CN114681135B - A heart valve prosthesis - Google Patents
A heart valve prosthesis Download PDFInfo
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- CN114681135B CN114681135B CN202011611922.8A CN202011611922A CN114681135B CN 114681135 B CN114681135 B CN 114681135B CN 202011611922 A CN202011611922 A CN 202011611922A CN 114681135 B CN114681135 B CN 114681135B
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- valve prosthesis
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- 210000003709 heart valve Anatomy 0.000 title claims abstract description 74
- 230000009977 dual effect Effects 0.000 claims 2
- 230000006835 compression Effects 0.000 abstract description 9
- 238000007906 compression Methods 0.000 abstract description 9
- 239000011148 porous material Substances 0.000 description 10
- 210000002216 heart Anatomy 0.000 description 5
- 239000008280 blood Substances 0.000 description 4
- 210000004369 blood Anatomy 0.000 description 4
- 230000017531 blood circulation Effects 0.000 description 4
- 230000006870 function Effects 0.000 description 4
- 238000000034 method Methods 0.000 description 3
- 230000004048 modification Effects 0.000 description 3
- 238000012986 modification Methods 0.000 description 3
- 230000000149 penetrating effect Effects 0.000 description 3
- 230000002861 ventricular Effects 0.000 description 3
- 230000009286 beneficial effect Effects 0.000 description 2
- 210000005242 cardiac chamber Anatomy 0.000 description 2
- 230000000747 cardiac effect Effects 0.000 description 2
- 230000007547 defect Effects 0.000 description 2
- 230000018109 developmental process Effects 0.000 description 2
- 210000005003 heart tissue Anatomy 0.000 description 2
- 208000018578 heart valve disease Diseases 0.000 description 2
- 210000005240 left ventricle Anatomy 0.000 description 2
- 210000004115 mitral valve Anatomy 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 210000005241 right ventricle Anatomy 0.000 description 2
- HZEWFHLRYVTOIW-UHFFFAOYSA-N [Ti].[Ni] Chemical group [Ti].[Ni] HZEWFHLRYVTOIW-UHFFFAOYSA-N 0.000 description 1
- 230000032683 aging Effects 0.000 description 1
- 210000000709 aorta Anatomy 0.000 description 1
- 210000001765 aortic valve Anatomy 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 230000004064 dysfunction Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 210000002837 heart atrium Anatomy 0.000 description 1
- 230000000004 hemodynamic effect Effects 0.000 description 1
- 238000002513 implantation Methods 0.000 description 1
- 238000003698 laser cutting Methods 0.000 description 1
- 210000005246 left atrium Anatomy 0.000 description 1
- 230000003902 lesion Effects 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 239000007769 metal material Substances 0.000 description 1
- 229910001000 nickel titanium Inorganic materials 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 230000036285 pathological change Effects 0.000 description 1
- 231100000915 pathological change Toxicity 0.000 description 1
- 230000007170 pathology Effects 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 210000001147 pulmonary artery Anatomy 0.000 description 1
- 230000002685 pulmonary effect Effects 0.000 description 1
- 210000003102 pulmonary valve Anatomy 0.000 description 1
- 230000008439 repair process Effects 0.000 description 1
- 210000005245 right atrium Anatomy 0.000 description 1
- 229910001285 shape-memory alloy Inorganic materials 0.000 description 1
- 230000035882 stress Effects 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 210000000591 tricuspid valve Anatomy 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2418—Scaffolds therefor, e.g. support stents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2463—Implants forming part of the valve leaflets
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
Landscapes
- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
The invention provides a heart valve prosthesis, which is applied to the technical field of interventional medical prostheses. Compared with the prior art that the closed holes are formed in the valve leaflet fixing structure under the condition that the sizes of the valve leaflet connecting parts are the same, the valve leaflet fixing structure is provided with the valve leaflet connecting parts which are in a double-row hole structure and at least comprise one non-closed hole in each row of holes, so that more suture holes which are distributed compactly can be formed in the valve leaflet fixing structure, the connecting points of the valve leaflet and the support are increased, the connecting strength of the valve leaflet and the support is enhanced under the condition that the outer diameter of the support is not increased after compression, and the stability of the valve leaflet fixing structure in a working state is further improved.
Description
Technical Field
The invention relates to the technical field of interventional medical prostheses, in particular to a heart valve prosthesis.
Background
The heart contains four heart chambers, the left atrium and left ventricle being located on the left side of the heart and the right atrium and right ventricle being located on the right side of the heart. The atrium and ventricle form a ventricular inflow channel structure, the left ventricle and the aorta form a left ventricular outflow channel structure, and the right ventricle and the pulmonary artery form a right ventricular outflow channel structure. Valves with a one-way valve function are arranged at the positions of the chamber inflow channel structure and the chamber outflow channel structure, so that the normal flow of blood in the heart chamber is ensured. When this valve becomes problematic, cardiac hemodynamics changes and cardiac dysfunction, known as valvular heart disease.
With the prolongation of human life and aging of the population, the incidence of heart valve disease is increasing. According to literature statistics, valve diseases exist in 2% -7% of the elderly aged over 65 years. Prosthetic heart valves (HEART VALVE Prothesis) are prosthetic organs implantable in the heart to replace heart valves (including aortic, pulmonary, tricuspid and mitral valves) and to permit unidirectional blood flow, with the function of a natural heart valve. When heart valve pathology is severe and valve function cannot be restored or improved by valve detachment or repair, then prosthetic heart valve replacement is necessary. The design of interventional heart valves is difficult due to the complexity of the replacement of the interventional heart valves. For example, in practical applications, prosthetic heart valves have certain requirements for the contact area of the valve leaflets after closure and the stability of the leaflet attachment to the stent.
However, in the prior art, the mechanical property of the bracket of the artificial heart valve for interventional operation is relatively poor, which affects the connection between the valve leaflet and the bracket, so that the defect of poor connection stability between the valve leaflet and the bracket is caused, and then the valve shift easily occurs under the impact of blood in the normal operation process of the artificial heart valve at the pathological change position in the human body, so that the contact area of the valve leaflet is insufficient when the heart valve is in a closed state, and the problem of failure of the artificial heart valve prosthesis is caused under severe conditions. Further, for transcatheter heart valve systems, the valve stent is compressed into the sheath of the delivery system, and delivery of the valve stent is achieved by axial movement of the sheath, so the valve stent's outer diameter (profile) after compression needs to be slightly smaller than the inner diameter of the sheath. And if the number of connecting holes between the valve leaflet and the stent is only increased in the prior art, the external diameter (profile) of the valve stent after compression is increased. Therefore, how to enhance the strength of the connection between the leaflets and the stent without increasing the outer diameter (profile) of the valve stent after compression is a challenge.
Disclosure of Invention
The present invention aims to provide a heart valve prosthesis to enhance the strength of the connection between the leaflets and the stent in the heart valve prosthesis without increasing the outer diameter of the stent in the heart valve prosthesis after compression.
In order to solve the technical problems, the invention provides a heart valve prosthesis, which comprises a bracket main body and at least two valve leaflets connected to the bracket main body, wherein the bracket main body comprises a grid-shaped structural unit which is connected with each other from an inflow end to an outflow end, the bracket main body further comprises a plurality of valve leaflet fixing structures, each valve leaflet fixing structure comprises a supporting part and valve leaflet connecting parts positioned at two sides of the supporting part, each valve leaflet connecting part comprises a double-row hole structure, and each row hole in the double-row hole structure at least comprises one non-closed hole.
Alternatively, the leaflet fastening structure may be provided at the outflow end of the stent body or on an outer surface in the circumferential direction of the stent body.
Alternatively, a plurality of the leaflet attachment members may be uniformly disposed along the cross-sectional circumferential direction of the stent body.
Alternatively, when each row of holes in the double row hole structure includes a plurality of non-closed holes, two rows of holes in the double row hole structure may be symmetrically disposed along a central axis of the support member.
Optionally, the pore size of each pore in the double-row pore structure in the axial direction is adapted to the required contact height of two adjacent petals in the axial direction, and/or the number of pores in each row in the double-row pore structure is adapted to the required contact height of two adjacent petals in the axial direction.
Optionally, the range of the aperture of each hole in the double-row hole structure in the axial direction may be 0.6 mm-2 mm.
Alternatively, the number of holes in each row of the double row hole structure may be 1-4.
Optionally, the number of leaflet fastening structures is the same as the number of leaflets.
Optionally, when the leaflet fastening structure is disposed at the outflow end of the stent body, the leaflet fastening structure is inclined toward the axial direction of the stent body so that the leaflet fastening structure forms a preset angle with the central axis of the stent body.
Optionally, the preset angle formed by the leaflet fixing structure and the central axis of the bracket main body ranges from 0 degrees to 15 degrees.
Alternatively, the bonded areas of two adjacent leaflets may be sewn to the leaflet attachment members so that the leaflets are attached to the stent body.
Alternatively, when each hole of the leaflet attachment member is a non-closed hole penetrating the leaflet attachment member and having a notch on one side, a suture thread for suturing a bonding region of two adjacent leaflets to the leaflet attachment member is inlaid in the notch of the leaflet attachment member.
Compared with the prior art, the technical scheme of the invention has at least one of the following beneficial effects:
Compared with the prior art that the closed holes are formed in the valve leaflet fixing structure under the condition that the sizes of the valve leaflet connecting parts are the same, the valve leaflet fixing structure is provided with the valve leaflet connecting parts which are in a double-row hole structure and at least comprise one non-closed hole in each row of holes, so that more suture holes which are distributed compactly can be formed in the valve leaflet fixing structure, the connecting points of the valve leaflet and the support are increased, the connecting strength of the valve leaflet and the support is enhanced under the condition that the outer diameter of the support is not increased after compression, and the stability of the valve leaflet fixing structure in a working state is further improved.
Drawings
FIG. 1 is a schematic illustration of the structure of a heart valve prosthesis in accordance with one embodiment of the present invention;
FIG. 2 is a front view of the heart valve prosthesis of FIG. 1;
FIG. 3 is a schematic view of the structure of valve leaflets in a heart valve stent in accordance with an embodiment of the present invention;
FIG. 4 is a schematic view of a heart valve stent according to an embodiment of the present invention;
fig. 5 is an enlarged schematic view of a leaflet retainer structure in a heart valve stent in accordance with an embodiment of the present invention.
Wherein, the reference numerals are as follows:
1-heart valve stent, 2-skirt;
3-leaflet, 4-binding region;
5-leaflet upper edge, 6-leaflet lower edge;
7-suture thread, 11-inflow end;
A 12-outflow end, a 13-leaflet fixation structure;
131-leaflet attachment components, 132-support components.
Detailed Description
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 attached drawings, in which preferred embodiments of the present invention are shown, it being understood that one skilled in the art can modify the present invention described herein while still achieving the advantageous effects of the present invention. Accordingly, the following description is to be construed as broadly known to those skilled in the art and not as limiting the invention.
In the interest of clarity, not all features of an actual implementation are described. In the following description, well-known functions have not been described in detail because they would obscure the present invention in unnecessary detail. It should be appreciated that in the development of any such actual embodiment, numerous implementation details must be made to achieve the developer's specific goals, such as compliance with system-related or business-related constraints, which will vary from one implementation to another. In addition, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art.
As described in the background art, because in the prior art, the mechanical properties of the artificial heart valve stent for interventional operation are relatively poor, which affects the connection between the valve leaflet and the stent, and causes the defect of poor connection stability between the valve leaflet and the stent, so that the artificial heart valve is easy to deform under the impact of blood in the normal operation process of the lesion position in the human body, especially, when the joint of the valve leaflet and the stent deforms, the contact area of the valve leaflet is insufficient and the artificial heart valve prosthesis fails in serious cases. Further, for transcatheter heart valve systems, the valve stent is compressed into the sheath of the delivery system, and delivery of the valve stent is achieved by axial movement of the sheath, so the valve stent's outer diameter (profile) after compression needs to be slightly smaller than the inner diameter of the sheath. And if the number of connecting holes between the valve leaflet and the stent is only increased in the prior art, the external diameter (profile) of the valve stent after compression is increased.
To this end, the present invention provides a heart valve prosthesis to enhance the strength of the connection between the leaflets and the stent in the heart valve prosthesis without an increase in the outer diameter of the stent after compression in the heart valve prosthesis.
In practical applications, generally, depending on the direction of blood flowing into the prosthetic heart valve prosthesis, the side of the prosthetic heart valve prosthesis into which blood flows is referred to as the inflow end of the heart valve stent, and the side of the prosthetic heart valve prosthesis from which blood flows is referred to as the outflow end of the heart valve stent. It will be appreciated that the inflow and outflow ends are merely used to identify the direction of blood flow and do not specifically define the specific location of each portion within the prosthetic heart valve prosthesis.
The axial direction refers to the direction of the rotation center of the cylindrical-like body, that is, the direction common to the central axis, and in the embodiment of the present invention, the axial direction of the stent body refers to the direction extending along both ends of the inflow end and the outflow end of the stent body.
A heart valve prosthesis according to the present invention will be further described with reference to the drawings and examples.
Referring to fig. 1 and 2, fig. 1 is a schematic structural view of a heart valve prosthesis according to an embodiment of the present invention, and fig. 2 is a front view of the heart valve prosthesis shown in fig. 1.
As shown in fig. 1 and 2, the heart valve prosthesis comprises a heart valve stent 1, a skirt 2 and a heart valve comprising at least two leaflets 3.
In this embodiment, the heart valve support 1 is used to carry a prosthetic heart valve, and in order to match the actual situation of the heart valve, the prosthetic heart valve may generally include a plurality of valve leaflets 3. In an embodiment of the invention, as shown in fig. 3, each leaflet 3 may specifically include a leaflet lower edge 6 (for connecting the leaflet 3 with the skirt 2), a leaflet upper edge 5, and a bonding region 4 (for securing two adjacent leaflets 3). Wherein the coaptation region of adjacent leaflets 3 in the prosthetic heart valve can be referred to as the coaptation region 4 of adjacent two leaflets 3 (commissure), and the leaflets 3 can be attached to the stent 1 by the coaptation region 4, e.g., folded over or wrapped around the stent and then sutured to the stent.
Referring to fig. 4, fig. 4 is a schematic structural view of the heart valve stent 1 shown in fig. 1 and 2. As shown in fig. 4, the heart valve stent comprises a stent body comprising interconnected lattice-like structural elements from an inflow end 11 to an outflow end 12. And, the stent body further includes a plurality of leaflet fastening structures 13 for connecting the stent body and the leaflets 3.
The material of the bracket main body can be shape memory alloy, and preferably, the bracket main body is nickel titanium metal material.
In this embodiment, the inlet of the large-mouth end face of the upper half of the mesh-like structure in fig. 4 is referred to as the inflow end 11 of the stent body, and the outlet of the small-mouth end face of the lower half of the mesh-like structure is referred to as the outflow end 12 of the stent body. Illustratively, each of the leaflet retainer structures 13 may be disposed at the outflow end 12 of the stent body such that the plurality of leaflet retainer structures 13 are connected to the lattice structure, as shown in fig. 4. Preferably, the leaflet fixing structure 13 is inclined toward the axial direction of the stent body such that the leaflet fixing structure 13 forms a preset angle with the central axis of the stent body. The preset angle formed by the leaflet fixing structure 13 and the central axis of the stent main body is preferably in a range of 0-15 degrees. This arrangement allows the leaflet retainer structure 13 to better match the shape of the corresponding native heart tissue after implantation, reducing the impact on the native heart tissue.
In the embodiment of the present invention, the leaflet fixing structure 13 is inclined toward the axial direction of the stent body, so that on one hand, damage to the native tissue of the heart portion of the human body can be avoided, and on the other hand, the form of the valve leaflet when closed can be more adapted, thereby prolonging the service life of the heart valve prosthesis.
In an alternative solution, each leaflet fastening structure 13 may also be disposed on an outer surface along the circumferential direction of the stent body, that is, on an outer surface of a certain stent body disposed between the inflow end and the outflow end of the stent body, so that the leaflet fastening structure 13 matches the valve leaflet in shape, thereby reducing stress concentration, prolonging the service life of the suture thread, and finally prolonging the service life of the valve prosthesis. The leaflet retainer structure 13 is preferably integrally formed with the stent body by laser cutting.
For clarity of description, the structure of the leaflet fixing structure 13 is specifically described below by the following embodiment.
Referring to fig. 5, fig. 5 is an enlarged schematic view of the leaflet fastening structure 13 according to an embodiment of the present invention. As shown in fig. 5, the leaflet fastening structure 13 includes a support member 132 and leaflet attachment members 131 positioned at both sides of the support member 132. Wherein the leaflet attachment member 131 comprises a double row hole structure, and each row of holes in the double row hole structure may comprise at least one non-closed hole. Each row of holes of the leaflet attachment member 131 is aligned in the axial direction of the support member 132. Wherein the axial direction is a direction extending along both ends of the support member 132 of the leaflet fixing structure 13.
It is understood that the non-closed hole in the embodiment of the present invention refers to a through hole having a notch on one side of the sidewall, and the opening of the notch faces to the side of the leaflet attachment component away from the support component.
In this embodiment, each hole of the leaflet connecting member 131 is a non-closed hole penetrating the leaflet connecting member 131, and the notches of the two rows of holes are disposed opposite to each other, and the edge of the leaflet connecting member 131 is opened. Under the condition that the sizes of the leaflet connecting components are the same, compared with the condition that the leaflet fixing structure is provided with the closed holes in the prior art, the embodiment of the invention has the advantages that the non-closed holes are arranged on the leaflet fixing structure 13, so that more suture holes with more numbers and more compact distribution can be arranged, the connecting points of the leaflet and the stent are increased, and the connection strength of the leaflet and the stent is enhanced under the condition that the profile of the stent is not increased. Limited to the state of the art, the minimum size of the closed holes can only be D1, whereas if non-closed holes are provided, the minimum size of the non-closed holes can be much smaller than D1, so that on a leaflet fastening structure of the same size, a greater number of more compactly distributed non-closed holes can be provided.
Optionally, a plurality of the leaflet attachment members 131 are uniformly or non-uniformly disposed circumferentially along the cross-section of the stent body. For example, when the number of the leaflet attachment members 131 is 3, the included angle between the lines of each adjacent two of the leaflet attachment members 131 to the central axis of the stent body is 120 °, which can be understood that 3 of the leaflet attachment members 131 are uniformly disposed along the circumferential direction of the cross section of the stent body, and the included angle between the lines of each adjacent two of the leaflet attachment members 131 to the central axis of the stent body is 160 °, 100 °, which can be understood that 3 of the leaflet attachment members 131 are non-uniformly disposed along the circumferential direction of the cross section of the stent body, for matching the specific cross-sectional shape of some stents, such as the D-shaped cross section of a mitral valve stent.
Further, when each row of holes in the double row hole structure of the leaflet attachment member 131 includes a plurality of non-closed holes, two rows of holes in the double row hole structure may be symmetrically disposed along the central axis of the support member 132.
Further, the pore size of each pore in the double-row pore structure in the axial direction is adapted to the contact height required by two adjacent valve leaflets in the axial direction, and/or the number of pores in each row in the double-row pore structure is adapted to the contact height required by two adjacent valve leaflets in the axial direction. In particular, the size of the aperture of each hole in the axial direction, the number of holes in each row, the axial distance between adjacent holes, together determine the required contact height of two adjacent leaflets in the axial direction.
Preferably, the range of the aperture of each hole in the double-row hole structure in the axial direction may be 0.6mm to 5mm, and the number of each row of holes in the double-row hole structure may be 1 to 4. Further, the overall height of the double-row hole structure along the axial direction can be within a range of 2.5 mm-5 mm.
In this embodiment, because the number of each row of holes in the double row hole structure and the size of the aperture of each hole in the axial direction can be designed according to different actual requirements, the contact height (usually, the contact height is prolonged) of two adjacent valve leaflets in the heart valve prosthesis in the axial direction can be properly adjusted according to the actual requirements, and the problem of high closing difficulty of the valve leaflets is further solved. In addition, the non-closed double-row hole structure of the leaflet connecting members 141 can further reduce the volume of each leaflet connecting member, thereby being beneficial to reducing the radial diameter of the heart valve prosthesis after being held, and being more suitable for engineering design of the stent.
Optionally, with continued reference to fig. 4, and as can be seen in conjunction with fig. 3 and 1, the bonding areas 4 of two adjacent leaflets 3 are sewn to the leaflet attachment structure 131 so that the heart valve is fixedly disposed on the inner surface of the stent body.
In this embodiment, the bonding area 4 of the adjacent valve leaflets 3 is stitched to the leaflet connecting portion 131 of the stent body, so that stable fixation of the adjacent two valve leaflets is achieved. Therefore, it is preferable that the number of the leaflet fixing structures 13 is the same as the number of the leaflets contained in the heart valve provided on the stent body. The central axis of each leaflet fastening structure 13 coincides with or is parallel to the axis of the bonding region 4 between adjacent leaflets.
Alternatively, when each hole of the leaflet attachment member 131 is a non-closed hole penetrating the leaflet attachment member 131 and having a notch on one side, a suture thread for suturing the bonding region of two adjacent sheets of the leaflet 3 to the leaflet attachment member 131 is inlaid in the notch of the leaflet attachment structure 131.
In summary, in the heart valve prosthesis provided by the invention, under the condition that the sizes of the leaflet connecting parts are the same, compared with the condition that the leaflet fixing structure is provided with the closed holes in the prior art, the embodiment of the invention is provided with the leaflet connecting parts with the double-row hole structure, wherein each row of holes at least comprise one non-closed hole, in the stent main body of the heart valve prosthesis, so that the plurality of suture holes which are more and more compactly distributed can be arranged on the leaflet fixing structure, the connecting points of the leaflet and the stent are increased, the connecting strength of the leaflet and the stent is enhanced under the condition that the outer diameter of the stent is not increased after the stent is compressed, and the stability of the heart valve prosthesis in a working state is further improved.
It should be noted that although the present invention has been disclosed in the preferred embodiments, the above embodiments are not intended to limit the present invention. Many possible variations and modifications of the disclosed technology can be made by anyone skilled in the art without departing from the scope of the technology, or the technology can be modified to be equivalent. Therefore, any simple modification, equivalent variation and modification of the above embodiments according to the technical substance of the present invention still fall within the scope of the technical solution of the present invention.
It should be further understood that the terms "first," "second," "third," and the like in this specification are used merely for distinguishing between various components, elements, steps, etc. in the specification and not for indicating a logical or sequential relationship between the various components, elements, steps, etc., unless otherwise indicated.
It should also be understood that the terminology described herein is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present invention. It must be noted that, as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. For example, reference to "a step" or "an apparatus" means a reference to one or more steps or apparatuses, and may include sub-steps as well as sub-apparatuses. All conjunctions used should be understood in the broadest sense. And, the word "or" should be understood as having the definition of a logical "or" rather than a logical "exclusive or" unless the context clearly indicates the contrary. Furthermore, implementation of the methods and/or apparatus in embodiments of the invention may include performing selected tasks manually, automatically, or in combination.
Claims (11)
1. The heart valve prosthesis comprises a support body and at least two valve leaflets connected to the support body, wherein the support body comprises a grid-shaped structural unit which is connected with each other from an inflow end to an outflow end, and the heart valve prosthesis is characterized in that the support body further comprises a plurality of valve leaflet fixing structures used for connecting the support body and the valve leaflets, each valve leaflet fixing structure comprises a support part and valve leaflet connecting parts positioned on two sides of the support part, each valve leaflet connecting part comprises a double-row hole structure, each row of holes in the double-row hole structure at least comprises one non-closed hole, the valve leaflet fixing structures are arranged at the outflow end of the support body, and the valve leaflet fixing structures incline towards the axial direction of the support body, so that the valve leaflet fixing structures form a preset angle with the central axis of the support body.
2. The heart valve prosthesis of claim 1, wherein the leaflet attachment members are disposed uniformly along a cross-sectional circumference of the stent body.
3. The heart valve prosthesis of claim 1, wherein when each row of apertures in the dual row aperture structure comprises a plurality of non-closed apertures, two rows of apertures in the dual row aperture structure are symmetrically disposed along a central axis of the support member.
4. The heart valve prosthesis of claim 1, wherein the aperture size of each hole in the double row hole structure in the axial direction of the support member is adapted to the required contact height of two adjacent leaflets in the axial direction of the support member 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 member.
5. The heart valve prosthesis of claim 4, wherein each aperture of the double row of apertures is in the range of 0.6mm to 2mm in diameter along the axial direction of the support member.
6. The heart valve prosthesis of claim 4, wherein the number of holes per row in the double row hole structure is 1-4.
7. The heart valve prosthesis of claim 1, wherein the number of leaflet fixation structures is the same as the number of leaflets.
8. The heart valve prosthesis of claim 1, wherein the predetermined angle is in the range of 0 ° to 15 °.
9. The heart valve prosthesis of any one of claims 1-8, wherein the bonded areas of two adjacent leaflets are sewn to the leaflet attachment component to attach the leaflets to the stent body.
10. The heart valve prosthesis of claim 9, wherein when each aperture of the leaflet attachment component is a non-closed aperture extending through the leaflet attachment component and having a notch on one side, a suture for suturing a bonding region of two adjacent leaflets to the leaflet attachment component is inlaid in the notch of the leaflet attachment component.
11. A heart valve prosthesis comprising a stent body and at least two leaflets connected to the stent body, the stent body comprising interconnected lattice-like structural units from an inflow end to an outflow end, characterized in that the stent body further comprises a plurality of leaflet fastening structures for connecting the stent body with the leaflets, the leaflet fastening structures comprising a support member and leaflet attachment members on both sides of the support member, the leaflet attachment members comprising a double row hole structure, each row of holes in the double row hole structure comprising at least one non-closed hole, wherein the leaflet fastening structures are provided on an outer surface in a circumferential direction of the stent body.
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| CN202011611922.8A CN114681135B (en) | 2020-12-30 | 2020-12-30 | A heart valve prosthesis |
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| CN202011611922.8A CN114681135B (en) | 2020-12-30 | 2020-12-30 | A heart valve prosthesis |
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| CN114681135B true CN114681135B (en) | 2025-04-25 |
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| CN110123490A (en) * | 2019-04-08 | 2019-08-16 | 北京佰仁医疗科技股份有限公司 | The intervention pulmonary valve and intervention aorta petal of a kind of bracket and the connection structure and application of the leaflet connection structure |
| CN111035473A (en) * | 2018-10-15 | 2020-04-21 | 上海微创心通医疗科技有限公司 | Artificial heart valve prosthesis and stent thereof |
| CN215937813U (en) * | 2020-12-30 | 2022-03-04 | 上海微创心通医疗科技有限公司 | Heart valve prosthesis |
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|---|---|---|---|---|
| ES2792354T3 (en) * | 2008-07-15 | 2020-11-11 | St Jude Medical Llc | Foldable and re-expandable prosthetic heart valves, with axial anchoring, for various disease states |
| US10543085B2 (en) * | 2012-12-31 | 2020-01-28 | Edwards Lifesciences Corporation | One-piece heart valve stents adapted for post-implant expansion |
| CN109394393A (en) * | 2017-08-18 | 2019-03-01 | 上海微创心通医疗科技有限公司 | Heart valve prosthesis |
| US20200188097A1 (en) * | 2018-12-12 | 2020-06-18 | Vdyne, Llc | Compressible Bileaflet Frame for Side Delivered Transcatheter Heart Valve |
| CN210301307U (en) * | 2019-03-22 | 2020-04-14 | 上海微创心通医疗科技有限公司 | Heart valve support and prosthesis thereof |
| CN211485096U (en) * | 2019-11-22 | 2020-09-15 | 上海微创心通医疗科技有限公司 | Heart valve prosthesis |
| CN111329623B (en) * | 2020-03-05 | 2021-09-03 | 杭州金杭齐医疗科技有限公司 | Intervention type artificial heart valve |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN111035473A (en) * | 2018-10-15 | 2020-04-21 | 上海微创心通医疗科技有限公司 | Artificial heart valve prosthesis and stent thereof |
| CN110123490A (en) * | 2019-04-08 | 2019-08-16 | 北京佰仁医疗科技股份有限公司 | The intervention pulmonary valve and intervention aorta petal of a kind of bracket and the connection structure and application of the leaflet connection structure |
| CN215937813U (en) * | 2020-12-30 | 2022-03-04 | 上海微创心通医疗科技有限公司 | Heart valve prosthesis |
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