A heart valve prosthesis

Abstract

The present invention provides a heart valve prosthesis, which is applied to the field of interventional medical prosthesis technology. In the heart valve prosthesis provided by the present invention, under the condition that the leaflet connecting parts have the same size, compared with the prior art in which a closed hole is set on the leaflet fixing structure, the embodiment of the present invention sets a plurality of leaflet connecting parts with a double-row hole structure in which each row of holes contains at least one non-closed hole in the stent body in the heart valve prosthesis, thereby achieving a larger number of suture holes with a more compact distribution on the leaflet fixing structure, increasing the connection points between the leaflet and the stent, and achieving the condition that the outer diameter of the stent does not increase after compression, thereby enhancing the connection strength between the leaflet and the stent, thereby improving the stability of the heart valve prosthesis in the working state.

Description

Technical Field

[0001] The invention relates to the technical field of interventional medical prostheses, and in particular to a heart valve prosthesis. Background Art

[0002] The heart contains four chambers. The left atrium and left ventricle are located on the left side of the heart, and the right atrium and right ventricle are located on the right side of the heart. The ventricular inflow tract structure is formed between the atrium and the ventricle, the left ventricle and the aorta form the left ventricular outflow tract structure, and the right ventricle and the pulmonary artery form the right ventricular outflow tract structure. There are valves with "one-way valve" functions in the ventricular inflow tract structure and the ventricular outflow tract structure to ensure the normal flow of blood in the heart chamber. When there is a problem with the valve, the heart's hemodynamics changes and the heart function is abnormal, which is called valvular heart disease.

[0003] With the extension of human life span and the aging of the population, the incidence of heart valve disease is getting higher and higher. According to literature statistics, 2% to 7% of the elderly over 65 years old have valvular disease. An artificial heart valve (Heart Valve Prothesis) is an artificial organ that can be implanted in the heart to replace the heart valves (including the aortic valve, pulmonary valve, tricuspid valve and mitral valve), which can make blood flow in one direction and has the function of a natural heart valve. When the heart valve lesions are severe and the valve separation surgery or repair surgery cannot be used to restore or improve the valve function, an artificial heart valve replacement must be used. Due to the complexity of interventional heart valve replacement, the design of interventional heart valves is very difficult. For example, in actual applications, artificial heart valves have certain requirements for the contact area of ​​the valve leaflets after closure and the connection stability of the valve leaflets and the stent.

[0004] However, in the prior art, the mechanical properties of the stent of the artificial heart valve for interventional surgery are relatively poor, which will affect the connection between the leaflets and the stent, resulting in the defect of poor connection stability between the leaflets and the stent, and thus making it easy for the artificial heart valve to shift under the impact of blood during normal operation of the artificial heart valve at the lesion position in the human body, so that when the heart valve is in a closed state, the contact area of ​​the valve leaflets is insufficient, and in severe cases, the artificial heart valve prosthesis fails. Furthermore, for the transcatheter heart valve system, the valve stent is compressed into the sheath of the delivery system, and the delivery of the valve stent is achieved by the axial movement of the sheath, so the outer diameter (profile) of the valve stent after compression needs to be slightly smaller than the inner diameter of the sheath. If only the number of connection holes between the leaflets and the stent in the prior art is increased, the outer diameter (profile) of the valve stent after compression will increase. Therefore, how to enhance the connection strength between the leaflets and the stent without increasing the outer diameter (profile) of the valve stent after compression is a problem to be solved urgently. Summary of the invention

[0005] The object of the present invention is to provide a heart valve prosthesis, so as to enhance the connection strength between the valve leaflets and the stent in the heart valve prosthesis without increasing the outer diameter of the stent in the heart valve prosthesis after compression.

[0006] In order to solve the above technical problems, the present invention provides a heart valve prosthesis, including a stent body and at least two leaflets connected to the stent body, the stent body including interconnected grid-like structural units from the inflow end to the outflow end, the stent body also including a plurality of leaflet fixing structures, the leaflet fixing structure including a supporting component and leaflet connecting components located on both sides of the supporting component; the leaflet connecting component includes a double-row hole structure, each row of holes in the double-row hole structure includes at least one non-closed hole.

[0007] Optionally, the leaflet fixing structure may be disposed at the outflow end of the stent body, or on the outer surface along the circumference of the stent body.

[0008] Optionally, a plurality of the leaflet connecting components may be uniformly arranged along the circumference of the cross section of the stent body.

[0009] Optionally, when each row of holes in the double-row hole structure includes a plurality of non-closed holes, the two rows of holes in the double-row hole structure may be symmetrically arranged along the central axis of the supporting component.

[0010] Optionally, the diameter of each hole in the double-row hole structure in the axial direction is adapted to the required contact height of two adjacent leaflets in the axial direction, and / or the number of holes in each row of the double-row hole structure is adapted to the required contact height of two adjacent leaflets in the axial direction.

[0011] Optionally, the diameter of each hole in the double-row hole structure in the axial direction may range from 0.6 mm to 2 mm.

[0012] Optionally, the number of holes in each row of the double-row hole structure may be 1-4.

[0013] Optionally, the number of the leaflet fixing structures is the same as the number of the leaflets.

[0014] Optionally, when the leaflet fixing structure is disposed at the outflow end of the stent body, the leaflet fixing structure is inclined toward the axial direction of the stent body so that the leaflet fixing structure forms a preset angle with the central axis of the stent body.

[0015] Optionally, a preset angle formed by the leaflet fixing structure and the central axis of the stent body has a value ranging from 0° to 15°.

[0016] Optionally, the joining area of ​​two adjacent leaflets can be sutured to the leaflet connecting component to connect the leaflet to the stent body.

[0017] Optionally, when each hole of the leaflet connecting component is a non-closed hole that passes through the leaflet connecting component and has a notch on one side, a suture thread used to sew the joining area of ​​two adjacent leaflets to the leaflet connecting component is embedded in the notch of the leaflet connecting component.

[0018] Compared with the prior art, the technical solution of the present invention has at least one of the following beneficial effects:

[0019] In the heart valve prosthesis provided by the present invention, under the condition that the leaflet connecting components have the same size, compared with the prior art in which closed holes are set on the leaflet fixing structure, the embodiment of the present invention sets a plurality of leaflet connecting components with a double-row hole structure in which each row of holes includes at least one non-closed hole in the stent body in the heart valve prosthesis, thereby achieving a larger number of suture holes with a more compact distribution on the leaflet fixing structure, increasing the connection points between the leaflet and the stent, and achieving the situation in which the outer diameter of the stent does not increase after compression, thereby enhancing the connection strength between the leaflet and the stent, thereby improving the stability of the heart valve prosthesis in the working state. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 It is a structural schematic diagram of a heart valve prosthesis in one embodiment of the present invention;

[0021] Figure 2 for Figure 1 a front view of the corresponding heart valve prosthesis;

[0022] Figure 3 It is a schematic structural diagram of a valve leaflet in a heart valve stent according to an embodiment of the present invention;

[0023] Figure 4 Schematic diagram of the structure of a heart valve stent in one embodiment of the present invention;

[0024] Figure 5 It is an enlarged structural schematic diagram of a leaflet fixing structure in a heart valve stent in one embodiment of the present invention.

[0025] The reference numerals are as follows:

[0026] 1-heart valve stent; 2-skirt;

[0027] 3- leaflets; 4- junction area;

[0028] 5- upper edge of the leaflet; 6- lower edge of the leaflet;

[0029] 7- suture; 11- inflow end;

[0030] 12-outflow end; 13-leaflet fixing structure;

[0031] 131 - leaflet connecting component; 132 - supporting component. DETAILED DESCRIPTION

[0032] A heart valve prosthesis of the present invention will be described in further detail below. The present invention will be described in more detail below with reference to the accompanying drawings, in which preferred embodiments of the present invention are shown, and it should be understood that those skilled in the art can modify the present invention described herein and still achieve the beneficial effects of the present invention. Therefore, the following description should be understood as being widely known to those skilled in the art and not as a limitation of the present invention.

[0033] For the sake of clarity, not all features of the actual embodiments are described. In the following description, well-known functions are not described in detail because they would clutter the invention with unnecessary detail. It should be recognized that in the development of any actual embodiment, a large number of implementation details must be made to achieve the developer's specific goals, such as changing from one embodiment to another according to the limitations of the relevant system or the relevant business. In addition, it should be recognized that such development work may be complex and time-consuming, but it is just a routine task for those skilled in the art.

[0034] As described in the background technology, in the prior art, the mechanical properties of the artificial heart valve stent for interventional surgery are relatively poor, which will affect the connection between the leaflets and the stent, resulting in the defect of poor connection stability between the leaflets and the stent, and thus making it easy for the stent to deform under the impact of blood during the normal operation of the artificial heart valve at the lesion position in the human body, especially when the leaflets and the stent joint are deformed, the contact area of ​​the leaflets is insufficient when the heart valve is in a closed state, and in severe cases, the artificial heart valve prosthesis fails. Furthermore, for the transcatheter heart valve system, the valve stent is compressed into the sheath of the delivery system, and the delivery of the valve stent is achieved by the axial movement of the sheath, so the outer diameter (profile) of the valve stent after compression needs to be slightly smaller than the inner diameter of the sheath. If only the number of connection holes between the leaflets and the stent in the prior art is increased, the outer diameter (profile) of the valve stent after compression will increase.

[0035] To this end, the present invention provides a heart valve prosthesis to enhance the connection strength between the valve leaflets and the stent in the heart valve prosthesis without increasing the outer diameter of the stent in the heart valve prosthesis after compression.

[0036] It should be noted that, in practical applications, the side where blood flows into the artificial heart valve prosthesis is usually called the inflow end of the heart valve stent, and the side where blood flows out of the artificial heart valve prosthesis is called the outflow end of the heart valve stent, according to the flow direction of blood in the artificial heart valve prosthesis. It is understandable that the inflow end and the outflow end are only used to identify the flow direction of blood, and do not specifically limit the specific position of each part in the artificial heart valve prosthesis.

[0037] Axial refers to the direction of the rotation center of a cylindrical object, that is, the same direction as the central axis. In an embodiment of the present invention, the axial direction of the stent body refers to the direction extending along the inflow end and the outflow end of the stent body.

[0038] A heart valve prosthesis provided by the present invention will be further described below in conjunction with the accompanying drawings and embodiments.

[0039] Please refer to Figure 1 and Figure 2 , Figure 1 is a schematic structural diagram of a heart valve prosthesis provided in one embodiment of the present invention, Figure 2 for Figure 1 A front view of the heart valve prosthesis described in.

[0040] like Figure 1 and Figure 2 As shown, the heart valve prosthesis includes a heart valve stent 1 , a skirt 2 and a heart valve, and the heart valve includes at least two leaflets 3 .

[0041] In this embodiment, the heart valve stent 1 is used to carry an artificial heart valve. In order to match the actual situation of a human heart valve, the artificial heart valve may generally include a plurality of leaflets 3. Figure 3 As shown, each leaflet 3 may specifically include a leaflet lower edge 6 (for connecting the leaflet 3 to the skirt 2), a leaflet upper edge 5 and a commissure 4 (for fixing two adjacent leaflets 3). The joining area of ​​adjacent leaflets 3 in the artificial heart valve may be referred to as a commissure 4 of two adjacent leaflets 3; and the leaflet 3 may be connected to the stent 1 through the commissure 4, for example, by folding or wrapping the stent and then suturing the stent.

[0042] See also Figure 4 , Figure 4 for Figure 1 and Figure 2 The structural schematic diagram of the heart valve stent 1 shown in FIG. Figure 4As shown, the heart valve stent includes a stent body, and the stent body includes interconnected grid-like structural units from the inflow end 11 to the outflow end 12. In addition, the stent body also includes a plurality of leaflet fixing structures 13 for connecting the stent body and the leaflets 3.

[0043] The material of the stent body may be a shape memory alloy, and preferably, the stent body is a nickel-titanium metal material.

[0044] In this embodiment, the attached Figure 4 The inlet of the large-mouth end surface of the upper half of the grid-like structure is called the inflow end 11 of the stent body, and the outlet of the small-mouth end surface of the lower half of the grid-like structure is called the outflow end 12 of the stent body. Exemplarily, each of the leaflet fixing structures 13 can be arranged at the outflow end 12 of the stent body, so that the multiple leaflet fixing structures 13 are connected to the grid-like structure, such as Figure 4 As shown. Preferably, the leaflet fixing structure 13 is inclined toward the axial direction of the stent body so that the leaflet fixing structure 13 forms a preset angle with the central axis of the stent body. Wherein, the preset angle formed by the leaflet fixing structure 13 and the central axis of the stent body preferably ranges from 0° to 15°. This arrangement can make the leaflet fixing structure 13 better match the shape of the corresponding native heart tissue after implantation, thereby reducing the impact on the native heart tissue.

[0045] In an embodiment of the present invention, the leaflet fixing structure 13 is inclined toward the axial direction of the stent body, which can avoid damage to part of the native tissue of the human heart on the one hand, and on the other hand, can better adapt to the shape of the valve leaflets when closed, thereby extending the service life of the heart valve prosthesis.

[0046] In an optional solution, each of the leaflet fixing structures 13 can also be arranged on the outer surface along the circumference of the stent body, that is, on the outer surface of the circumference of a stent body between the inflow end and the outflow end of the stent body, so that the leaflet fixing structure 13 matches the shape of the valve leaflets, thereby reducing stress concentration, extending the service life of the suture, and ultimately extending the service life of the valve prosthesis. The leaflet fixing structure 13 is preferably formed integrally with the stent body by laser cutting.

[0047] For a clearer description, the structure of the leaflet fixing structure 13 is specifically described below through the following embodiments.

[0048] Please refer to Figure 5 , Figure 5 FIG. 1 is an enlarged structural diagram of the leaflet fixing structure 13 in one embodiment of the present invention. Figure 5As shown, the leaflet fixing structure 13 includes a support component 132 and a leaflet connecting component 131 located on both sides of the support component 132. The leaflet connecting component 131 includes a double-row hole structure, and each row of holes in the double-row hole structure may include at least one non-closed hole. Each row of holes of the leaflet connecting component 131 is arranged along the axial direction of the support component 132. The axial direction is the direction extending along the two ends of the support component 132 of the leaflet fixing structure 13.

[0049] It can be understood that the non-closed hole in the embodiment of the present invention refers to a through hole with a notch on one side of the side wall, and the opening of the notch faces the side of the leaflet connecting component away from the supporting component.

[0050] In this embodiment, each hole of the leaflet connecting component 131 is a non-closed hole that passes through the leaflet connecting component 131, and the notches of the two rows of holes are arranged opposite to each other, and the edge of the leaflet connecting component 131 is opened. Under the condition that the leaflet connecting components have the same size, compared with the prior art of setting closed holes on the leaflet fixing structure, the embodiment of the present invention sets non-closed holes on the leaflet fixing structure 13, which can achieve the setting of more and more compact suture holes, thereby increasing the connection points between the leaflet and the stent, and achieving the enhancement of the connection strength between the leaflet and the stent without increasing the stent profile. Limited by the existing process level, the minimum size of the closed hole can only be D1, and if a non-closed hole is set, the minimum size of the non-closed hole can be much smaller than D1, so on the leaflet fixing structure of the same size, a larger number of non-closed holes with a more compact distribution can be set.

[0051] Optionally, multiple leaflet connecting parts 131 are arranged uniformly or non-uniformly along the cross-sectional circumference of the stent body. For example, when there are three leaflet connecting parts 131, the angle between the line connecting each two adjacent leaflet connecting parts 131 to the central axis of the stent body is 120°, which can be understood as the three leaflet connecting parts 131 are uniformly arranged along the cross-sectional circumference of the stent body; in order to match the special cross-sectional shape of certain stents, such as the D-shaped cross-sectional shape of the mitral stent, the angle between the line connecting two adjacent leaflet connecting parts 131 to the central axis of the stent body can also be set to 160°, 100°, and 100°, which can be understood as the three leaflet connecting parts 131 are non-uniformly arranged along the cross-sectional circumference of the stent body.

[0052] In addition, when each row of holes in the double-row hole structure of the leaflet connecting component 131 includes a plurality of non-closed holes, the two rows of holes in the double-row hole structure can be symmetrically arranged along the central axis of the supporting component 132 .

[0053] Furthermore, the diameter of each hole in the double-row hole structure in the axial direction is adapted to the required contact height of two adjacent leaflets in the axial direction, and / or the number of holes in each row in the double-row hole structure is adapted to the required contact height of two adjacent leaflets in the axial direction. Specifically, the diameter of each hole in the axial direction, the number of holes in each row, and the axial distance between adjacent holes jointly determine the required contact height of two adjacent leaflets in the axial direction.

[0054] Preferably, the diameter of each hole in the double-row hole structure in the axial direction may range from 0.6 mm to 5 mm, and the number of holes in each row of the double-row hole structure may range from 1 to 4. Furthermore, the overall height of the double-row hole structure in the axial direction may range from 2.5 mm to 5 mm.

[0055] In this embodiment, since the number of holes in each row of the double-row hole structure and the aperture size of each hole in the axial direction can be designed in different numbers and sizes according to different actual needs, it is possible to appropriately adjust the contact height of two adjacent leaflets in the heart valve prosthesis in the axial direction according to actual needs (usually by extending the contact height), thereby solving the problem of high difficulty in closing the valve leaflets. In addition, the non-closed double-row hole structure of the leaflet connecting component 141 can further reduce the volume of each leaflet connecting component, thereby facilitating the reduction of the radial diameter of the heart valve prosthesis after crimping, and thus being more suitable for the engineering design of the stent.

[0056] Optional, continue to see Figure 4 , and combined with Figure 3 and Figure 1 It can be seen that the joining areas 4 of two adjacent leaflets 3 are sutured to the leaflet connecting structure 131 so that the heart valve is fixedly arranged on the inner surface of the stent body.

[0057] In this embodiment, the joint area 4 of the adjacent leaflets 3 is sutured and connected to the leaflet connection part 131 of the stent body, thereby achieving stable fixation of two adjacent valve leaflets. Therefore, preferably, the number of the leaflet fixing structures 13 is the same as the number of leaflets included in the heart valve disposed on the stent body. In addition, the central axis of each leaflet fixing structure 13 coincides with or is parallel to the axis of the joint area 4 between the adjacent leaflets.

[0058] Optionally, when each hole of the leaflet connecting component 131 is a non-closed hole that passes through the leaflet connecting component 131 and has a notch on one side, the suture thread used to sew the joining area of ​​two adjacent leaflets 3 to the leaflet connecting component 131 is embedded in the notch of the leaflet connecting structure 131.

[0059] To sum up, in the heart valve prosthesis provided by the present invention, under the condition that the leaflet connecting components have the same size, compared with the prior art in which closed holes are set on the leaflet fixing structure, the embodiment of the present invention sets a plurality of leaflet connecting components with a double-row hole structure in which each row of holes includes at least one non-closed hole in the stent body in the heart valve prosthesis, thereby achieving a larger number of suture holes with a more compact distribution on the leaflet fixing structure, increasing the connection points between the leaflet and the stent, and achieving the situation that the outer diameter of the stent does not increase after compression, thereby enhancing the connection strength between the leaflet and the stent, thereby improving the stability of the heart valve prosthesis in the working state.

[0060] It should be noted that, although the present invention has been disclosed as a preferred embodiment, the above embodiment is not intended to limit the present invention. For any technician familiar with the art, without departing from the scope of the technical solution of the present invention, the technical content disclosed above can be used to make many possible changes and modifications to the technical solution of the present invention, or modified into equivalent embodiments of equivalent changes. Therefore, any simple modification, equivalent change and modification made to the above embodiment according to the technical essence of the present invention without departing from the content of the technical solution of the present invention still belongs to the scope of protection of the technical solution of the present invention.

[0061] It should also be understood that, unless otherwise specified or indicated, the terms "first", "second", "third", etc. in the specification are merely used to distinguish between the various components, elements, steps, etc. in the specification, and are not used to indicate the logical relationship or sequential relationship between the various components, elements, steps, etc.

[0062] It should also be recognized that the terms described herein are only used to describe specific embodiments and are not intended to limit the scope of the invention. It should be noted that the singular forms "a" and "an" used herein and in the appended claims include plural references unless the context clearly indicates otherwise. For example, a reference to "a step" or "a device" means a reference to one or more steps or devices, and may include secondary steps and secondary devices. All conjunctions used should be understood in the broadest sense. And, the word "or" should be understood to have the definition of a logical "or", rather than a logical "exclusive or", unless the context clearly indicates otherwise. In addition, the implementation of the method and / or device in the embodiments of the present invention may include performing the selected task manually, automatically, or in combination.

Claims

1. A heart valve prosthesis, comprising a stent body and at least two leaflets connected to the stent body, wherein the stent body comprises interconnected grid-like structural units from an inflow end to an outflow end, characterized in that: The stent body also includes a plurality of leaflet fixing structures for connecting the stent body and the leaflets, the leaflet fixing structures include a supporting component and leaflet connecting components located on both sides of the supporting component, the leaflet connecting components include a double-row hole structure, and each row of holes in the double-row hole structure includes at least one non-closed hole; wherein the leaflet fixing structure is arranged at the outflow end of the stent body, and the leaflet fixing structure is inclined toward the axial direction of the stent body so that the leaflet fixing structure forms a preset angle with the central axis of the stent body.

2. The heart valve prosthesis according to claim 1, characterized in that: The leaflet connecting components are evenly arranged along the circumference of the cross section of the stent body.

3. The heart valve prosthesis according to claim 1, characterized in that: When each row of holes in the double-row hole structure includes a plurality of non-closed holes, the two rows of holes in the double-row hole structure are symmetrically arranged along the central axis of the supporting component.

4. The heart valve prosthesis according to claim 1, characterized in that: The diameter of each hole in the double-row hole structure along the axial direction of the support component is adapted to the required contact height of two adjacent leaflets in the axial direction of the support component, and / or the number of holes in each row of the double-row hole structure is adapted to the required contact height of two adjacent leaflets in the axial direction of the support component.

5. The heart valve prosthesis according to claim 4, characterized in that: The diameter of each hole in the double-row hole structure along the axial direction of the support component ranges from 0.6 mm to 2 mm.

6. The heart valve prosthesis according to claim 4, characterized in that: The number of holes in each row of the double-row hole structure is 1-4.

7. The heart valve prosthesis according to claim 1, characterized in that: The number of the leaflet fixing structures is the same as the number of the leaflets.

8. The heart valve prosthesis according to claim 1, characterized in that: The preset angle has a value range of 0° to 15°.

9. The heart valve prosthesis according to any one of claims 1 to 8, characterized in that: The joining areas of two adjacent leaflets are sutured to the leaflet connecting component so that the leaflets are connected to the stent body.

10. The heart valve prosthesis according to claim 9, characterized in that: When each hole of the leaflet connecting component is a non-closed hole that passes through the leaflet connecting component and has a notch on one side, the suture thread used to sew the joining area of ​​two adjacent leaflets to the leaflet connecting component is embedded in the notch of the leaflet connecting component.

11. A heart valve prosthesis, comprising a stent body and at least two leaflets connected to the stent body, wherein the stent body comprises interconnected grid-like structural units from an inflow end to an outflow end, characterized in that: The stent body also includes a plurality of leaflet fixing structures for connecting the stent body and the leaflets, the leaflet fixing structures include a supporting component and leaflet connecting components located on both sides of the supporting component, the leaflet connecting components include a double-row hole structure, and each row of holes in the double-row hole structure includes at least one non-closed hole; wherein the leaflet fixing structures are arranged on the outer surface along the circumference of the stent body.

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