WO2023206709A1 - Valve stent, valve prosthesis, and valve prosthesis system - Google Patents
Valve stent, valve prosthesis, and valve prosthesis system Download PDFInfo
- Publication number
- WO2023206709A1 WO2023206709A1 PCT/CN2022/096675 CN2022096675W WO2023206709A1 WO 2023206709 A1 WO2023206709 A1 WO 2023206709A1 CN 2022096675 W CN2022096675 W CN 2022096675W WO 2023206709 A1 WO2023206709 A1 WO 2023206709A1
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- WIPO (PCT)
- Prior art keywords
- valve
- hanging
- stent
- section
- valve stent
- Prior art date
Links
- 210000005069 ears Anatomy 0.000 claims description 52
- 230000000712 assembly Effects 0.000 claims description 4
- 238000000429 assembly Methods 0.000 claims description 4
- 210000004115 mitral valve Anatomy 0.000 description 11
- 210000003709 heart valve Anatomy 0.000 description 6
- 210000001519 tissue Anatomy 0.000 description 4
- 230000002861 ventricular Effects 0.000 description 4
- 230000006378 damage Effects 0.000 description 3
- 238000010586 diagram Methods 0.000 description 3
- 201000010099 disease Diseases 0.000 description 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 3
- 210000005240 left ventricle Anatomy 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 230000004048 modification Effects 0.000 description 3
- 238000012986 modification Methods 0.000 description 3
- 238000000926 separation method Methods 0.000 description 3
- 230000009286 beneficial effect Effects 0.000 description 2
- 230000005540 biological transmission Effects 0.000 description 2
- 210000003698 chordae tendineae Anatomy 0.000 description 2
- 230000008878 coupling Effects 0.000 description 2
- 238000010168 coupling process Methods 0.000 description 2
- 238000005859 coupling reaction Methods 0.000 description 2
- 238000002788 crimping Methods 0.000 description 2
- 208000018578 heart valve disease Diseases 0.000 description 2
- 210000003540 papillary muscle Anatomy 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- 230000007704 transition Effects 0.000 description 2
- 210000000591 tricuspid valve Anatomy 0.000 description 2
- 206010020772 Hypertension Diseases 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 210000003484 anatomy Anatomy 0.000 description 1
- 210000001765 aortic valve Anatomy 0.000 description 1
- 230000000903 blocking effect Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 208000029078 coronary artery disease Diseases 0.000 description 1
- 238000006073 displacement reaction Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 210000005246 left atrium Anatomy 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000002324 minimally invasive surgery Methods 0.000 description 1
- 230000008722 morphological abnormality Effects 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 210000003102 pulmonary valve Anatomy 0.000 description 1
- 230000008439 repair process Effects 0.000 description 1
Images
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
-
- 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
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2436—Deployment by retracting a sheath
-
- 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
Definitions
- the present invention relates to the technical field of medical devices, and in particular to a valve stent, a valve prosthesis and a valve prosthesis system.
- Heart Valve Prothesis is an artificial organ that can be implanted into the heart to replace heart valves (including aortic valve, pulmonary valve, tricuspid valve and mitral valve), allows blood to flow in one direction, and has the function of natural heart valves. .
- heart valve disease is severe and valve separation surgery or repair surgery cannot be used to restore or improve valve function, artificial heart valve replacement must be used.
- Interventional heart valve replacement is a minimally invasive procedure that is controlled by a delivery system to place a valve prosthesis at the location of the disease.
- the design of artificial valve stent is very difficult.
- the pressing and holding shape of the valve stent is uneven; when the valve stent is released, the valve stent The release accuracy is not high.
- the diseased mitral valve annulus is generally relatively large in size and requires a valve stent with a larger structure. This will cause the valve used for mitral valve replacement to be pressed and held. There will be greater challenges upon release.
- crimping the stent into the sheath it is more difficult to obtain a more uniform crimping shape for the mitral valve stent.
- the structure around the mitral valve is complex. There are many sub-mitral valve tissue structures in the left ventricle, such as papillary muscles, chordae tendineae, left ventricular outflow tract, etc. If the stent used in the mitral valve extends too far into the left ventricle, it may cause damage to these tissue structures or cause obstruction of the left ventricular outflow tract.
- the purpose of the present invention is to provide a valve stent, a valve prosthesis and a valve prosthesis system to solve the current problems in the valve stent that the shape of the valve stent is uneven when it is pressed and held, and the accuracy of the release of the valve stent is not high.
- the present invention provides a valve stent, which includes an inflow channel section, an outflow channel section and a hanging ear section arranged in sequence along the axial direction of the valve stent; the outflow channel section has a leaflet connection part, so The leaflet connecting part is used to connect the leaflets; the hanging ear section at least includes a pair of hanging ears provided on both sides along the axial direction of the leaflet connecting part, or the hanging ear section at least includes a pair of hanging ears provided on A hanging ear is located along the axial extension position of the leaflet connection portion.
- the number of hanging ears included in the hanging ear section is an even multiple of the number of leaflet connecting parts, and a pair of hanging ears are symmetrically arranged along both sides of the axial direction of each leaflet connecting part.
- the hanging ears are symmetrically arranged along both sides of the axial direction of each leaflet connecting part.
- the number of hanging ears included in the hanging ear section is an odd multiple of the number of leaflet connecting parts, and one is provided along the axially extending position of each leaflet connecting part.
- the hanging ears are an odd multiple of the number of leaflet connecting parts, and one is provided along the axially extending position of each leaflet connecting part.
- the number of hanging ears included in the hanging ear section is non-odd multiples and non-even multiples of the number of leaflet connecting parts, and part of the hanging ears are arranged along the leaflet.
- the remaining hanging lugs are arranged on both sides that are symmetrical along the axial direction of the leaflet connecting portion.
- the outflow channel section has a plurality of leaflet connecting portions, and a pair of hanging lugs are symmetrically arranged along both sides of the axial direction of each leaflet connecting portion, and each pair of hanging lugs forms a pair of hanging lugs.
- Hanging ear assemblies a plurality of the hanging ear assemblies are evenly distributed along the circumferential direction of the valve stent; or, the outflow passage section has a plurality of leaflet connecting portions, along the location of each leaflet connecting portion.
- One hanging ear is provided at an axially extending position, and a plurality of hanging ears are evenly distributed along the circumferential direction of the valve stent.
- the outflow end of the outflow channel section has a row of grid frames distributed along the circumference of the valve stent, each of the grid frames is arranged in a concave hexagonal shape, and the concave hexagonal The concave angle is concave along the axial direction of the valve stent toward the inflow end.
- the outflow channel section also has a stent rod, the stent rod extends along the axial direction of the valve stent, and the hanging ear is connected to the stent rod.
- the hanging ear includes a straight section rod and a head end.
- the straight section rod extends along the axial direction of the valve stent.
- the head end is provided at the outflow end of the straight section rod.
- the size of the head end is larger than the width of the straight section rod; the head end is an arc-shaped structure or a polygonal structure.
- the present invention also provides a valve prosthesis, which includes: valve leaflets and the valve stent as described above.
- the valve leaflets are connected to the valve stent.
- the present invention also provides a valve prosthesis system, which includes: a delivery system and the valve prosthesis as described above; the ear-hanging section of the valve prosthesis is embedded in the delivery groove of the delivery system, When the valve prosthesis is released, the ear-hanging segments protrude from the delivery grooves.
- the valve stent includes an inflow channel section, an outflow channel section and a hanging ear section arranged in sequence along the axial direction of the valve stent;
- the outflow channel section has a leaflet connecting portion, and the leaflet connecting portion is used to connect the leaflets;
- the hanging ear section at least includes a pair of hanging ears provided on both sides along the axial direction of the leaflet connecting portion, or , the hanging ear section at least includes a hanging ear arranged at a position extending along the axial direction of the leaflet connecting portion.
- the ear-hanging section can ensure uniform stress on the valve leaflet connection portion, thereby improving uniform force on the valve stent as a whole, thereby improving the uniformity of the valve stent being pressed into the delivery system and the accuracy during release.
- Figure 1 is a schematic diagram of a valve stent provided by an embodiment of the present invention.
- Figure 2 is a schematic view of the valve stent provided by an embodiment of the present invention from another angle.
- Figure 3 is a schematic diagram of a hanging ear of a valve stent provided by an embodiment of the present invention.
- Figure 4 is a schematic diagram of a valve prosthesis provided by an embodiment of the present invention.
- 20-outflow tract section 21-valve leaflet connection part, 22-grid frame, 221-concave angle, 23-stent rod;
- first”, “second” and “third” may explicitly or implicitly include one or at least two of these features, and the terms “mounted”, “connected” and “connected” shall be Broadly understood, for example, it can be a fixed connection, a detachable connection, or an integral body; it can be a direct connection or an indirect connection through an intermediate medium; it can be an internal connection between two elements or an interaction between two elements. .
- one element is disposed on another element, which usually only means that there is a connection, coupling, matching or transmission relationship between the two elements, and the relationship between the two elements may be direct or indirect through an intermediate element.
- connection, coupling, cooperation or transmission and cannot be understood as indicating or implying the spatial positional relationship between two elements, that is, one element can be in any position inside, outside, above, below or to one side of another element, unless the content Also clearly stated.
- the specific meanings of the above terms in the present invention can be understood according to specific circumstances. Additionally, in the following description, numerous specific details are given in order to provide a more thorough understanding of the invention. However, it will be apparent to one skilled in the art that the present invention may be practiced without one or more of these details. In other instances, some technical features that are well known in the art are not described in order to avoid confusion with the present invention.
- the invention provides a valve stent, a valve prosthesis and a valve prosthesis system.
- the valve stent includes an inflow channel section, an outflow channel section and a hanging ear section arranged in sequence along the axial direction of the valve stent; the outflow channel
- the segment has a leaflet connecting portion, and the leaflet connecting portion is used to connect the leaflets;
- the hanging ear section at least includes a pair of hanging ears provided on both sides along the axial direction of the leaflet connecting portion, or the
- the hanging ear section at least includes a hanging ear arranged at a position extending along the axial direction of the leaflet connecting portion.
- the ear-hanging section can ensure uniform stress on the valve leaflet connection portion, thereby improving uniform force on the valve stent as a whole, thereby improving the uniformity of the valve stent being pressed into the delivery system and the accuracy during release.
- This embodiment provides a valve stent, a valve prosthesis, and a valve prosthesis system.
- the valve stent includes: an inflow channel section 10 , an outflow channel section 20 , and a hanging ear section 30 that are sequentially arranged along the axial direction of the valve stent.
- the axial direction of the valve stent represents the direction from the inflow channel to the outflow channel.
- the outflow tract section 20 has a leaflet connecting portion 21, and the leaflet connecting portion 21 is used to connect the valve leaflet 1 so that the valve leaflet 1 is connected to the valve stent.
- the leaflet connecting portion 21 preferably represents the connecting portion of two adjacent leaflets 1 , that is, the portion where the two adjacent leaflets 1 are connected to the same valve stent. This portion is the leaflet connecting portion 21 .
- the leaflet connecting part 21 can be any rod on a stent grid, or a straight stent rod on the stent grid, or it can also be an angle part in the stent grid, as long as it can Just connect one part of the valve leaflet.
- the valve stent further includes a transition section 40 disposed between the inflow channel section 10 and the outflow channel section 20 .
- a transition section 40 disposed between the inflow channel section 10 and the outflow channel section 20 .
- the structure of the valve stent is not limited by Figure 1.
- a double-layer stent structure is added to the inflow section 20, or the contour trend of the valve stent is adaptively adjusted. Both are available.
- the hanging ear section 30 includes a hanging ear 31 .
- the hanging ear 31 is used to be embedded in a delivery groove of a delivery system to dispose the valve stent on the delivery system.
- the hanging ear 31 carries the force of the connection between the valve stent and the delivery system. When the valve prosthesis is released, the hanging ear section 30 protrudes from the delivery groove to achieve automatic separation.
- the conveying system and its grooves can be referred to the existing technology, and will not be described in detail here.
- the hanging ears 31 are provided at least on both sides along the axial direction of the leaflet connecting part 21, so that the hanging ear sections 30 can ensure that the force of the leaflet connecting part 21 is uniform, and thus the valve stent can be pressed and released during the pressing process.
- the uniform force during the process can also improve the accuracy of valve stent release.
- the hanging ears 31 are provided at least on two sides that are symmetrical along the axial direction of the leaflet connecting portion 21 .
- the arrangement of the hanging ears 31 can also ensure uniform stress on the leaflets.
- the hanging ear 31 is at least provided at a position extending along the axial direction of the leaflet connecting portion 21.
- the leaflet connecting portion 21 is located at a certain position in the circumferential direction of the valve stent. At this position has a direction parallel to the axial direction of the valve stent. This direction is the axial direction where the leaflet connecting portion 21 is located.
- Hanging ears 31 are provided along the extension direction of this axial direction, so that the leaflets connected to the hanging ears 31
- the leaflet connection part 21 can indirectly bear force with the delivery system, thereby ensuring the force stability of the leaflet connection part 21, thereby improving the uniform force of the entire valve stent, thereby improving the uniformity of the valve stent being pressed into the delivery system. and precision upon release. At the same time, such an arrangement can also ensure uniform stress on the leaflets.
- the number of the hanging ears 31 is an even multiple of the number of the leaflet connecting parts 21 , and the hanging ears 31 are at least disposed along the leaflet connecting parts 21 axially symmetrical sides.
- the number of the hanging ears 31 is, for example, twice that of the leaflet connecting portion 21 , and the hanging ears 31 are provided on both sides along the axial direction of the leaflet connecting portion 21 .
- there are connecting struts on both sides of the leaflet connecting portion 21 and the hanging ears 31 are directly provided on the connecting struts on both sides of the leaflet connecting portion 21 .
- the number of the leaflets is preferably three
- the number of the leaflet connecting parts 21 is preferably three
- the number of the hanging ears 31 is six
- every two hanging ears 31 constitute a hanging ear.
- the hanging ear components are distributed on both sides of the leaflet connecting part 21 .
- three pairs of hanging ear assemblies composed of these six hanging ears 31 are evenly distributed on the valve stent.
- at least part of the hanging ears 31 is provided on both axially symmetrical sides of the leaflet connecting part 21 , and part of the hanging ears 31 may not be symmetrically distributed. This arrangement is because the valve leaflet connecting part 21 is used to connect the valve stent and the part where two adjacent valve leaflets join.
- the material of this part will cause the valve stent to be uneven in shape and hang the ears when the valve stent is pressed into the sheath.
- the setting of 31 can effectively control the uniformity of the valve stent shape, so that the valve stent will not have morphological abnormalities after entering the sheath, such as overlap between the stent rods and inward depression of some areas of the stent, etc., resulting in stent be damaged. Therefore, this solution can ensure that the valve leaflet connecting portion 21 is stressed uniformly, further ensures that the force-bearing accuracy of the valve stent is improved, and the force-bearing uniformity and release accuracy of the valve stent are ensured.
- the hanging ears 31 are provided on two sides that are symmetrical along the axial direction of the leaflet connection part 21, the hanging ears 31 on the two opposite sides form a hanging ear assembly, and the hanging ear assembly is Evenly distributed along the circumference of the valve stent, the evenly distributed hanging ear components are finally released from the delivery system.
- the hanging ear components can stabilize the valve stent and detach from the sheath without causing the valve stent to tilt, thereby allowing the valve stent to tilt.
- the valve stent evenly fits the valve annulus, such as the mitral valve, to further ensure the stability of the valve stent and the accuracy of release.
- the number of the hanging ears 31 is an odd multiple of the number of the leaflet connecting parts 21 , and the hanging ears 31 are at least disposed at a position extending along the axial direction of the leaflet connecting parts 21 , similarly. It can ensure that the valve stent is evenly stressed and released accurately.
- the leaflet connecting part 21 is a straight connecting rod extending in the axial direction, and the hanging ear 31 is directly connected to the connecting straight rod and connected with the leaflet connecting part 21 on the same axis.
- the number of the hanging ears 31 and the number of the leaflet connecting parts 21 is preferably the same.
- the number of the hanging ears 31 can also be greater than the number of the leaflet connecting portions 21, and the remaining hanging ears 31 can be positioned selectively, and can also be arranged symmetrically according to the symmetry point of the valve stent.
- the hanging ears 31 are evenly distributed along the circumferential direction of the valve stent. That is, the leaflet connecting portions 21 can preferably be arranged to be evenly distributed in the circumferential direction, and the hanging ears 31 are also evenly distributed in the circumferential direction. Based on the above description of the evenly distributed hanging ear components, a single number of the hanging ears 31 can also be further distributed. To ensure the uniformity of the valve stent's pressing and gripping into the sheath and the accuracy of its release, we will not go into details here.
- the number of the hanging ears 31 is not an odd multiple and a non-even multiple of the number of the leaflet connecting portions 21 , and some of the hanging ears 31 are disposed along the edges of the leaflet connecting portions 21 .
- the remaining hanging lugs 31 are arranged on both sides that are symmetrical along the axial direction of the leaflet connecting portion 21 .
- the force of the valve stent is ensured to be uniform and the release accuracy is ensured.
- the outflow end of the outflow channel section 20 has a row of grid frames 22 distributed along the circumference of the valve stent, and the grid frames 22 are arranged in a concave hexagonal shape, so The concave angle 221 of the concave hexagon is concave along the axial direction of the valve stent toward the inflow end.
- This arrangement not only ensures that the valve stent can be pressed and held into the sheath, but also allows a connection structure between the rods connected to the rods on both sides of the concave angle 221 to provide structural stability of the valve stent.
- the rods connected to the rods on both sides of the concave angle 221 are straight rods.
- the concave hexagonal structure maintains the function and performance of the valve stent without increasing the longitudinal height of the valve stent, thus reducing the overall height of the valve stent and thus reducing the extension length of the interventional valve prosthesis.
- the safety of the valve stent is improved and the valve stent is prevented from causing damage to the tissue structure or blocking the left ventricular outflow tract.
- the valve stent includes a transition section 40 that fits the mitral valve annulus, so that the overall subvalvular height of the valve stent is reduced.
- the overall subvalvular height of the valve stent When the overall subvalvular height of the valve stent is reduced, the potential for interference between the valve stent and surrounding tissue is also reduced, thereby reducing the risk of injury to the native chordae tendineae or papillary muscles. At the same time, the lower subvalvular height of the valve stent will also reduce the risk of left ventricular outflow tract obstruction.
- the outflow channel section 20 also has a stent rod 23 extending along the axial direction of the valve stent, and the hanging ear 31 is connected to the stent rod 23, thus ensuring that the hanging ear 31 is connected to the stent rod 23.
- the hanging ear 31 includes a straight section rod 311 and a head end 312.
- the straight section rod 311 extends along the axial direction of the valve stent.
- the head end 312 is arranged at the outflow of the straight section rod 311.
- the size of the head end 312 is larger than the width of the straight section rod 311.
- the straight section rod 311 and the head end 312 can be embedded in the groove of the corresponding shape of the conveying system.
- the head end 312 changes shape at the end of the straight section of the straight section rod 311 to ensure that when the hanging ear 31 is embedded in the conveying system,
- the valve stent can have no relative axial displacement with the hanging ear connection part of the delivery system, so the valve stent can be squeezed and retracted into the delivery system, or it can restore its original shape and shape through its own expansion when it is released from the delivery system.
- conveyor system for separation More preferably, the head end 312 has an arc-shaped structure or a polygonal structure.
- the shape of the head end 312 may be a circular, elliptical or other arc-shaped structure, or may be a square, rectangular, rhombus or other polygonal structure.
- valve prosthesis includes: valve leaflets 1 and the valve stent as described above; the valve leaflets are connected to the valve stent.
- the leaflets 1 can be directly connected to the valve stent, and the leaflets 1 can also be connected to the valve stent through a leaflet connector 2.
- the valve leaflet connector is connected to the valve stent, and the valve leaflets are connected to the valve leaflet connector.
- the valve prosthesis is, for example, an artificial heart valve prosthesis, which is used for mitral valves, tricuspid valves, etc.
- the valve prosthesis has the beneficial effects brought by the valve stent, which will not be described in detail here.
- This embodiment also provides a valve prosthesis system, including: a delivery system and the valve prosthesis as described above; the hanging ear section 30 of the valve prosthesis is embedded in the delivery groove of the delivery system.
- the hanging ear section 30 is protruded from the conveying groove.
- the ear-hanging section 30 is connected to the groove on the valve delivery system, so that the stent can be fixed on the delivery system, so that the stent can be retracted into the delivery system after being pressed, and released from the delivery system through its own expansion force. After coming out, it will be separated automatically.
- the valve prosthesis system has the beneficial effects brought by the valve prosthesis, which will not be described in detail here. For other structural components of the valve prosthesis system, reference can be made to the prior art and will not be described here.
- the valve stent includes an inflow channel section, an outflow channel section and a hanging section along the axial direction of the valve stent.
- the ear segment; the outflow tract segment has a leaflet connecting portion, and the leaflet connecting portion is used to connect the leaflets;
- the ear hanging segment at least includes one provided on both sides along the axial direction of the leaflet connecting portion.
- the hanging ear, or the hanging ear section at least includes one hanging ear arranged at a position extending along the axial direction where the leaflet connecting portion is located.
- the ear-hanging section can ensure uniform stress on the valve leaflet connection portion, thereby improving uniform force on the valve stent as a whole, thereby improving the uniformity of the valve stent being pressed into the delivery system and the accuracy during release.
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- 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
A valve stent, a valve prosthesis, and a valve prosthesis system. The valve stent comprises, along an axial direction of the valve stent, an inflow channel section (10), an outflow channel section (20), and a hanging lug section (30) sequentially arranged. The outflow channel section (20) is provided with valve leaflet connecting parts (21). The valve leaflet connecting parts (21) are used for connecting valve leaflets (1). The hanging lug section (30) at least comprises a pair of hanging lugs (31) arranged on two sides along an axial direction of the valve leaflet connecting parts (21), or the hanging lug section (30) at least comprises a hanging lug (31) arranged at a position extending along the axial direction where the valve leaflet connecting parts (21) are located. In this way, the hanging lug section (30) can ensure uniform stress of the valve leaflet connecting parts (21), so as to improve the uniform stress of the whole valve stent, thereby improving the uniformity of the valve stent for being pressed into a delivery system and the accuracy during release.
Description
本发明涉及医疗器械技术领域,特别涉及一种瓣膜支架、瓣膜假体以及瓣膜假体系统。The present invention relates to the technical field of medical devices, and in particular to a valve stent, a valve prosthesis and a valve prosthesis system.
随着人类寿命的延长和人口的老年化,心脏瓣膜疾病的发病率越来越高。根据文献资料统计,年龄大于65岁的老年人中,有2%~7%的人存在瓣膜疾病。而在欧美国家,瓣膜疾病位于冠心病和高血压病之后,居第三位。人工心脏瓣膜(Heart Valve Prothesis)是可植入心脏内代替心脏瓣膜(包括主动脉瓣,肺动脉瓣,三尖瓣和二尖瓣),能使血液单向流动,具有天然心脏瓣膜功能的人工器官。当心脏瓣膜病变严重而不能用瓣膜分离手术或修补手术恢复或改善瓣膜功能时,则须采用人工心脏瓣膜置换术。介入心脏瓣膜置换术是通过微创伤手术,由输送系统控制,将瓣膜假体放置在病变位置。As human lifespan increases and the population ages, the incidence of heart valve disease is increasing. According to literature statistics, 2% to 7% of elderly people over 65 years old have valvular disease. In European and American countries, valvular disease ranks third after coronary heart disease and hypertension. Heart Valve Prothesis is an artificial organ that can be implanted into the heart to replace heart valves (including aortic valve, pulmonary valve, tricuspid valve and mitral valve), allows blood to flow in one direction, and has the function of natural heart valves. . When heart valve disease is severe and valve separation surgery or repair surgery cannot be used to restore or improve valve function, artificial heart valve replacement must be used. Interventional heart valve replacement is a minimally invasive procedure that is controlled by a delivery system to place a valve prosthesis at the location of the disease.
目前,由于瓣膜原生结构的复杂性,人工的瓣膜支架的设计难度很大,在瓣膜支架被压握入输送系统时,存在瓣膜支架的压握形态不均匀;在瓣膜支架被释放时,瓣膜支架释放的精准性不高。以二尖瓣为例,这体现在:1.病变的二尖瓣瓣环一般来说尺寸比较大,需要较大尺寸结构的瓣膜支架,这会导致二尖瓣置换使用的瓣膜在压握和释放时会有更大的挑战。在压握进入鞘管时,二尖瓣支架更难获得较均匀的压握形态。在释放时,由于二尖瓣的瓣环处于左心房和左心室的腔室交接处,其整体高度较低,因此对于释放的精准性要求也更高。2.二尖瓣周围结构复杂,在左心室内有很多二尖瓣瓣下组织结构,比如乳头肌,腱索,左室流出道等。如果二尖瓣瓣膜所使用的支架在左室内伸出长度过多,有可能会对这些组织结构造成损伤或者造成左室流出道堵塞。At present, due to the complexity of the original structure of the valve, the design of artificial valve stent is very difficult. When the valve stent is pressed and held into the delivery system, the pressing and holding shape of the valve stent is uneven; when the valve stent is released, the valve stent The release accuracy is not high. Taking the mitral valve as an example, this is reflected in the following: 1. The diseased mitral valve annulus is generally relatively large in size and requires a valve stent with a larger structure. This will cause the valve used for mitral valve replacement to be pressed and held. There will be greater challenges upon release. When crimping the stent into the sheath, it is more difficult to obtain a more uniform crimping shape for the mitral valve stent. During release, since the annulus of the mitral valve is located at the junction of the left atrium and left ventricle, its overall height is low, so the accuracy of release is also required. 2. The structure around the mitral valve is complex. There are many sub-mitral valve tissue structures in the left ventricle, such as papillary muscles, chordae tendineae, left ventricular outflow tract, etc. If the stent used in the mitral valve extends too far into the left ventricle, it may cause damage to these tissue structures or cause obstruction of the left ventricular outflow tract.
因此,开发出一种能够至少解决如上一种问题的瓣膜支架、瓣膜假体以及瓣膜假体系统,是亟待解决的问题。Therefore, developing a valve stent, valve prosthesis and valve prosthesis system that can at least solve the above problems is an urgent problem to be solved.
发明内容Contents of the invention
本发明的目的在于提供一种瓣膜支架、瓣膜假体以及瓣膜假体系统,以解决目前在瓣膜支架中,瓣膜支架被压握时形态不均匀,以及瓣膜支架释放的精准性不高的问题。The purpose of the present invention is to provide a valve stent, a valve prosthesis and a valve prosthesis system to solve the current problems in the valve stent that the shape of the valve stent is uneven when it is pressed and held, and the accuracy of the release of the valve stent is not high.
为解决上述技术问题,本发明提供一种瓣膜支架,沿所述瓣膜支架的轴向包括依次设置的流入道段、流出道段以及挂耳段;所述流出道段具有瓣叶连接部,所述瓣叶连接部用于连接瓣叶;所述挂耳段至少包括设置于沿所述瓣叶连接部的轴向的两侧的一对挂耳,或者,所述挂耳段至少包括设置于沿所述瓣叶连接部所在的轴向延伸的位置的一挂耳。In order to solve the above technical problems, the present invention provides a valve stent, which includes an inflow channel section, an outflow channel section and a hanging ear section arranged in sequence along the axial direction of the valve stent; the outflow channel section has a leaflet connection part, so The leaflet connecting part is used to connect the leaflets; the hanging ear section at least includes a pair of hanging ears provided on both sides along the axial direction of the leaflet connecting part, or the hanging ear section at least includes a pair of hanging ears provided on A hanging ear is located along the axial extension position of the leaflet connection portion.
可选的,所述挂耳段包括的所述挂耳的数量为所述瓣叶连接部的数量的双数倍,沿每个所述瓣叶连接部的轴向的两侧对称设置有一对所述挂耳。Optionally, the number of hanging ears included in the hanging ear section is an even multiple of the number of leaflet connecting parts, and a pair of hanging ears are symmetrically arranged along both sides of the axial direction of each leaflet connecting part. The hanging ears.
可选的,所述挂耳段包括的所述挂耳的数量为所述瓣叶连接部的数量的单数倍,沿每个所述瓣叶连接部所在的轴向延伸的位置设置有一个所述挂耳。Optionally, the number of hanging ears included in the hanging ear section is an odd multiple of the number of leaflet connecting parts, and one is provided along the axially extending position of each leaflet connecting part. The hanging ears.
可选的,所述挂耳段包括的所述挂耳的数量为所述瓣叶连接部的数量的非单数倍以及非双数倍,部分的所述挂耳设置于沿所述瓣叶连接部所在的轴向延伸的位置,其余的所述挂耳设置于沿所述瓣叶连接部的轴向相对称的两侧。Optionally, the number of hanging ears included in the hanging ear section is non-odd multiples and non-even multiples of the number of leaflet connecting parts, and part of the hanging ears are arranged along the leaflet. At the axially extending position where the connecting portion is located, the remaining hanging lugs are arranged on both sides that are symmetrical along the axial direction of the leaflet connecting portion.
可选的,所述流出道段具有多个所述瓣叶连接部,沿每个所述瓣叶连接部的轴向的两侧对称设置一对挂耳,每一对所述挂耳形成一挂耳组件,多个所述挂耳组件沿所述瓣膜支架的周向均匀分布;或者,所述流出道段具有多个所述瓣叶连接部,沿每个所述瓣叶连接部所在的轴向延伸的位置设置一个所述挂耳,多个所述挂耳沿所述瓣膜支架的周向均匀分布。Optionally, the outflow channel section has a plurality of leaflet connecting portions, and a pair of hanging lugs are symmetrically arranged along both sides of the axial direction of each leaflet connecting portion, and each pair of hanging lugs forms a pair of hanging lugs. Hanging ear assemblies, a plurality of the hanging ear assemblies are evenly distributed along the circumferential direction of the valve stent; or, the outflow passage section has a plurality of leaflet connecting portions, along the location of each leaflet connecting portion. One hanging ear is provided at an axially extending position, and a plurality of hanging ears are evenly distributed along the circumferential direction of the valve stent.
可选的,所述流出道段的流出端具有一排沿所述瓣膜支架的周向分布的网格架,每个所述网格架呈凹六边形设置,所述凹六边形的凹角沿所述瓣膜支架的轴向朝向流入端的方向内凹。Optionally, the outflow end of the outflow channel section has a row of grid frames distributed along the circumference of the valve stent, each of the grid frames is arranged in a concave hexagonal shape, and the concave hexagonal The concave angle is concave along the axial direction of the valve stent toward the inflow end.
可选的,所述流出道段还具有支架杆,所述支架杆沿所述瓣膜支架的轴向延伸,所述挂耳与所述支架杆连接。Optionally, the outflow channel section also has a stent rod, the stent rod extends along the axial direction of the valve stent, and the hanging ear is connected to the stent rod.
可选的,所述挂耳包括直段杆以及头端,所述直段杆沿所述瓣膜支架的 轴向延伸设置,所述头端设置于所述直段杆的流出端,沿所述直段杆的宽度方向,所述头端的尺寸大于所述直段杆的宽度;所述头端为弧线形结构或者多边形结构。Optionally, the hanging ear includes a straight section rod and a head end. The straight section rod extends along the axial direction of the valve stent. The head end is provided at the outflow end of the straight section rod. Along the In the width direction of the straight section rod, the size of the head end is larger than the width of the straight section rod; the head end is an arc-shaped structure or a polygonal structure.
为解决上述技术问题,本发明还提供一种瓣膜假体,所述瓣膜假体包括:瓣叶以及如上所述的瓣膜支架所述瓣叶与所述瓣膜支架连接。In order to solve the above technical problems, the present invention also provides a valve prosthesis, which includes: valve leaflets and the valve stent as described above. The valve leaflets are connected to the valve stent.
为解决上述技术问题,本发明还提供一种瓣膜假体系统,包括:输送系统以及如上所述的瓣膜假体;所述瓣膜假体的挂耳段嵌入所述输送系统的输送凹槽中,当释放瓣膜假体时,所述挂耳段从所述输送凹槽中脱出。In order to solve the above technical problems, the present invention also provides a valve prosthesis system, which includes: a delivery system and the valve prosthesis as described above; the ear-hanging section of the valve prosthesis is embedded in the delivery groove of the delivery system, When the valve prosthesis is released, the ear-hanging segments protrude from the delivery grooves.
在本发明提供的一种瓣膜支架、瓣膜假体以及瓣膜假体系统中,所述瓣膜支架沿所述瓣膜支架的轴向包括依次设置的流入道段、流出道段以及挂耳段;所述流出道段具有瓣叶连接部,所述瓣叶连接部用于连接瓣叶;所述挂耳段至少包括设置于沿所述瓣叶连接部的轴向的两侧的一对挂耳,或者,所述挂耳段至少包括设置于沿所述瓣叶连接部所在的轴向延伸的位置的一挂耳。如此,使得挂耳段能够保证瓣叶连接部的受力均匀,进而提高瓣膜支架整体受力均匀,从而提高瓣膜支架压握进入输送系统的均匀性以及在释放时的精准性。In the valve stent, valve prosthesis and valve prosthesis system provided by the present invention, the valve stent includes an inflow channel section, an outflow channel section and a hanging ear section arranged in sequence along the axial direction of the valve stent; The outflow channel section has a leaflet connecting portion, and the leaflet connecting portion is used to connect the leaflets; the hanging ear section at least includes a pair of hanging ears provided on both sides along the axial direction of the leaflet connecting portion, or , the hanging ear section at least includes a hanging ear arranged at a position extending along the axial direction of the leaflet connecting portion. In this way, the ear-hanging section can ensure uniform stress on the valve leaflet connection portion, thereby improving uniform force on the valve stent as a whole, thereby improving the uniformity of the valve stent being pressed into the delivery system and the accuracy during release.
本领域的普通技术人员将会理解,提供的附图用于更好地理解本发明,而不对本发明的范围构成任何限定。其中:Those of ordinary skill in the art will understand that the drawings are provided for a better understanding of the invention and do not constitute any limitation on the scope of the invention. in:
图1为本发明一实施例提供的瓣膜支架的示意图。Figure 1 is a schematic diagram of a valve stent provided by an embodiment of the present invention.
图2为本发明一实施例提供的瓣膜支架的另一角度的示意图。Figure 2 is a schematic view of the valve stent provided by an embodiment of the present invention from another angle.
图3为本发明一实施例提供的瓣膜支架的挂耳的示意图。Figure 3 is a schematic diagram of a hanging ear of a valve stent provided by an embodiment of the present invention.
图4为本发明一实施例提供的瓣膜假体的示意图。Figure 4 is a schematic diagram of a valve prosthesis provided by an embodiment of the present invention.
附图中:In the attached picture:
1-瓣叶;2-瓣叶连接件;1-leaf; 2-leaf connector;
10-流入道段;10-inflow section;
20-流出道段,21-瓣叶连接部,22-网格架,221-凹角,23-支架杆;20-outflow tract section, 21-valve leaflet connection part, 22-grid frame, 221-concave angle, 23-stent rod;
30-挂耳段,31-挂耳,311-直段杆,312-头端;30-mounting ear section, 31-mounting ear, 311-straight section rod, 312-head end;
40-过渡段。40-Transition section.
为使本发明的目的、优点和特征更加清楚,以下结合附图和具体实施例对本发明作进一步详细说明。需说明的是,附图均采用非常简化的形式且未按比例绘制,仅用以方便、明晰地辅助说明本发明实施例的目的。此外,附图所展示的结构往往是实际结构的一部分。特别的,各附图需要展示的侧重点不同,有时会采用不同的比例。In order to make the purpose, advantages and features of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that the drawings are in a very simplified form and are not drawn to scale, and are only used to conveniently and clearly assist in explaining the embodiments of the present invention. In addition, the structures shown in the drawings are often part of the actual structure. In particular, each drawing needs to display different emphasis, and sometimes uses different proportions.
如在本说明书中所使用的,单数形式“一”、“一个”以及“该”包括复数对象,除非内容另外明确指出外。如在本说明书中所使用的,术语“或”通常是以包括“和/或”的含义而进行使用的,除非内容另外明确指出外。术语“若干”通常是以包括“至少一个”的含义而进行使用的,术语“至少两个”通常是以包括“两个或两个以上”的含义而进行使用的,此外,术语“第一”、“第二”、“第三”仅用于描述目的,而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此,限定有“第一”、“第二”、“第三”的特征可以明示或者隐含地包括一个或者至少两个该特征,术语“安装”、“相连”、“连接”应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或成一体;可以是直接相连,也可以通过中间媒介间接相连,可以是两个元件内部的连通或两个元件的相互作用关系。此外,如在本发明中所使用的,一元件设置于另一元件,通常仅表示两元件之间存在连接、耦合、配合或传动关系,且两元件之间可以是直接的或通过中间元件间接的连接、耦合、配合或传动,而不能理解为指示或暗示两元件之间的空间位置关系,即一元件可以在另一元件的内部、外部、上方、下方或一侧等任意方位,除非内容另外明确指出外。对于本领域的普通技术人员而言,可以根据具体情况理解上述术语在本发明中的具体含义。另外,在下文的描述中,给出了大量具体的细节以便提供对本发明更为彻底的理解。然而,对于本领域技术人员而言显而易见的是,本发明可以无需一个或多个这些细节而得以实施。在其他的例子中,为了避免与本发明 发生混淆,对于本领域公知的一些技术特征未进行描述。As used in this specification, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally used in its sense including "and/or" unless the content clearly dictates otherwise. The term "several" is generally used in the sense of including "at least one", and the term "at least two" is generally used in the sense of including "two or more". In addition, the term "first ”, “second” and “third” are used for descriptive purposes only and cannot be understood as indicating or implying relative importance or implicitly indicating the quantity of indicated technical features. Therefore, the features defined as "first", "second" and "third" may explicitly or implicitly include one or at least two of these features, and the terms "mounted", "connected" and "connected" shall be Broadly understood, for example, it can be a fixed connection, a detachable connection, or an integral body; it can be a direct connection or an indirect connection through an intermediate medium; it can be an internal connection between two elements or an interaction between two elements. . In addition, as used in the present invention, one element is disposed on another element, which usually only means that there is a connection, coupling, matching or transmission relationship between the two elements, and the relationship between the two elements may be direct or indirect through an intermediate element. connection, coupling, cooperation or transmission, and cannot be understood as indicating or implying the spatial positional relationship between two elements, that is, one element can be in any position inside, outside, above, below or to one side of another element, unless the content Also clearly stated. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances. Additionally, in the following description, numerous specific details are given in order to provide a more thorough understanding of the invention. However, it will be apparent to one skilled in the art that the present invention may be practiced without one or more of these details. In other instances, some technical features that are well known in the art are not described in order to avoid confusion with the present invention.
本发明提供的一种瓣膜支架、瓣膜假体以及瓣膜假体系统,所述瓣膜支架沿所述瓣膜支架的轴向包括依次设置的流入道段、流出道段以及挂耳段;所述流出道段具有瓣叶连接部,所述瓣叶连接部用于连接瓣叶;所述挂耳段至少包括设置于沿所述瓣叶连接部的轴向的两侧的一对挂耳,或者,所述挂耳段至少包括设置于沿所述瓣叶连接部所在的轴向延伸的位置的一挂耳。如此,使得挂耳段能够保证瓣叶连接部的受力均匀,进而提高瓣膜支架整体受力均匀,从而提高瓣膜支架压握进入输送系统的均匀性以及在释放时的精准性。The invention provides a valve stent, a valve prosthesis and a valve prosthesis system. The valve stent includes an inflow channel section, an outflow channel section and a hanging ear section arranged in sequence along the axial direction of the valve stent; the outflow channel The segment has a leaflet connecting portion, and the leaflet connecting portion is used to connect the leaflets; the hanging ear section at least includes a pair of hanging ears provided on both sides along the axial direction of the leaflet connecting portion, or the The hanging ear section at least includes a hanging ear arranged at a position extending along the axial direction of the leaflet connecting portion. In this way, the ear-hanging section can ensure uniform stress on the valve leaflet connection portion, thereby improving uniform force on the valve stent as a whole, thereby improving the uniformity of the valve stent being pressed into the delivery system and the accuracy during release.
以下参考附图进行描述。Description will be made below with reference to the drawings.
本实施例提供了一种瓣膜支架、瓣膜假体以及瓣膜假体系统。This embodiment provides a valve stent, a valve prosthesis, and a valve prosthesis system.
如图1以及图2所示,所述瓣膜支架包括:沿所述瓣膜支架的轴向依次设置的流入道段10、流出道段20以及挂耳段30。其中,所述瓣膜支架的轴向表示流入道至流出道的方向。As shown in FIGS. 1 and 2 , the valve stent includes: an inflow channel section 10 , an outflow channel section 20 , and a hanging ear section 30 that are sequentially arranged along the axial direction of the valve stent. Wherein, the axial direction of the valve stent represents the direction from the inflow channel to the outflow channel.
所述流出道段20具有瓣叶连接部21,所述瓣叶连接部21用于连接瓣叶1,使得所述瓣叶1连接于所述瓣膜支架上。所述瓣叶连接部21优选表示的是相邻的两片瓣叶1的连接部分,即相邻的两片瓣叶1连接于同一个瓣膜支架的部位,这个部位即瓣叶连接部21。所述瓣叶连接部21可以是一支架网格上的任意一个杆,也可以是支架网格上的一个支架直杆,或者,也可以是支架网格中的一个夹角部位,只要是能够连接瓣叶的一个部位即可。优选的,所述瓣膜支架还包括过渡段40,所述过渡段40设置于所述流入道段10以及流出道段20之间。需理解,所述瓣膜支架的结构不受图1限制,例如,为使瓣膜支架更适合解剖学结构,在流入道段20增加双层支架结构,或对瓣膜支架的轮廓趋势进行适应性的调整均可。The outflow tract section 20 has a leaflet connecting portion 21, and the leaflet connecting portion 21 is used to connect the valve leaflet 1 so that the valve leaflet 1 is connected to the valve stent. The leaflet connecting portion 21 preferably represents the connecting portion of two adjacent leaflets 1 , that is, the portion where the two adjacent leaflets 1 are connected to the same valve stent. This portion is the leaflet connecting portion 21 . The leaflet connecting part 21 can be any rod on a stent grid, or a straight stent rod on the stent grid, or it can also be an angle part in the stent grid, as long as it can Just connect one part of the valve leaflet. Preferably, the valve stent further includes a transition section 40 disposed between the inflow channel section 10 and the outflow channel section 20 . It should be understood that the structure of the valve stent is not limited by Figure 1. For example, in order to make the valve stent more suitable for the anatomical structure, a double-layer stent structure is added to the inflow section 20, or the contour trend of the valve stent is adaptively adjusted. Both are available.
如图2与图3所示,所述挂耳段30包括挂耳31。需理解,所述挂耳31用于嵌入一输送系统的输送凹槽中,用以将所述瓣膜支架设置于所述输送系统上。挂耳31承载了瓣膜支架与输送系统之间的连接受力的作用,当释放瓣 膜假体时,所述挂耳段30从所述输送凹槽中脱出,实现自动分离。所述输送系统以及其凹槽可参考现有技术,本文在此不再赘述。所述挂耳31至少设置于沿所述瓣叶连接部21的轴向的两侧,进而使得挂耳段30能够保证瓣叶连接部21的受力均匀,进而使得瓣膜支架在压握和释放过程中受力均匀,还能够提高瓣膜支架释放时的精准性。进一步的,所述挂耳31至少设置于沿所述瓣叶连接部21的轴向相对称的两侧。另外,所述挂耳31的设置还可以保证瓣叶的受力均匀。As shown in FIGS. 2 and 3 , the hanging ear section 30 includes a hanging ear 31 . It should be understood that the hanging ear 31 is used to be embedded in a delivery groove of a delivery system to dispose the valve stent on the delivery system. The hanging ear 31 carries the force of the connection between the valve stent and the delivery system. When the valve prosthesis is released, the hanging ear section 30 protrudes from the delivery groove to achieve automatic separation. The conveying system and its grooves can be referred to the existing technology, and will not be described in detail here. The hanging ears 31 are provided at least on both sides along the axial direction of the leaflet connecting part 21, so that the hanging ear sections 30 can ensure that the force of the leaflet connecting part 21 is uniform, and thus the valve stent can be pressed and released during the pressing process. The uniform force during the process can also improve the accuracy of valve stent release. Furthermore, the hanging ears 31 are provided at least on two sides that are symmetrical along the axial direction of the leaflet connecting portion 21 . In addition, the arrangement of the hanging ears 31 can also ensure uniform stress on the leaflets.
或者,所述挂耳31至少设置于沿所述瓣叶连接部21所在的轴向延伸的位置,例如,所述瓣叶连接部21位于瓣膜支架的周向上的某一位置,在这一位置上,具有一个与瓣膜支架的轴向平行的方向,这个方向为所述瓣叶连接部21所在的轴向,沿这个轴向的延伸方向设置挂耳31,进而使得与挂耳31连接的瓣叶连接部21能够与输送系统进行间接受力,进而保证瓣叶连接部21的受力稳定性,进而提高了瓣膜支架整体的均匀受力,从而提高了瓣膜支架压握进入输送系统的均匀性以及在释放时的精准性。同时,如此设置,也同样能够保证瓣叶的受力均匀。Alternatively, the hanging ear 31 is at least provided at a position extending along the axial direction of the leaflet connecting portion 21. For example, the leaflet connecting portion 21 is located at a certain position in the circumferential direction of the valve stent. At this position has a direction parallel to the axial direction of the valve stent. This direction is the axial direction where the leaflet connecting portion 21 is located. Hanging ears 31 are provided along the extension direction of this axial direction, so that the leaflets connected to the hanging ears 31 The leaflet connection part 21 can indirectly bear force with the delivery system, thereby ensuring the force stability of the leaflet connection part 21, thereby improving the uniform force of the entire valve stent, thereby improving the uniformity of the valve stent being pressed into the delivery system. and precision upon release. At the same time, such an arrangement can also ensure uniform stress on the leaflets.
优选的,如图2与图4所示,所述挂耳31的数量为所述瓣叶连接部21的数量的双数倍,所述挂耳31至少设置于沿所述瓣叶连接部21的轴向相对称的两侧。优选的,在本实施例中,所述挂耳31的数量例如优选是瓣叶连接部21的两倍,所述挂耳31设置于沿所述瓣叶连接部21的轴向的两侧的位置,例如,瓣叶连接部21的两侧具有连接支杆,所述挂耳31直接设置于瓣叶连接部21的两侧的连接支杆上。更具体的,所述瓣叶的数量例如优选为三个,所述瓣叶连接部21的数量优选为三个,所述挂耳31的数量为六个,每两个挂耳31组成挂耳组件,挂耳组件分布在瓣叶连接部21的两侧。更佳的,这六个挂耳31组成的三对挂耳组件在瓣膜支架上均匀分布。在其他实施例中,所述挂耳31至少一部分设置于瓣叶连接部21的轴向对称的两侧,还有一部分可以不必对称分布。如此设置,是因为瓣叶连接部21用于连接瓣膜支架和相邻两片瓣叶接合的部分,这部分的材料会造成瓣膜支架在压握进鞘时,瓣膜支架形态的不均匀,挂耳31的设置可以有效控制瓣膜支架形态的均匀性, 使瓣膜支架在进入鞘管后不会出现形态的异常,比如支架杆与杆之间的重叠、支架部分区域的向内凹陷等,从而导致支架受到损伤。因此,本方案可以保证瓣叶连接部21受力均匀,进一步保证瓣膜支架的受力精度提高,保证瓣膜支架的受力均匀性以及释放时精准性。优选的,当所述挂耳31设置于沿所述瓣叶连接部21的轴向相对称的两侧时,相对称的两侧的所述挂耳31形成挂耳组件,所述挂耳组件沿所述瓣膜支架的周向均匀分布,均匀分布的挂耳组件是最后从输送系统里释放出来,挂耳组件可以让瓣膜支架稳定的同时脱离鞘管,不会使瓣膜支架产生倾斜,从而让瓣膜支架均匀和瓣环贴合,例如与二尖瓣瓣膜保持贴合,进一步保证瓣膜支架的稳定性以及释放的精准性。Preferably, as shown in FIGS. 2 and 4 , the number of the hanging ears 31 is an even multiple of the number of the leaflet connecting parts 21 , and the hanging ears 31 are at least disposed along the leaflet connecting parts 21 axially symmetrical sides. Preferably, in this embodiment, the number of the hanging ears 31 is, for example, twice that of the leaflet connecting portion 21 , and the hanging ears 31 are provided on both sides along the axial direction of the leaflet connecting portion 21 . For example, there are connecting struts on both sides of the leaflet connecting portion 21 , and the hanging ears 31 are directly provided on the connecting struts on both sides of the leaflet connecting portion 21 . More specifically, the number of the leaflets is preferably three, the number of the leaflet connecting parts 21 is preferably three, the number of the hanging ears 31 is six, and every two hanging ears 31 constitute a hanging ear. The hanging ear components are distributed on both sides of the leaflet connecting part 21 . Even better, three pairs of hanging ear assemblies composed of these six hanging ears 31 are evenly distributed on the valve stent. In other embodiments, at least part of the hanging ears 31 is provided on both axially symmetrical sides of the leaflet connecting part 21 , and part of the hanging ears 31 may not be symmetrically distributed. This arrangement is because the valve leaflet connecting part 21 is used to connect the valve stent and the part where two adjacent valve leaflets join. The material of this part will cause the valve stent to be uneven in shape and hang the ears when the valve stent is pressed into the sheath. The setting of 31 can effectively control the uniformity of the valve stent shape, so that the valve stent will not have morphological abnormalities after entering the sheath, such as overlap between the stent rods and inward depression of some areas of the stent, etc., resulting in stent be damaged. Therefore, this solution can ensure that the valve leaflet connecting portion 21 is stressed uniformly, further ensures that the force-bearing accuracy of the valve stent is improved, and the force-bearing uniformity and release accuracy of the valve stent are ensured. Preferably, when the hanging ears 31 are provided on two sides that are symmetrical along the axial direction of the leaflet connection part 21, the hanging ears 31 on the two opposite sides form a hanging ear assembly, and the hanging ear assembly is Evenly distributed along the circumference of the valve stent, the evenly distributed hanging ear components are finally released from the delivery system. The hanging ear components can stabilize the valve stent and detach from the sheath without causing the valve stent to tilt, thereby allowing the valve stent to tilt. The valve stent evenly fits the valve annulus, such as the mitral valve, to further ensure the stability of the valve stent and the accuracy of release.
优选的,所述挂耳31的数量为所述瓣叶连接部21的数量的单数倍,所述挂耳31至少设置于沿所述瓣叶连接部21所在的轴向延伸的位置,同样可以保证瓣膜支架的受力均匀以及释放时的精准性。优选的,所述瓣叶连接部21为一连接直杆,所述连接直杆沿轴向延伸,所述挂耳31直接连接于所述连接直杆上,并与所述瓣叶连接部21在同一轴线上。所述挂耳31的数量以及瓣叶连接部21的数量优选为数量相同。所述挂耳31的数量还可以大于所述瓣叶连接部21的数量,其余的挂耳31可以择位设置,还可以根据瓣膜支架的对称点位进行对称性的设置。优选的,当所述挂耳31设置于沿所述瓣叶连接部21所在的轴向延伸的位置时,所述挂耳21沿所述瓣膜支架的周向均匀分布。即,所述瓣叶连接部21可以优选设置为周向均匀分布,所述挂耳31也周向均匀分布,基于上述均匀分布的挂耳组件描述,单倍数的所述挂耳31也能够进一步保证瓣膜支架压握进入鞘管的均匀性以及释放时的精准性,此处不再赘述。Preferably, the number of the hanging ears 31 is an odd multiple of the number of the leaflet connecting parts 21 , and the hanging ears 31 are at least disposed at a position extending along the axial direction of the leaflet connecting parts 21 , similarly. It can ensure that the valve stent is evenly stressed and released accurately. Preferably, the leaflet connecting part 21 is a straight connecting rod extending in the axial direction, and the hanging ear 31 is directly connected to the connecting straight rod and connected with the leaflet connecting part 21 on the same axis. The number of the hanging ears 31 and the number of the leaflet connecting parts 21 is preferably the same. The number of the hanging ears 31 can also be greater than the number of the leaflet connecting portions 21, and the remaining hanging ears 31 can be positioned selectively, and can also be arranged symmetrically according to the symmetry point of the valve stent. Preferably, when the hanging ears 31 are disposed at a position extending along the axial direction of the leaflet connecting portion 21 , the hanging ears 21 are evenly distributed along the circumferential direction of the valve stent. That is, the leaflet connecting portions 21 can preferably be arranged to be evenly distributed in the circumferential direction, and the hanging ears 31 are also evenly distributed in the circumferential direction. Based on the above description of the evenly distributed hanging ear components, a single number of the hanging ears 31 can also be further distributed. To ensure the uniformity of the valve stent's pressing and gripping into the sheath and the accuracy of its release, we will not go into details here.
优选的,所述挂耳31的数量为所述瓣叶连接部21的数量的非单数倍以及非双数倍,部分的所述挂耳31设置于沿所述瓣叶连接部21所在的轴向延伸的位置,其余的所述挂耳31设置于沿所述瓣叶连接部21的轴向相对称的两侧,同样的,保证瓣膜支架的受力均匀以及释放时的精准性。Preferably, the number of the hanging ears 31 is not an odd multiple and a non-even multiple of the number of the leaflet connecting portions 21 , and some of the hanging ears 31 are disposed along the edges of the leaflet connecting portions 21 . In the axially extending position, the remaining hanging lugs 31 are arranged on both sides that are symmetrical along the axial direction of the leaflet connecting portion 21 . Likewise, the force of the valve stent is ensured to be uniform and the release accuracy is ensured.
优选的,如图2所示,所述流出道段20的流出端具有一排沿所述瓣膜支架的周向分布的网格架22,所述网格架22呈凹六边形设置,所述凹六边形的 凹角221沿所述瓣膜支架的轴向朝向流入端的方向内凹。如此设置,不仅可以保证瓣膜支架能够被压握进鞘管,还可以使与凹角221两侧的杆连接的杆之间有连接结构,提供瓣膜支架的结构稳定性。例如,与凹角221两侧的杆连接的杆为直杆,两个直杆之间通过这样的连接方式,保证结构的稳定性。此外,凹六边形的结构由于凹角内凹,在维持瓣膜支架功能和性能的同时,不增加瓣膜支架的纵向高度,进而降低了瓣膜支架的整体高度,进而降低介入瓣膜假体伸出长度,提高了瓣膜支架的安全型,避免了瓣膜支架对组织结构造成损伤或者堵塞左室流出道。例如,本实施例中,瓣膜支架包括过渡段40,过渡段和二尖瓣瓣环贴合,从而瓣膜支架的整体瓣下高度降低。当瓣膜支架的整体瓣下高度降低时,瓣膜支架和周围组织的干涉可能性也随之降低,从而降低损伤原生腱索或乳头肌的风险。同时瓣膜支架瓣下高度降低,也会使左室流出道堵塞的风险降低。Preferably, as shown in Figure 2, the outflow end of the outflow channel section 20 has a row of grid frames 22 distributed along the circumference of the valve stent, and the grid frames 22 are arranged in a concave hexagonal shape, so The concave angle 221 of the concave hexagon is concave along the axial direction of the valve stent toward the inflow end. This arrangement not only ensures that the valve stent can be pressed and held into the sheath, but also allows a connection structure between the rods connected to the rods on both sides of the concave angle 221 to provide structural stability of the valve stent. For example, the rods connected to the rods on both sides of the concave angle 221 are straight rods. This connection between the two straight rods ensures the stability of the structure. In addition, due to the concave corners, the concave hexagonal structure maintains the function and performance of the valve stent without increasing the longitudinal height of the valve stent, thus reducing the overall height of the valve stent and thus reducing the extension length of the interventional valve prosthesis. The safety of the valve stent is improved and the valve stent is prevented from causing damage to the tissue structure or blocking the left ventricular outflow tract. For example, in this embodiment, the valve stent includes a transition section 40 that fits the mitral valve annulus, so that the overall subvalvular height of the valve stent is reduced. When the overall subvalvular height of the valve stent is reduced, the potential for interference between the valve stent and surrounding tissue is also reduced, thereby reducing the risk of injury to the native chordae tendineae or papillary muscles. At the same time, the lower subvalvular height of the valve stent will also reduce the risk of left ventricular outflow tract obstruction.
优选的,所述流出道段20还具有支架杆23,所述支架杆23沿所述瓣膜支架的轴向延伸,所述挂耳31与所述支架杆23连接,如此可以保证挂耳31与流出道段20的连接稳定性以及轴向受力的均匀性。Preferably, the outflow channel section 20 also has a stent rod 23 extending along the axial direction of the valve stent, and the hanging ear 31 is connected to the stent rod 23, thus ensuring that the hanging ear 31 is connected to the stent rod 23. The connection stability of the outflow channel section 20 and the uniformity of axial force.
优选的,所述挂耳31包括直段杆311以及头端312,所述直段杆311沿所述瓣膜支架的轴向延伸设置,所述头端312设置于所述直段杆311的流出端,沿所述直段杆311的宽度方向,所述头端312的尺寸大于所述直段杆311的宽度。直段杆311以及头端312可以嵌入输送系统相对应形状的凹槽中,头端312在直段杆311的直段结束时产生形状变化,以此来保证当挂耳31嵌入输送系统时,瓣膜支架可以和输送系统的挂耳连接部不产生相对的轴向位移,从而瓣膜支架可以被压握收进输送系统内,也可以在释放出输送系统时,通过自身的膨胀恢复原有形状和输送系统进行分离。更佳的,所述头端312为弧线形结构或者多边形结构。例如,头端312的形状可以是圆形,椭圆形等弧线形结构,也可以是正方形,矩形,菱形等多边形结构。Preferably, the hanging ear 31 includes a straight section rod 311 and a head end 312. The straight section rod 311 extends along the axial direction of the valve stent. The head end 312 is arranged at the outflow of the straight section rod 311. Along the width direction of the straight section rod 311, the size of the head end 312 is larger than the width of the straight section rod 311. The straight section rod 311 and the head end 312 can be embedded in the groove of the corresponding shape of the conveying system. The head end 312 changes shape at the end of the straight section of the straight section rod 311 to ensure that when the hanging ear 31 is embedded in the conveying system, The valve stent can have no relative axial displacement with the hanging ear connection part of the delivery system, so the valve stent can be squeezed and retracted into the delivery system, or it can restore its original shape and shape through its own expansion when it is released from the delivery system. conveyor system for separation. More preferably, the head end 312 has an arc-shaped structure or a polygonal structure. For example, the shape of the head end 312 may be a circular, elliptical or other arc-shaped structure, or may be a square, rectangular, rhombus or other polygonal structure.
本实施例还提供一种瓣膜假体,如图4所示,所述瓣膜假体包括:瓣叶1以及如上所述的瓣膜支架;所述瓣叶与所述瓣膜支架连接。当然,所述瓣叶1可以直接连接于所述瓣膜支架上,所述瓣叶1还可以通过一瓣叶连接件2连 接于所述瓣膜支架上。例如,瓣叶连接件与瓣膜支架连接,瓣叶与瓣叶连接件连接。所述瓣膜假体例如是人工心脏瓣膜假体,用于二尖瓣以及三尖瓣等。所述瓣膜假体具备瓣膜支架所带来的有益效果,本文在此不再赘述。所述瓣膜假体的其他的结构部件可参考现有技术,本文在此不再描述。This embodiment also provides a valve prosthesis. As shown in Figure 4, the valve prosthesis includes: valve leaflets 1 and the valve stent as described above; the valve leaflets are connected to the valve stent. Of course, the leaflets 1 can be directly connected to the valve stent, and the leaflets 1 can also be connected to the valve stent through a leaflet connector 2. For example, the valve leaflet connector is connected to the valve stent, and the valve leaflets are connected to the valve leaflet connector. The valve prosthesis is, for example, an artificial heart valve prosthesis, which is used for mitral valves, tricuspid valves, etc. The valve prosthesis has the beneficial effects brought by the valve stent, which will not be described in detail here. For other structural components of the valve prosthesis, reference can be made to the prior art and will not be described here.
本实施例还提供一种瓣膜假体系统,包括:输送系统以及如上所述的瓣膜假体;所述瓣膜假体的挂耳段30嵌入所述输送系统的输送凹槽中,当释放瓣膜假体时,所述挂耳段30从所述输送凹槽中脱出。挂耳段30通过和瓣膜输送系统上的凹槽相连接,使支架可以固定在输送系统上,使支架可以经过压握后收进输送系统里,以及通过自身的扩张力,在从输送系统释放出来后,自动分离。所述瓣膜假体系统具备瓣膜假体所带来的有益效果,本文在此不再赘述。所述瓣膜假体系统的其他的结构部件可参考现有技术,本文在此不再描述。This embodiment also provides a valve prosthesis system, including: a delivery system and the valve prosthesis as described above; the hanging ear section 30 of the valve prosthesis is embedded in the delivery groove of the delivery system. When the valve prosthesis is released, When it is removed from the body, the hanging ear section 30 is protruded from the conveying groove. The ear-hanging section 30 is connected to the groove on the valve delivery system, so that the stent can be fixed on the delivery system, so that the stent can be retracted into the delivery system after being pressed, and released from the delivery system through its own expansion force. After coming out, it will be separated automatically. The valve prosthesis system has the beneficial effects brought by the valve prosthesis, which will not be described in detail here. For other structural components of the valve prosthesis system, reference can be made to the prior art and will not be described here.
综上所述,在本发明提供的一种瓣膜支架、瓣膜假体以及瓣膜假体系统中,所述瓣膜支架沿所述瓣膜支架的轴向包括依次设置的流入道段、流出道段以及挂耳段;所述流出道段具有瓣叶连接部,所述瓣叶连接部用于连接瓣叶;所述挂耳段至少包括设置于沿所述瓣叶连接部的轴向的两侧的一对挂耳,或者,所述挂耳段至少包括设置于沿所述瓣叶连接部所在的轴向延伸的位置的一挂耳。如此,使得挂耳段能够保证瓣叶连接部的受力均匀,进而提高瓣膜支架整体受力均匀,从而提高瓣膜支架压握进入输送系统的均匀性以及在释放时的精准性。To sum up, in the valve stent, valve prosthesis and valve prosthesis system provided by the present invention, the valve stent includes an inflow channel section, an outflow channel section and a hanging section along the axial direction of the valve stent. The ear segment; the outflow tract segment has a leaflet connecting portion, and the leaflet connecting portion is used to connect the leaflets; the ear hanging segment at least includes one provided on both sides along the axial direction of the leaflet connecting portion. For the hanging ear, or the hanging ear section at least includes one hanging ear arranged at a position extending along the axial direction where the leaflet connecting portion is located. In this way, the ear-hanging section can ensure uniform stress on the valve leaflet connection portion, thereby improving uniform force on the valve stent as a whole, thereby improving the uniformity of the valve stent being pressed into the delivery system and the accuracy during release.
此外还应该认识到,虽然本发明已以较佳实施例披露如上,然而上述实施例并非用以限定本发明。对于任何熟悉本领域的技术人员而言,在不脱离本发明技术方案范围情况下,都可利用上述揭示的技术内容对本发明技术方案作出许多可能的变动和修饰,或修改为等同变化的等效实施例。因此,凡是未脱离本发明技术方案的内容,依据本发明的技术实质对以上实施例所做的任何简单修改、等同变化及修饰,均仍属于本发明技术方案保护的范围。In addition, it should be recognized that although the present invention has been disclosed above in preferred embodiments, the above embodiments are not intended to limit the present invention. For any person familiar with the art, without departing from the scope of the technical solution of the present invention, they can use the technical content disclosed above to make many possible changes and modifications to the technical solution of the present invention, or modify it into equivalent changes. Example. Therefore, any simple modifications, equivalent changes and modifications made to the above embodiments based on the technical essence of the present invention without departing from the content of the technical solution of the present invention still fall within the scope of protection of the technical solution of the present invention.
Claims (10)
- 一种瓣膜支架,其特征在于,沿所述瓣膜支架的轴向包括依次设置的流入道段、流出道段以及挂耳段;A valve stent, characterized in that, along the axial direction of the valve stent, it includes an inflow channel section, an outflow channel section and a hanging ear section arranged in sequence;所述流出道段具有瓣叶连接部,所述瓣叶连接部用于连接瓣叶;The outflow tract section has a leaflet connecting portion, and the leaflet connecting portion is used to connect the leaflets;所述挂耳段至少包括设置于沿所述瓣叶连接部的轴向的两侧的一对挂耳,或者,所述挂耳段至少包括设置于沿所述瓣叶连接部所在的轴向延伸的位置的一挂耳。The hanging ear section at least includes a pair of hanging ears provided on both sides along the axial direction of the leaflet connecting portion, or the hanging ear section at least includes a pair of hanging ears provided along the axial direction of the leaflet connecting portion. One hanging ear in the extended position.
- 根据权利要求1所述的瓣膜支架,其特征在于,所述挂耳段包括的所述挂耳的数量为所述瓣叶连接部的数量的双数倍,沿每个所述瓣叶连接部的轴向的两侧对称设置有一对所述挂耳。The valve stent according to claim 1, wherein the number of the hanging ears included in the hanging ear section is an even multiple of the number of the leaflet connecting portions, and the number of the hanging ears along each of the leaflet connecting portions is A pair of the hanging lugs are symmetrically arranged on both sides in the axial direction.
- 根据权利要求1所述的瓣膜支架,其特征在于,所述挂耳段包括的所述挂耳的数量为所述瓣叶连接部的数量的单数倍,沿每个所述瓣叶连接部所在的轴向延伸的位置设置有一个所述挂耳。The valve stent according to claim 1, wherein the number of the hanging ears included in the hanging ear section is an odd multiple of the number of the leaflet connecting portions, and the number of the hanging ears along each of the leaflet connecting portions is One of the hanging ears is provided at an axially extending position.
- 根据权利要求1所述的瓣膜支架,其特征在于,所述挂耳段包括的所述挂耳的数量为所述瓣叶连接部的数量的非单数倍以及非双数倍,部分的所述挂耳设置于沿所述瓣叶连接部所在的轴向延伸的位置,其余的所述挂耳设置于沿所述瓣叶连接部的轴向相对称的两侧。The valve stent according to claim 1, characterized in that the number of the hanging ears included in the hanging ear section is not an odd multiple and a non-even multiple of the number of the leaflet connecting parts, and part of the The hanging lugs are arranged at a position extending along the axial direction of the leaflet connecting portion, and the remaining hanging lugs are arranged on both sides that are symmetrical along the axial direction of the leaflet connecting portion.
- 根据权利要求1所述的瓣膜支架,其特征在于,所述流出道段具有多个所述瓣叶连接部,沿每个所述瓣叶连接部的轴向的两侧对称设置一对挂耳,每一对所述挂耳形成一挂耳组件,多个所述挂耳组件沿所述瓣膜支架的周向均匀分布;The valve stent according to claim 1, wherein the outflow channel section has a plurality of leaflet connecting portions, and a pair of hanging ears are symmetrically arranged along both sides of the axial direction of each leaflet connecting portion. , each pair of the hanging ears forms a hanging ear assembly, and a plurality of the hanging ear assemblies are evenly distributed along the circumferential direction of the valve stent;或者,所述流出道段具有多个所述瓣叶连接部,沿每个所述瓣叶连接部所在的轴向延伸的位置设置一个所述挂耳,多个所述挂耳沿所述瓣膜支架的周向均匀分布。Alternatively, the outflow passage section has a plurality of leaflet connecting portions, one hanging ear is provided along the axially extending position of each leaflet connecting portion, and a plurality of hanging ears are arranged along the valve leaflet connecting portion. The stent is evenly distributed circumferentially.
- 根据权利要求1所述的瓣膜支架,其特征在于,所述流出道段的流出端具有一排沿所述瓣膜支架的周向分布的网格架,每个所述网格架呈凹六边形设置,所述凹六边形的凹角沿所述瓣膜支架的轴向朝向流入端的方向内凹。The valve stent according to claim 1, wherein the outflow end of the outflow channel section has a row of grid frames distributed along the circumference of the valve stent, and each of the grid frames has a concave hexagonal shape. It is arranged in a shape, and the concave corners of the concave hexagon are concave along the axial direction of the valve stent toward the inflow end.
- 根据权利要求1所述的瓣膜支架,其特征在于,所述流出道段还具有支架杆,所述支架杆沿所述瓣膜支架的轴向延伸,所述挂耳与所述支架杆连接。The valve stent according to claim 1, wherein the outflow channel section further has a stent rod, the stent rod extends along the axial direction of the valve stent, and the hanging ear is connected to the stent rod.
- 根据权利要求1所述的瓣膜支架,其特征在于,所述挂耳包括直段杆以及头端,所述直段杆沿所述瓣膜支架的轴向延伸设置,所述头端设置于所述直段杆的流出端,沿所述直段杆的宽度方向,所述头端的尺寸大于所述直段杆的宽度;所述头端为弧线形结构或者多边形结构。The valve stent according to claim 1, wherein the hanging ear includes a straight section rod and a head end, the straight section rod extends along the axial direction of the valve stent, and the head end is provided on the valve stent. At the outflow end of the straight section rod, along the width direction of the straight section rod, the size of the head end is larger than the width of the straight section rod; the head end is an arc-shaped structure or a polygonal structure.
- 一种瓣膜假体,其特征在于,所述瓣膜假体包括:瓣叶以及根据权利要求1-8中任一项所述的瓣膜支架;A valve prosthesis, characterized in that the valve prosthesis includes: a valve leaflet and a valve stent according to any one of claims 1 to 8;所述瓣叶与所述瓣膜支架连接。The valve leaflets are connected to the valve stent.
- 一种瓣膜假体系统,其特征在于,包括:输送系统以及根据权利要求9所述的瓣膜假体;A valve prosthesis system, characterized by comprising: a delivery system and the valve prosthesis according to claim 9;所述瓣膜假体的挂耳段嵌入所述输送系统的输送凹槽中,当释放瓣膜假体时,所述挂耳段从所述输送凹槽中脱出。The hanging ear section of the valve prosthesis is embedded in the delivery groove of the delivery system, and when the valve prosthesis is released, the hanging ear section comes out of the delivery groove.
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US20200093590A1 (en) * | 2018-09-20 | 2020-03-26 | St. Jude Medical, Cardiology Division, Inc. | Attachment of Leaflets to Prosthetic Heart Valve |
CN111184596A (en) * | 2020-02-18 | 2020-05-22 | 科凯(南通)生命科学有限公司 | Artificial heart valve |
CN111714250A (en) * | 2019-03-22 | 2020-09-29 | 上海微创心通医疗科技有限公司 | Heart valve support and prosthesis thereof |
CN212415992U (en) * | 2020-09-28 | 2021-01-29 | 上海微创心通医疗科技有限公司 | Artificial heart valve leaflet and heart valve prosthesis |
CN113679510A (en) * | 2020-05-19 | 2021-11-23 | 上海微创心通医疗科技有限公司 | Heart valve prosthesis and stent and replacement system thereof |
CN114073603A (en) * | 2020-08-20 | 2022-02-22 | 先健科技(深圳)有限公司 | Valve support and artificial heart valve |
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2022
- 2022-04-29 CN CN202210468853.2A patent/CN116999207A/en active Pending
- 2022-06-01 WO PCT/CN2022/096675 patent/WO2023206709A1/en unknown
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US20200093590A1 (en) * | 2018-09-20 | 2020-03-26 | St. Jude Medical, Cardiology Division, Inc. | Attachment of Leaflets to Prosthetic Heart Valve |
CN111714250A (en) * | 2019-03-22 | 2020-09-29 | 上海微创心通医疗科技有限公司 | Heart valve support and prosthesis thereof |
CN111184596A (en) * | 2020-02-18 | 2020-05-22 | 科凯(南通)生命科学有限公司 | Artificial heart valve |
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