WO2023206708A1 - Prothèse valvulaire - Google Patents

Prothèse valvulaire Download PDF

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Publication number
WO2023206708A1
WO2023206708A1 PCT/CN2022/096674 CN2022096674W WO2023206708A1 WO 2023206708 A1 WO2023206708 A1 WO 2023206708A1 CN 2022096674 W CN2022096674 W CN 2022096674W WO 2023206708 A1 WO2023206708 A1 WO 2023206708A1
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WO
WIPO (PCT)
Prior art keywords
valve
leaflet
stent
leaflets
rod
Prior art date
Application number
PCT/CN2022/096674
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English (en)
Chinese (zh)
Inventor
邱尧
刘世红
陈国明
Original Assignee
上海微创心通医疗科技有限公司
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Publication date
Application filed by 上海微创心通医疗科技有限公司 filed Critical 上海微创心通医疗科技有限公司
Publication of WO2023206708A1 publication Critical patent/WO2023206708A1/fr

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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
    • 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 prosthesis.
  • 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. Due to the complexity of the structure of the native valve, the design of artificial valves is very difficult.
  • the artificial valves may be, for example, aortic valves, pulmonary valves, tricuspid valves, or mitral valves. Take the mitral valve as an example to illustrate its characteristics: 1.
  • the area of the mitral valve annulus is large and the leaflets are difficult to close: the artificial valve prosthesis has certain requirements for the contact area of the valve leaflets after closure, and sufficient leaflets
  • the contact area can effectively prevent blood reflux and large transvalvular pressure difference. Transvalvular pressure difference is the most important hemodynamic parameter for evaluating the function of artificial heart valves.
  • the connection between the valve leaflets and the stent is poor: Compared with surgical operations, artificial valves for interventional surgeries generally use self-expanding or ball-expanding stents. The mechanical properties of the stent are relatively poor, which will affect the valve leaflets and the stent. The connection of the stent, in turn, affects the stability of the valve.
  • Some designs enhance the connection between the valve leaflets and the stent by adding additional structures to the stent, which will cause stress concentration on the valve leaflets, and in severe cases, damage to the valve leaflets. Some designs increase the connection strength between the valve leaflets and the stent by changing the original structure of the stent, which will adversely affect the mechanical properties of the stent itself. 3. Due to the complex environment in the body, the structural stability of the artificial valve is required to be high: the native annulus of the mitral valve is saddle-shaped, and the contraction and relaxation shapes are uneven, so the working condition of the artificial valve in the body is unstable. In addition, there are many other structures near the native structure of the mitral valve, such as papillary muscles, chordae tendineae, ventricular walls, etc. These structures will affect the shape and range of motion of the artificial valve in the body.
  • the purpose of the present invention is to provide a valve prosthesis to solve the problems in current valve prostheses of high difficulty in closing the valve leaflets, poor connection stability between the valve leaflets and the stent, and poor stability of the valve prosthesis under complex working conditions.
  • the present invention provides a valve prosthesis, including: a valve stent, a valve leaflet, and a valve leaflet connector;
  • the valve stent has a stent rod;
  • the valve leaflet connector includes a folded portion and a pair of connecting portions , the folded part is used to fold in half and accommodate the stent rod; the two ends of the folded part are respectively extended with a pair of connecting parts, and the leaflets are connected to the connecting parts, so that the leaflets It is connected to the stent rod through the leaflet connecting piece.
  • the leaflet connecting member includes a flexible sheet-like structure made of pericardial tissue and/or polymer braid.
  • the flexible sheet-like structure is made of the pericardial tissue and the polymer braid, and the pericardial tissue and the polymer braid are laminated, or the pericardial tissue is covered with the polymer braid. Beyond the molecular braid.
  • the leaflet connecting member includes a hard structure, the cross section of the hard structure along the direction of accommodating the stent rod is U-shaped.
  • valve stent is integrally formed, the stent rod includes a straight rod, and the folded portion is provided on the straight rod.
  • the stent rod includes an engaging portion for engaging and fixing the position of the leaflet connecting member.
  • the engaging portion is a protrusion, and the protrusion extends along the circumferential direction of the valve stent.
  • the leaflets include a leaflet body and a leaflet engaging portion, the leaflet engaging portion is connected to the leaflet body, and the leaflet engaging portions are provided along both ends of the folded portion. Between the pair of connecting portions respectively extending, the connecting portion is sutured to the leaflet abutting portion.
  • the valve prosthesis includes multiple leaflets and multiple leaflet connectors
  • the valve stent has multiple stent rods
  • the folded portion of each valve leaflet connector accommodates one of the stent rods.
  • each pair of connecting portions connects two adjacent leaflets.
  • the valve prosthesis includes three valve leaflet connectors.
  • a valve prosthesis in a valve prosthesis, it includes: a valve stent, a valve leaflet, and a valve leaflet connector;
  • the valve stent has a stent rod;
  • the valve leaflet connector includes a folded portion and a pair of connecting portions, and the valve leaflet connector includes a folded portion and a pair of connecting portions.
  • the folded part is used to fold in half and accommodate the stent rod; the two ends of the folded part are respectively extended with a pair of connecting parts, and the leaflets are connected to the connecting parts, so that the leaflets pass through the The leaflet connecting piece is connected with the stent rod.
  • Such an arrangement improves the closure of the valve leaflets, improves the connection stability between the valve leaflets and the valve stent, and improves the overall stability of the valve prosthesis under complex working conditions. In addition, it also avoids calcification of the valve leaflets due to stress concentration, reducing the risk of stress concentration on the valve leaflets and damage to the valve leaflets.
  • Figure 1 is a schematic diagram of a valve prosthesis according to an embodiment of the present invention.
  • Figure 2 is a schematic diagram of the valve prosthesis from another angle according to an embodiment of the present invention.
  • FIG. 3 is a partial enlarged view of the leaflet connecting member described in FIG. 1 .
  • Figure 4 is a schematic diagram of the valve prosthesis from another angle according to an embodiment of the present invention.
  • Figure 5 is a schematic diagram of a leaflet connector according to an embodiment of the present invention.
  • FIG. 6 is a schematic diagram of another valve leaflet connector according to an embodiment of the present invention.
  • Figure 7 is a schematic diagram of a bracket rod according to an embodiment of the present invention.
  • Figure 8 is a schematic diagram of the tiling of valve leaflets according to an embodiment of the present invention.
  • Figure 9 is a schematic diagram of another type of tiling of valve leaflets according to an embodiment of the present invention.
  • 1-valve stent 11-inflow channel, 12-transition section, 13-outflow channel, 14-stent rod, 141-engaging part, 142-straight rod;
  • 3-leaf connecting piece 31-folded part, 32-connecting part, 321-first connecting part, 322-second connecting part.
  • valve refers to the artificial valve prosthesis, including at least the stent, leaflets and the connection between the two. If there is a skirt, Also includes hem.
  • skirt refers to the collection of all leaflets on the artificial valve prosthesis.
  • the “leaf” mentioned in this specification refers to one of the “leaves”.
  • inner, outer, outer, upper, “lower” and similar expressions used herein are for illustrative purposes only and do not represent the only embodiment.
  • axial used herein refers to the stent. The direction of the axis.
  • 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 examples, some technical features that are well known in the art are not described in order to avoid confusion with the present invention.
  • An embodiment of the present invention provides a valve prosthesis, including: a valve stent, a valve leaflet, and a valve leaflet connector; the valve stent has a stent rod; the valve leaflet connector includes a folded portion and a pair of connecting portions, and the valve leaflet connector includes a folded portion and a pair of connecting portions.
  • the folded part is used to fold in half and accommodate the stent rod; the two ends of the folded part are respectively extended with a pair of connecting parts, and the leaflets are connected to the connecting parts, so that the leaflets pass through the The leaflet connecting piece is connected with the stent rod.
  • Such an arrangement improves the closure of the valve leaflets, improves the connection stability between the valve leaflets and the valve stent, and improves the overall stability of the valve prosthesis under complex working conditions. In addition, it also avoids calcification of the valve leaflets due to stress concentration, reducing the risk of stress concentration on the valve leaflets and damage to the valve leaflets.
  • valve prosthesis which can be applied to the mitral valve, and can also be applied to other valves besides the mitral valve, for example, can be applied to the aortic valve, pulmonary valve, or triple valve. cusps etc.
  • the valve prosthesis includes: a valve stent 1 , a valve leaflet 2 and a valve leaflet connector 3 .
  • the valve stent 1 has a stent rod 14 .
  • the valve stent 1 has three parts, namely an inflow channel 11, an outflow channel 13 and a transition section 12.
  • the inflow channel 11, the transition section 12 and the outflow channel 13 are connected in sequence in the axial direction. According to the direction of blood flow, the outflow channel 13 is located into the downstream of channel 11.
  • the inflow channel 11 corresponds to the part where the blood flows into the valve stent 1 when the valve prosthesis is operated
  • the outflow channel 13 corresponds to the part where the blood flows out of the valve stent 1 when the valve prosthesis is operated.
  • the valve stent 1 includes grid units connected by stent rods 14 .
  • the grid units can be rhombus or other suitable shapes, such as pentagons, hexagons, etc. that can form closed-shaped units.
  • the valve stent 1 is made of shape memory alloy material, preferably nickel-titanium metal material.
  • the valve prosthesis may also include a skirt (not shown).
  • the leaflets 2 are arranged inside the valve stent 1 and the skirt, and are fixed to the valve stent 1 and the skirt by suturing.
  • the material of the valve leaflets 2 is generally biological material or polymer material, preferably biological material, more preferably bovine pericardium or porcine pericardium material.
  • the valve leaflets 2 include at least two, and the number of the valve leaflets 2 is preferably three, evenly distributed in the circumferential direction of the valve stent 1 .
  • the valve leaflet 2 acts as a one-way valve by opening and closing. Specifically, when the valve leaflet 2 opens, the blood from the left atrium can flow into the left ventricle. When the valve leaflet 2 closes, Blood from the left ventricle cannot flow into the left atrium.
  • the skirt is generally made of polymer material, and the skirt can prevent paravalvular leakage, facilitate endothelialization after valve implantation, and improve the stability of the valve prosthesis.
  • the skirt can adopt a one-piece structure or a multi-piece combined structure, and the shape can be adjusted according to needs, and this embodiment is not particularly limited.
  • the leaflet connector 3 includes a folded portion 31 and a connecting portion 32.
  • the folded portion 31 is used to fold in half and accommodate the stent rod 14, so that the stent rod 14 can be wrapped to
  • the folding angle of the folding portion 31 enables a stable connection between the folding portion 31 and the bracket rod 14 .
  • the connecting parts 32 are respectively extended from both ends of the folded part 31, and the connecting parts 32 are connected to the leaflets 2, so that the leaflets 2 are connected to the bracket rod 14 through the leaflet connector 3. connect. Because in the current technology, the valve leaflets 2 need to be directly connected to the valve stent 1 through sutures, on the one hand, the sutures are easy to break, and on the other hand, the stress on the sutures of the valve leaflets is also very large.
  • the connecting part 32 is divided into a first connecting part 321 and a second connecting part 322 , and the first connecting part 321 and the second connecting part 322 are respectively formed along the folded part 31 Extended settings at both ends.
  • the valve leaflet connector 3 serves as the connecting medium between the valve leaflet 2 and the valve stent 1.
  • the valve leaflet 2 is not directly connected to the valve stent 1, thus avoiding the use of sutures to be directly wound on the valve stent 1.
  • the leaflet connector 3 is directly connected to the valve stent 1.
  • the leaflet connector 3 bears the main force when the leaflet 2 is opened or closed, avoiding the calcification of the leaflet 2 due to stress concentration and reducing the risk of the leaflet 2. Risk of stress concentration and damage to leaflets 2.
  • the valve leaflet connector 3 can adjust its size according to the length of the stent rod 14 to which it is to be connected, thereby improving the overall matching of the valve stent 1.
  • the shape and size of the leaflet connector 3 can be adjusted through design to control the open or closed form of the leaflet 2. More specifically, the height of the leaflet connector 3 can be changed to control two adjacent leaflets.
  • the connection height of 2 is used to control the closed form of the leaflets 2.
  • the area and shape of the leaflet connector 3 are used to control the connection area of the leaflets 2, thereby controlling the open form of the leaflets 2.
  • the leaflet connecting member 3 includes a flexible sheet-like structure made of pericardial tissue and/or polymer braid.
  • the flexible sheet structure means that the leaflet connector 3 can be bent during installation and connection.
  • the bent flexible sheet structure can form a U-shaped structure.
  • the U-shaped sheet structure bypasses the bracket rod 14 to connect the bracket.
  • the rod 14 is wrapped therein to realize the connection between the leaflet connector 3 and the bracket rod 14 .
  • the pericardial tissue is, for example, bovine pericardium or porcine pericardium material, thereby improving the biocompatibility of the valve prosthesis and the compatibility of the valve leaflet connector 3 and the valve leaflet 2 .
  • the leaflets 2 are preferably pericardial tissue.
  • the leaflets 2 and the leaflet connector 3 are made of the same material with the same hardness and toughness and will not damage the leaflets.
  • the polymer braid is, for example, a woven soft cloth, which has higher strength than the pericardial tissue and can improve the connection strength between the valve leaflet connector 3 and the valve stent 1 .
  • the size of the flexible sheet structure can be set according to actual needs. For example, the flexible sheet structure can be cut into the required shape, such as rectangle, circle, oval or trapezoid, etc., as long as it can be folded in half. .
  • the pericardial tissue and the polymer braid are laminated and stitched or bonded. set, or the pericardial tissue is wrapped outside the polymer braid.
  • the lamination of the pericardial tissue and the polymer braid has three layers. These three layers are preferably in a stitched arrangement. In other embodiments, these three layers may also be bonded. More preferably, the stacked layers are arranged to achieve a tight combination of the pericardial tissue and the polymer braid through suturing or bonding. The bonding may be achieved using biological glue, for example.
  • the polymer braid is arranged in the middle layer, and the pericardial tissue is arranged in the outer layer.
  • the pericardial tissue is completely covered outside the polymer braid, such as a core-shell structure, and the polymer braid is located at the core of the core-shell structure, that is, located at the core of the pericardial tissue.
  • the pericardial tissue is located in the shell part of the core-shell structure, that is, located outside the polymer braid. In this way, the leaflet connecting member 3 has both the strength of the polymer braid and the biocompatibility of the pericardial tissue.
  • valve leaflet connector 3 of the polymer braid is not easily deformed, ensuring that the relative position between adjacent valve leaflets 2 does not change. Changes, improve the structural stability of the valve leaflet closure and the closed shape of the valve leaflet 2, avoid valve regurgitation or stress concentration of the valve leaflet 2, thereby improving the stability of the valve stent, maintaining the long-term opening and closing functionality of the valve, thereby bringing for better valve durability.
  • the pericardial tissue is arranged on the outside and is directly connected to the valve leaflet 2, thereby improving the compatibility between the valve leaflet connector 3 and the valve leaflet 2.
  • the leaflet connecting member 3 includes a hard structure, which can provide stronger structural strength and improve the connection strength.
  • the hard structure has a U-shaped cross section along the direction of accommodating the bracket rod. More specifically, the cross section of the hard structure along the radial direction of the valve stent is arranged in a U-shape.
  • the hard structure is, for example, a polymer hard sheet or a metal hard sheet with a certain thickness, which is obtained by bending.
  • the folded portion 31 is stuck on the stent rod 14, and the connecting portion 32 preferably clamps the two adjacent leaflets 2. .
  • holes can also be drilled in the connection portion 32 of the polymer hard sheet or the metal hard sheet, so that the valve leaflet connector 3 and the valve leaflets 2 are sewn together, and then the valve stent 1 and the valve leaflets 2 are connected together.
  • the valve stent adopts an integrated structure
  • the stent rod 14 includes a straight rod 142
  • the folded portion 31 is provided on the straight rod 142 .
  • the straight rod 142 is, for example, a straight rod extending along the axial direction of the valve stent.
  • the straight rod 142 can reduce the impact caused by the stent rod 14 when connected to the leaflet connector 3. The additional stress increases the connection strength of the leaflet connector 3.
  • the valve stent includes an integrally designed straight rod.
  • the design of the integrated straight rod does not require adding additional structures to the grid stent structure, such as openings, grooves and other structures, and will not affect the The overall mechanical properties of the stent are improved, and there is no need to add additional structures and the width of the stent at this location will not be increased, thereby achieving the purpose of reducing the circumferential volume of the stent, thereby significantly reducing the profile value of the valve stent 1.
  • the number of straight rods 142 is no less than the number of leaflet connectors 3 .
  • the straight rod 142 is preferably 4-10 mm in length and less than 2 mm in width.
  • the leaflet connector 3 is provided at the straight rod 142, so that the folded portion 31 of the leaflet connector 3 is evenly stressed, ensuring the connection stability of the leaflet connector 3.
  • the bracket rod 14 includes an engaging portion 141 for engaging and fixing the position of the leaflet connector 3 to prevent the leaflet connector 3 from moving or slipping on the bracket rod 14 .
  • the engaging portion 141 is a protrusion, and the protrusion extends along the circumferential extension direction of the valve stent 1 .
  • the protrusions can catch the upper end and/or the lower end of the folded portion of the leaflet connector 3.
  • the protrusions match the size of the leaflet connector 3 to prevent the leaflet connector 3 from moving on the straight rod, thereby preventing the movement of the leaflet connector 3 on the straight rod.
  • the displacement of the leaflet connector 3 on the stent rod 14 can effectively control the adjacent leaflets 2 to maintain a consistent shape regardless of whether they are open or closed, and avoid the uneven height of the adjacent leaflets 2.
  • the resulting damage to the closing or opening function improves the stability of the position of the valve leaflets 2 and improves the stability of the valve in motion.
  • the protrusion of the engaging portion 141 may also extend along the radial direction of the valve stent 1 .
  • the engaging portion 141 may also be a barb, and the barb penetrates into the leaflet connecting member 3 to achieve connection.
  • the engaging portion 141 may also be of another structure with relatively high friction, such as a fine thread-shaped structure.
  • the leaflet 2 includes a leaflet body 21 and a leaflet engaging portion 22 , and the leaflet engaging portion 22 is connected to the leaflet body 21 .
  • the leaflet engaging portion 22 is used to be disposed between the two connecting portions 32 respectively extending along both ends of the folded portion 31 , and the connecting portion 32 is sutured and connected to the leaflet engaging portion 22 . That is, the leaflet engaging portion 22 is sandwiched between the two connecting portions 32 .
  • the first connecting portion 321 and the second connecting portion 322 are two connecting portions 32 extending from both ends of the folded portion 31 .
  • the leaflet engaging portion 22 may protrude from the leaflet body 21 .
  • the protruding shape is, for example, a sheet-like structure, which facilitates clamping into the leaflet connector 3.
  • the sheet-shape is, for example, a rectangular sheet, and of course, it can also be in other shapes.
  • the leaflet abutting portion 22 can be directly provided on the leaflet body 21 without protruding.
  • each leaflet connecting member 3 accommodates one of the stent rods 14 , and the connecting portion 32 connects two adjacent leaflets 2 , so that the two adjacent leaflets 2 are connected to each other.
  • the tight connection between the leaflets 2 also makes the connection strength between the two adjacent leaflets 2 consistent, which reduces the difficulty of closing the leaflets 2 and improves the stability of the closure of the leaflets 2.
  • the valve prosthesis includes three valve leaflet connectors 3 .
  • the number of leaflets 2 is three, and the three leaflet connectors 3 connect the three leaflets 2 in pairs, thereby improving the connection strength and connection stability of the leaflets 2 and ensuring that The closure stability of valve leaflet 2 is improved.
  • the present invention provides a valve prosthesis, which includes: a valve stent, a valve leaflet, and a valve leaflet connector; the valve stent has a stent rod; and the valve leaflet connector includes a folded portion and a pair of valve leaflet connectors.
  • a connecting part, the folded part is used to fold in half and accommodate the stent rod; a pair of connecting parts are respectively extended from both ends of the folded part, and the leaflets are connected to the connecting part, so that the The leaflets are connected to the stent rod through the leaflet connecting piece.

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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

Prothèse valvulaire, comprenant un stent de valve (1), des feuillets de valve (2) et des éléments de liaison de feuillet de valve (3). Le stent de valve (1) est pourvu d'une tige de stent (14). Chaque élément de liaison de feuillet de valve (3) comprend une partie pliée (31) et une paire de parties de liaison (32). Chaque partie pliée (31) est utilisée pour être pliée et recevoir la tige de stent (14). Deux extrémités de chaque partie pliée (31) s'étendent pour être pourvues de la paire de parties de liaison (32), respectivement. Les feuillets de valve (2) sont reliés aux parties de liaison (32), de telle sorte que les feuillets de valve (2) sont reliés à la tige de stent (14) au moyen des éléments de liaison de feuillet de valve (3). De cette manière, le degré de fermeture des feuillets de valve (2) est amélioré, la stabilité de connexion entre les feuillets de valve (2) et le stent de valve (1) est améliorée et, dans des conditions de travail complexes, la stabilité globale de la prothèse de valve est améliorée.
PCT/CN2022/096674 2022-04-29 2022-06-01 Prothèse valvulaire WO2023206708A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202210468878.2A CN116999208A (zh) 2022-04-29 2022-04-29 瓣膜假体
CN202210468878.2 2022-04-29

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WO2023206708A1 true WO2023206708A1 (fr) 2023-11-02

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PCT/CN2022/096674 WO2023206708A1 (fr) 2022-04-29 2022-06-01 Prothèse valvulaire

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CN (1) CN116999208A (fr)
WO (1) WO2023206708A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
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