesion. Then, using the handle of the delivery mechanism, the self-expanding valve is fixed and the sheath is retracted relative to the valve, thereby achieving the effect of valve release. However, existing valves are prone to paravalvular leakage after release. Summary of the Invention

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

[0005] The technical solutions for achieving the above objectives include the following:

[0006] Artificial heart valve devices include:

[0007] A valve stent, a skirt, and an artificial valve. The valve stent includes a control stent, a main body, and at least three positioning elements. The artificial valve is installed on the control stent. The skirt is fitted over the main body, and the first end of the positioning element is fixed to the control stent, while the second end of the positioning element engages with the top of the skirt.

[0008] Three positioning members are distributed circumferentially on the valve stent, and the three positioning members are used to support the top of the skirt; in the natural state, the diameter of the top of the skirt is larger than the diameter of the waist of the skirt.

[0009] In one embodiment, the number of 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 stent 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 bracket, and the second end of the pull wire passes through the first connecting end, the first wire hole, and 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 axis of the skirt; on one side of the skirt, a spare portion is formed between the first connecting end and the second connecting end;

[0012] When the valve stent is in the closed state, the excess portion is folded; when the valve stent is in the unfolded state, the excess portion is unfolded.

[0013] In one embodiment, the pull wire has an extension section, the length of which is less than ...

[0014] In one embodiment, the positioning element is at least partially bent in a wavy shape.

[0015] In one embodiment, the positioning member includes a first pull rod and a second pull rod. Both the first pull rod and the second pull rod are bent in a wavy shape. The first end of the first pull rod and the first end of the second pull rod are integrally formed to form a first connecting rod. The second end of the first pull rod and the second end of the second pull rod are integrally formed to form a second connecting rod. The second connecting rod has a first wire hole.

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

[0017] In one embodiment, the control bracket has multiple control ends and a third connection end, the artificial heart valve device also has a transmission component, the multiple control ends and the multiple third connection ends are opposite to and staggered, the first end of the positioning component is mounted on the third connection end, the first end of the transmission component is fixed to the third connection end, and the second end of the transmission component is fixed to the main body.

[0018] In one embodiment, the transmission component includes a first support rod and a second support rod. The first ends of both the first and second support rods are fixed to the third connecting end of the control bracket, and the first ends of the first and second support rods are positioned far apart from each other. The second ends of both the first and second support rods are fixed to the main body, and the second ends of the first and second support rods are positioned close to each other.

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

[0020] Step 1: Install the artificial heart valve device into the delivery mechanism; the artificial heart valve device is in the closed position.

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

[0022] Step 3: The control stent drives the artificial valve to unfold and moves the first end of the positioning component, while the second end of the positioning component drives the top of the skirt to unfold.

[0023] Step 4: The second sheath of the conveying mechanism releases the main body, which then opens the skirt. The diameter of the top of the skirt is larger than the diameter of the waist of the skirt.

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

[0025] When the delivery mechanism transports the artificial heart valve device to the preset position, the first sheath of the delivery mechanism releases first, and the control stent unfolds at the preset position. The control stent moves the three positioning components, which unfold the top of the skirt so that the diameter of the top of the skirt is larger than the diameter of the waist of the skirt, forming a funnel shape. At this time, the delivery mechanism can be pushed towards the left ventricle, ensuring that the top of the skirt abuts against the autologous valve, thus positioning the artificial heart valve device. Simultaneously, a sealing zone is formed between the top of the skirt and the autologous valve. This sealing zone prevents paravalvular leakage and makes the artificial heart valve device more stable axially in the left ventricular outflow tract. Attached Figure Description

[0026] The accompanying drawings illustrate specific examples of the technical solutions described in this invention and, together with the detailed embodiments, form part of the specification, serving to explain the technical solutions, principles, and effects of this invention.

[0027] Unless otherwise specified or defined, the same reference numerals in different figures represent the same or similar technical features, and different reference numerals may be used to represent the same or similar technical features.

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

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

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

[0031] Figure 4 This is a schematic diagram showing the position between the positioning element and the autologous valve in one embodiment of the present invention;

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

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

[0034] Figure 7 This is a schematic diagram showing the unfolded state of the artificial heart valve device after implantation in one embodiment of the present invention;

[0035] Figure 8 This is a schematic diagram illustrating the combination of an artificial heart valve device and an autologous valve in one embodiment of the present invention. Figure 1 ;

[0036] Figure 9 This is a schematic diagram illustrating the combination of an artificial heart valve device and an autologous valve in one embodiment of the present invention. Figure 2 ;

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

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

[0039] Figure 12 This is a schematic diagram of the pull wire after the artificial heart valve device contracts in one embodiment of the present invention;

[0040] Figure 13 This is a schematic diagram of the pull wire of the artificial heart valve device after it has been deployed in one embodiment of the present invention;

[0041] Figure 14 This is a schematic diagram of a control bracket in one embodiment of the present invention. Figure 1 ;

[0042] Figure 15 This is a schematic diagram of a control bracket in one embodiment of the present invention. Figure 2 ;

[0043] Figure 16 This is a schematic diagram of a positioning element in one embodiment of the present invention;

[0044] Figure 17 This is a schematic diagram of the cooperation between the pull wire and the positioning component in one embodiment of the present invention;

[0045] Explanation of reference numerals in the attached figures:

[0046] 100. Artificial heart valve device;

[0047] 11. Artificial valve; 12. Skirt; 121. First connecting end; 122. Second connecting end; 123. Excess portion; 13. Suture edge;

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

[0049] 25. Transmission component; 251. First support rod; 252. Second support rod;

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

[0051] 4. Conveying mechanism; 41. First sheath; 42. Second sheath;

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

[0053] 6. Aortic sinus. Detailed Implementation

[0054] To facilitate 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 terms "first," "second," etc., used in this document are for distinguishing names only and do not represent a specific number or order.

[0056] Unless otherwise stated or defined, 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 "fixed" to another component, it can be directly fixed to the other component or there can be an intervening component; when a component is considered "connected" to another component, it can be directly connected to the other component or there can be an intervening component; when a component is considered "mounted" on another component, it can be directly mounted on the other component or there can be an intervening component; when a component is considered "placed" on another component, it can be directly placed on the other component or there can be an intervening component.

[0058] Example 1

[0059] Studies have found that a common cause of paravalvular leakage in self-expanding artificial heart valves with protrusions is that, during actual operation, the artificial valve, after being released via catheter, is not coaxial with the native valve or is implanted too deeply (the protrusion is located within the native valve). Protrusions on the stent may be located within the calcification level of the native valve after release in one or more places. Due to the self-expanding effect of the stent in the body, the protrusion exerts a certain force on the calcification of the native valve. Calcified valves are usually quite rigid and cannot conform to the contour of the stent locally, thus creating a gap between the stent and the calcified valve. When the left ventricle contracts, the artificial valve opens, and blood from the left ventricle flows to the aorta; when the left ventricle relaxes, the artificial valve closes, and blood can easily flow back into the left ventricle through this gap, resulting in paravalvular leakage.

[0060] This embodiment proposes 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 bracket 21, a main body 22, and at least three positioning members 24. The artificial valve 11 is installed on the control bracket 21. The skirt 12 is sleeved on the main body 22, and the first end of the positioning member 24 is fixed to the control bracket 21, and the second end of the positioning member 24 cooperates with the top of the skirt 12. The three positioning members 24 are distributed in the circumferential direction of the valve stent 2 and are used to support the top of the skirt 12. In the natural state, the diameter of the top of the skirt 12 is larger 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 initiation point of the positioning member 24 is located at a high position in the artificial heart valve device 100. When the artificial heart valve device 100 is delivered, when the artificial valve 11 is delivered to the aortic sinus 6, the first sheath 41 is released first. After the control bracket 21 is deployed, it can drive the positioning member 24 to be deployed. The second end of the positioning member 24 forms an anchor point between itself and the top of the skirt 12. This anchor point abuts against the autologous valve 51, thereby achieving the positioning function of the artificial heart valve device 100 and improving the vertical stability between the artificial heart valve device 100 and the autologous valve 51. Because three positioning elements 24 are used to engage with the top of the skirt 12, and the three positioning elements 24 are distributed circumferentially on the valve stent 2, regardless of whether the artificial heart valve device 100 is in a high position or whether it is coaxial or non-coaxial with the aortic sinus 6, at least one positioning element 24 can be ensured to drive the top of the skirt 12 to unfold, so that the top of the skirt 12 forms an anchor point with the autologous valve 51, thereby improving the fault tolerance rate of the artificial heart valve device 100 in installation and positioning.

[0062] Furthermore, as long as the operator follows the operating procedures, the artificial heart valve device 100 can be positioned high, coaxially with, or non-coaxially with the aortic sinus 6. Operationally, there is no difficulty in implanting the artificial heart valve device 100 high, coaxially with, or non-coaxially with the aortic sinus 6. Therefore, the anchoring and sealing effect of the artificial heart valve device 100 in this embodiment is superior to that of conventional valves. Of course, if the artificial heart valve device 100 is implanted too low, the positioning element 24 may be entirely within the autologous valve 51, and the top of the skirt 12 may not be able to be opened by the positioning element 24. However, the skirt 12 can still function as a normal valve, and its anchoring function is equivalent to that of a normal cylindrical self-expanding valve. It should be noted that low implantation is related to improper operation by 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, with a junction point 53 between adjacent native leaflets. This embodiment focuses on the application scenario of the valve stent 2 in a three-native-leaflet configuration. The artificial valve 11 includes three artificial leaflets, with a suture edge 13 between them. The control stent 21 has a suture bar 23, on which multiple suture holes are provided longitudinally for fixing the artificial leaflets. The artificial valve 11 is equivalent to the aortic valve in the human body. When the left ventricle contracts, the artificial valve 11 opens, allowing blood to flow from the left ventricle into the aorta; when the left ventricle relaxes, the artificial valve 11 closes to prevent blood from flowing back into 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, and the control bracket 21 unfolds at the preset position. The control bracket 21 drives the three positioning members 24 to move, and the three positioning members 24 unfold the top of the skirt 12, making the diameter of the top of the skirt 12 larger than the diameter of the waist of the skirt 12. After unfolding, the top of the skirt 12 is funnel-shaped. At this time, the delivery mechanism 4 can be pushed towards the left ventricle, which ensures that the top of the skirt 12 abuts against the autologous valve 51, thus 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 autologous valve 51. With the help of this 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 element 24 unfolds the top of the skirt 12, the second sheath 42 is released, allowing the main body 22 to unfold within the left ventricular outflow tract 5 and the anatomical structures above it, and opening up the waist and bottom of the skirt 12.

[0066] It can be further understood that when the positioning element 24 unfolds the top of the skirt 12, an anchoring point is formed between the skirt 12 and the autologous valve 51. This anchoring point is along the axis of the skirt 12, causing the artificial heart valve device 100 to abut against the autologous valve 51, thus improving the stability of the skirt 12. Furthermore, the skirt 12 has a certain degree of elasticity, which also allows for flexible contact between the skirt 12 and the autologous valve 51. When the left ventricle is in diastole, the artificial valve 11 closes to prevent blood from flowing back into the left ventricle. Moreover, the blood flows back to the top of the skirt 12 and acts on it again, causing the top of the skirt 12 to bend, increasing the contact area between the top of the skirt 12 and the autologous valve 51. A larger sealing area is formed between the skirt 12 and the autologous valve 41, preventing blood from flowing back into the left ventricle. When the left ventricle contracts, the artificial valve 11 opens, and blood from the left ventricle flows into the aorta. The blood has a certain flow velocity, and the force generated by the blood flowing into the aorta will push the gap 52 between the skirt 12 and the autologous valve 51 to open, further increasing the opening area of ​​the artificial valve 11 and increasing the flow rate of blood into the aorta.

[0067] Furthermore, the three positioning elements 24 are distributed circumferentially on the valve stent 2. These three elements support the top of the skirt 12. The probability of the three positioning elements 24 being located at the junction 53 of the autologous valve 51 is very small; generally, at least one positioning element 24 is located outside the junction 53 of the autologous valve 51. This positioning element 24 will hook onto the top of the skirt 12, causing the top of the skirt 12 to abut against the autologous valve 51, forming a sealing area between the top of the skirt 12 and the autologous valve 51. Therefore, providing three positioning elements 24 can increase the fault tolerance of the artificial heart valve device 100, greatly improving its practicality.

[0068] Furthermore, in existing technologies, the protrusion (positioning) structure is primarily installed within the main body 22. During release, due to the limited unfolding of the main body 22, the protrusion structure cannot unfold to its maximum extent. Therefore, it is difficult to utilize the mutual resistance between the protrusion structure and the autologous valve 51 during release, making it difficult to achieve the positioning function. Due to the poor positioning effect, the protrusion structure cannot be guaranteed to be placed above the autologous valve 51. When the protrusion structure is placed inside or below the autologous valve, the reaction force from the calcified leaflet will cause the protrusion structure to deform, thereby exerting inward pressure on the main body 22 that initiated the protrusion structure, resulting in deformation and a reduction in the opening area of ​​the artificial valve 11 installed in the main body 22. In this embodiment, the positioning element 24 is initiated within the control bracket 21. After the first sheath 41 is retracted, the positioning element 24 can unfold to a great extent, facilitating positioning. Since the positioning element 24 is mounted on the control bracket 21 and has a good unfolding function, the positioning element 24 can be placed above the autologous valve 51. Therefore, the reaction force from the calcified leaflet will not have an additional morphological effect due to the presence of the positioning element 24. Thus, in this embodiment, the installation position of the positioning element 24 has no effect on the opening area of ​​the artificial valve 11.

[0069] Furthermore, if the artificial heart valve device 100 is implanted too low, the positioning element 24 is located inside the autologous valve 51. The positioning element 24 is compressed by calcification, and its initiation position is located on the control stent 21. Moreover, the stiffness of the control stent 21 differs greatly from that of the main body 22. That is, the limited deformation of the control stent 21 cannot affect the overall shape of the main body 22.

[0070] Preferably, there are four positioning elements 24, which are equidistantly arranged along the circumference of the valve stent 2. Specifically, when there are four positioning elements 24, at most one of them may be positioned at the junction 53 of the autologous valve 51; ensuring that three positioning elements 24 are staggered from the junction 53 of the autologous valve 51, so that the top of the skirt 12 has at least three contact points located axially in the left ventricular outflow tract 5, further improving the axial stability of the artificial heart valve device 100 after implantation. Furthermore, a large sealing area exists between the autologous valve 51 and the skirt 12, further preventing paravalvular leakage.

[0071] Preferred, such as Figure 3 and Figure 4As shown, there are six positioning elements 24, which can be equidistantly arranged along the circumference of the valve stent 2. If three positioning elements 24 are located at the junction 53 of the autologous valve 51, the remaining three positioning elements 24 are located between the autologous valve 51 and the aortic sinus 6. This controls the stent 21 to unfold, thereby unfolding the remaining three positioning elements 24 and expanding the area of ​​the top of the skirt 12. This makes the diameter of the top of the skirt 12 larger than the diameter of the waist of the skirt 12, thus forming a larger sealing area and further improving the anti-valvular leakage performance.

[0072] Example 2

[0073] To ensure that, after implantation of the artificial heart valve device 100, the top of the skirt 12 has sufficient slack to contact or hang on the top of the autologous 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 stent 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 bracket 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 is sequentially threaded through the first connecting end 121, the first wire hole 241, and the second connecting end 122 before being fixed to the skirt 12. For example... Figure 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; as Figure 12 As shown, when the artificial heart valve device 100 is in the closed state, the position between the first connecting end 121 and the second connecting end 122 on the skirt 12 is folded, and the top of the skirt 12 has a certain amount of excess space, 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 excess portion 123 at the top of the skirt 12 to unfold. The blood flow has a certain velocity and pushes the gap 52 between the top of the skirt 12 and the autologous valve 51 to open, increasing the opening area of ​​the artificial valve 11.

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

[0076] Preferred, such as Figure 12 and Figure 13 As shown, the first connecting end 121 and the second connecting end 122 are distributed along the axis of the skirt 12; on one side of the skirt 12, a surplus portion 123 is formed between the first connecting end 121 and the second connecting end 122; when the valve stent 2 is in the closed state, the surplus portion 123 is folded; when the valve stent 2 is in the unfolded state, the surplus portion 123 is unfolded. Specifically, when the valve stent 2 is unfolded, the top of the skirt 12 has a sufficient portion for the positioning member 24 to lift or move. After the surplus portion 123 is moved, it is unfolded. Under the action of the positioning member 24, the top diameter of the skirt 12 is larger than the diameter of the waist of the skirt 12, and the top of the skirt 12 forms a larger sealing area.

[0077] Preferred, such as Figure 12 and Figure 13 As shown, the pull wire 3 has an extension section 31, and the length of the extension section 3 in the closed state of the valve stent 2 is less than the length of the extension section 3 in the deployed state of the valve stent 2. Specifically, as... Figure 16 As shown, in its natural state, the positioning member 24 can be considered a quadrilateral with four sides A, B, C, and D. During the insertion of the artificial heart valve device 100 into the sheath, the lengths of A, B, C, and D remain essentially unchanged, but the angle between A and B decreases, and the angle between C and D decreases. Therefore, the length of the diagonal L between the two angles increases. Since the length of the pull wire 3 is fixed, when the diagonal L increases, the pull wire 3 will lift the fixing point P on the skirt 12, and the skirt 12 will form a fold (excess portion 123) below the positioning member 24; in this embodiment, this fixing point P is the fixing end 32 of the pull wire 3.

[0078] When the artificial heart valve device 100 is released, the skirt 12 has a folding allowance 123 reserved below the positioning member 24, which facilitates better expansion of the positioning member 24. The top of the skirt 12 is driven by the positioning member 24 to unfold, which facilitates the overall positioning and sealing of the artificial heart valve device 100. Figure 13 In its natural state, the tension line 3 is relatively loose, and the fixing point P of the skirt hem 12 is not under stress; as Figure 12 When the sheath is retracted, the fixed point P is subjected to tension from the pull wire 3, forming a wrinkle.

[0079] In some embodiments, the positioning element 24 is at least partially bent and wavy. Specifically, because the elastic modulus of the pull wire 3 is relatively large, when the first sheath 41 is released, the control bracket 21 drives the first end of the positioning element 24 to move, and the control bracket 21 also drives the pull wire 3 to move when it moves. The positioning element 24 is bent and wavy, and the positioning element 24 is generally made of metal. The elastic modulus of the positioning element 24 is relatively small, and the positioning element 24 has a certain degree of elasticity. The positioning element 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 fit between the pull wire 3 and the top of the skirt 12.

[0080] Furthermore, when the artificial valve 11 retracts, the folding of the control stent 21 generates a pulling force on the suture 3. The skirt 12, under the pulling force from the fixed end 32, moves closer to the first connecting end 121, forming a pleated excess portion 123. During this process, the first connecting end 121 will impede the movement of the suture 3, i.e., the first connecting end 121 will experience frictional resistance from the suture 3. Setting the positioning member 24 in a wave-like shape helps to buffer this frictional resistance, preventing excessive pulling of the suture 3 by the first connecting end 121. Relying on this buffering effect, excessive pulling of the top of the skirt 12 by the suture 3 can also be prevented, thereby improving the stability of the fit between the suture 3 and the top of the skirt 12.

[0081] In some embodiments, such as Figure 17 As shown, the positioning component 24 includes a first pull rod 242 and a second pull rod 243. Both the first pull rod 242 and the second pull rod 243 are bent in a wave shape. The first end of the first pull rod 242 and the first end of the second pull rod 243 are integrally formed to 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 integrally formed to form a second connecting rod 245. The second connecting rod 245 has 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 delivery mechanism 4, the second end of the positioning member 24 abuts against the inner wall of the sheath, the positioning member 24 is stretched, 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 stent 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, the first pull rod 242 and the second pull rod 243 have multiple intersection points 246, and an expansion hole 247 is formed between two adjacent intersection points 246. Specifically, the expansion hole 247 facilitates the positioning member 24 to meet the shape changes of the positioning member 24 when it is stretched or contracted.

[0084] In some embodiments, such as Figure 14 and Figure 15 As shown, the control stent 21 has multiple control ends 211 and third connecting ends 212. The artificial heart valve device 100 also has a transmission component 25. The multiple control ends 211 and the multiple third connecting ends 212 are arranged opposite to and staggered. The first end of the positioning component 24 is installed on the third connecting end 212. The first end of the transmission component 25 is fixed to the third connecting end 212, and the second end of the transmission component 25 is fixed to the main body 22. Specifically, by moving the multiple control ends 211, the multiple control ends 211 move toward the center of the artificial heart valve device 100. The control stent 21 will drive the multiple transmission components 25 to move closer to each other through the multiple third connecting ends 212, and drive the main body 22 to close. The transmission component 25 is used to transmit the force of the control stent 21, so that the main body 22 unfolds or closes.

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

[0086] Preferred, such as Figure 15 As shown, the transmission component 25 includes a first support rod 251 and a second support rod 252. The first ends of both the first support rod 251 and the second support rod 252 are fixed to the third connecting end 212 of the control bracket 21, and the first ends of the first support rod 251 and the second support rod 252 are positioned far apart from each other. The second ends of both 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 positioned close to each other. Specifically, when the control end 211 moves radially closer to the control bracket 21, it drives multiple third connecting ends 212 to move, and drives the first ends of the first support rod 251 and the first ends of the second support rod 252 to move closer together. 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 delivery mechanism 4. When the artificial heart valve device 100 is delivered to the preset position and in the corresponding temperature environment, the valve stent 2 unfolds, the diameter of the control stent 21 and the main body 22 increases, and multiple third connection ends 212 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, such as Figure 5 and Figure 15As shown, the main body 22 includes multiple first support rods 221 and second support rods 222. The multiple first support rods 221 and multiple second support rods 222 are arranged parallel to each other and intersecting each other. The multiple first support rods 221 and 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 rods 251 and the first support rods 221, as well as the second support rods 252 and the second support rods 222, form a lever structure. When the first support rods 251 and the second support rods 252 move, they drive the first support rods 221 and the second support rods 222 to move, thereby achieving the closing of the main body 22.

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

[0089] Step 1: Install the artificial heart valve device 100 into the delivery mechanism 4, with the artificial heart valve device 100 in a closed state;

[0090] Step 2: The delivery mechanism 4 delivers the artificial heart valve device 100 to a preset position. The temperature of the preset position is between 35 and 38 degrees Celsius. The first sheath 41 of the delivery mechanism 4 releases the control stent 21.

[0091] Step 3: The control bracket 21 drives the artificial valve 11 to unfold, and drives the first end of the positioning component 24 to move. The second end of the positioning component 24 drives the top of the skirt 12 to unfold.

[0092] Step 4: The second sheath 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 this artificial heart valve device 100 varies depending on the implantation location, as detailed below:

[0094] Figure 7This diagram illustrates the high-position implantation of the artificial heart valve device 100. The positioning element 24 is positioned above the top of the autologous valve 51. In areas with severe calcification, a gap 52 may exist between the autologous valve 51 and the artificial valve 11. In conventional designs, the skirt 12 rests against the valve stent 2, but it cannot cover the gap 52, allowing blood to easily flow back from the aorta to the left ventricle, resulting in paravalvular leakage. In this embodiment, because the skirt 12 is a floating design, and its top is fixedly positioned at the second end of the positioning element 24, when the left ventricle relaxes, the artificial valve 11 closes, allowing blood to flow from the aorta to the left ventricle. However, the closure of the artificial valve 11 also diverts blood flow to the aortic sinus 6. The blood flow pushes the top of the skirt 12, causing it to unfold and seal the gap 52. This artificial valve 11 or skirt 12 acts as a one-way valve, ensuring unidirectional blood flow. The sealing effect of the skirt 12 between the positioning element 24 and the tip of the autologous valve 51 is similar to that of axial sealing.

[0095] Figure 10 This is a schematic diagram of the low-position implantation of the artificial heart valve device 100. In low-position implantation, diastolic blood flow acts on the skirt 12, and the expanded skirt 12 can seal the gap 52. At the same time, because the contact area between the left ventricular outflow tract 5 and the skirt 12 is larger under low-position implantation, it is easier to complete the seal.

[0096] Figure 11 This is a schematic diagram of the implantation of the artificial heart valve device 100 in a non-axial state. When the valve stent 2 and the autologous valve 51 are non-axial, as explained above, the floating seal can play a sealing role in both high and low positions. Therefore, even when implanted in a non-axial state, with one side in a high position and the other side in a low position, the artificial heart valve device 100 can still achieve a seal.

[0097] When referencing drawings, new features are explained. To avoid redundant references to drawings that would make the description less concise, features already described will not be referenced again on the drawings if the description is clear.

[0098] The purpose of the above embodiments is to reproduce and derive the technical solution of the present invention by way of example, and to fully describe the technical solution, purpose and effect of the present invention. The purpose is to enable the public to have a more thorough and comprehensive understanding of the disclosure of the present invention, and not to limit the scope of protection of the present invention.

[0099] The above embodiments are not an exhaustive list based on the present invention, and there may be many other embodiments not listed. Any substitutions and improvements made without departing from the concept of the present invention are 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. The valve stent includes a control stent, a main body, and at least three positioning elements. The bottom of the control stent is connected to the top of the main body. The artificial valve is installed on the control stent. The skirt is fitted over the main body, and the first end of each positioning element is fixed to the control stent, while the second end of each positioning element engages with the top of the skirt. Three positioning members are distributed circumferentially on the valve stent, and the three positioning members are used to support the top of the skirt; in the natural state, the diameter of the top of the skirt is larger than the diameter of the waist of the skirt.

2. The artificial heart valve device as described in claim 1, characterized in that, The number of 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 as described in claim 1, characterized in that, The positioning element has a first wire hole, the valve stent 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 bracket, and the second end of the pull wire passes through the first connecting end, the first wire hole, and the second connecting end in sequence, and is fixed to the skirt.

4. The artificial heart valve device as described in claim 3, characterized in that, The first connecting end and the second connecting end are distributed along the axis of the skirt; on one side of the skirt, a spare portion is formed between the first connecting end and the second connecting end; When the valve stent is in a closed state, the excess portion is folded; when the valve stent is in an unfolded state, the excess portion is unfolded.

5. The artificial heart valve device as described in claim 4, characterized in that, The pull wire has an extension section, and the length of the extension section of the valve stent in the closed state is less than the length of the extension section of the valve stent in the deployed state.

6. The artificial heart valve device as described in claim 3, characterized in that, The positioning element is at least partially bent and wavy.

7. The artificial heart valve device as described in claim 6, characterized in that, The positioning component includes a first pull rod and a second pull rod. Both the first pull rod and the second pull rod are bent in a wave shape. The first end of the first pull rod and the first end of the second pull rod are integrally formed to form a first connecting rod. The second end of the first pull rod and the second end of the second pull rod are integrally formed to form a second connecting rod. The second connecting rod has a first wire hole. The first connecting rod is fixed to the control bracket, and the second connecting rod is engaged 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 connection end. The artificial heart valve device also has a transmission component. The multiple control ends and the multiple third connection ends are opposite to and staggered. The first end of the positioning component is installed on the third connection end. The first end of the transmission component is fixed to the third connection end. The second end of the transmission component is fixed to the main body.

9. The artificial heart valve device as described in claim 8, characterized in that, The transmission component includes a first support rod and a second support rod. The first ends of the first support rod and the second support rod are both 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 set far apart from each other. The second ends of the first support rod and the second support rod are both fixed to the main body, and the second ends of the first support rod and the second support rod are set close to each other.

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