WO2023213107A1 - Valve anchoring member and valve system - Google Patents

Valve anchoring member and valve system Download PDF

Info

Publication number
WO2023213107A1
WO2023213107A1 PCT/CN2023/075373 CN2023075373W WO2023213107A1 WO 2023213107 A1 WO2023213107 A1 WO 2023213107A1 CN 2023075373 W CN2023075373 W CN 2023075373W WO 2023213107 A1 WO2023213107 A1 WO 2023213107A1
Authority
WO
WIPO (PCT)
Prior art keywords
valve
valve anchor
elastic wire
anchor
cavity
Prior art date
Application number
PCT/CN2023/075373
Other languages
French (fr)
Chinese (zh)
Inventor
何东
马康玲
刘祥
魏勇强
Original Assignee
上海臻亿医疗科技有限公司
江苏臻亿医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 上海臻亿医疗科技有限公司, 江苏臻亿医疗科技有限公司 filed Critical 上海臻亿医疗科技有限公司
Publication of WO2023213107A1 publication Critical patent/WO2023213107A1/en

Links

Classifications

    • 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
    • A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Definitions

  • the present invention relates to the technical field of medical devices, and in particular to a valve anchor and a valve system.
  • Transcatheter mitral valve replacement surgery uses a catheter intervention method to compress the artificial heart valve into the delivery system outside the body and then deliver it to the human mitral valve annulus.
  • the artificial heart valve is released and fixed on the mitral valve.
  • the native valve leaflets are replaced at the valve annulus.
  • mitral valve replacement surgery does not require extracorporeal circulation auxiliary devices, has less trauma, and the patient recovers quickly.
  • the patient's hemodynamic index can be significantly improved after surgery.
  • the atrial septal route implantation through the femoral vein is more convenient. It is less invasive and has a wider audience.
  • the traditional anchoring method mainly fixes the artificial heart valve by designing anchoring spines to grasp the native valve leaflets, or fixing the artificial heart valve by over-sizing the artificial heart valve. Both anchoring methods can easily cause damage to the native valve leaflets or compression of the native valve annulus tissue, thus adversely affecting the patient's recovery.
  • the existing technology also adopts a design that separates the anchor from the artificial heart valve.
  • the artificial heart valve is composed of an anchoring ring and a valve body.
  • This design of separating the anchoring ring and the valve body can effectively avoid compression of the native valve annulus and is not easily damaged.
  • the native leaflets also reduce the size of each part of the delivery system, which is more conducive to the movement of the delivery system in the body.
  • the anchoring ring and the valve body are delivered separately.
  • the process of releasing the anchor ring by the anchor ring delivery system is complicated. First, the anchor ring delivery system needs to release the rope loop structure in the ventricle to capture the end of the guide wire so that the guide wire forms a guide coil, and then it can be implanted along the guide coil.
  • Anchor ring At the same time, the end of the anchor ring must be specially designed with a docking fastening device so that the anchor ring forms a closed ring structure.
  • the artificial heart valve has a waist-shaped structure (that is, convex at both ends and concave in the middle)
  • the mutual positions of the artificial heart valve and the anchoring ring need to be adjusted multiple times so that the anchoring ring can fit into the artificial heart valve.
  • the recess of the heart valve will increase the difficulty and complexity of the artificial heart valve implantation operation and place high requirements on the operator's proficiency.
  • the long operation time will also have adverse effects on the patient's health. beneficial impact.
  • the purpose of the present invention is to provide a valve anchor and a valve system that can accurately surround the native valve leaflets with the cooperation of elastic wires and traction bodies, thereby simplifying the implantation steps of the valve anchor and reducing the cost of implantation. Difficulty.
  • the present invention provides a valve anchor, which has a contracted state and an expanded state and can be switched between the contracted state and the expanded state;
  • the valve anchor includes an elastic wire, an accommodating part and a traction body; the accommodating part is arranged outside the elastic wire and connected to the elastic wire; the accommodating part extends along the elastic wire Directionally distributed and with cavities;
  • the traction body is partially disposed in the cavity of the accommodating part, and is divided into two parts after the end of the accommodating part corresponding to the distal end of the elastic wire is wound into a closed loop, and the two parts Extends along the axis of the accommodation part in the accommodation part, and the two ends of the traction body extend out of the accommodation part at the end of the accommodation part corresponding to the proximal end of the elastic wire. part; the traction body can be pulled to control the movement direction of the distal end of the valve anchor.
  • the valve anchor is in a spiral shape and has an annular inner cavity for accommodating an artificial heart valve; the valve anchor can adapt to the outside of the expanded artificial heart valve when deformed by force. Contours to exert anchoring forces on the prosthetic heart valve.
  • the valve anchor in the expanded state, has an anchoring section for surrounding the native valve leaflet, the anchoring section has at least one turn of coil, and the valve anchor also has an axis with the anchoring section.
  • the radius of curvature of the grabbing section is greater than the radius of curvature of the anchoring section, so that when the valve anchor is implanted, it moves along the cavity wall of the predetermined cavity and expands to shape.
  • the accommodating part is provided with a plurality of independently arranged cavities for the traction body to pass through. After one of the traction bodies passes through one of the cavities, the accommodating part corresponds to the corresponding cavity. The distal end of the elastic wire is bent and then penetrates into the other cavity.
  • the number of the traction bodies is one, and the accommodation part includes two hollow traction bodies arranged side by side.
  • Cavity tubes two of the cavity tubes are arranged parallel to the elastic wire, the two cavity tubes are connected to each other and/or to the elastic wire, each of the cavity tubes has one of the hollow tubes cavity, so that two parts of one said traction body are respectively inserted into two said hollow tubes.
  • the number of the traction bodies is two, and the accommodation part includes four hollow tubes distributed sequentially along the circumferential direction of the elastic wire, and the four hollow tubes are all parallel to the elastic wire. It is arranged that four of the hollow tubes are connected to each other and/or to the elastic wire, and each of the hollow tubes has one of the hollow cavities, so that two parts of each of the traction bodies are respectively threaded through in the corresponding two hollow tubes.
  • the distal end of the accommodating portion is sealed.
  • the shape of the distal end of the accommodating portion is spherical, conical or elliptical.
  • the accommodating portion includes a plurality of accommodating structures spaced apart along the extension direction of the elastic wire, each of the accommodating structures having at least two through holes arranged side by side along the radial direction of the elastic wire,
  • the through holes of all the accommodation structures form at least two cavities.
  • the present invention also provides a valve system, which includes an artificial heart valve and any one of the valve anchors, and the artificial heart valve is used to be accommodated in the valve anchor.
  • the valve anchor has a contracted state and an expanded state, and can switch between the contracted state and the expanded state;
  • the valve anchor includes elastic wire, accommodating part and traction body;
  • the accommodating part is arranged outside the elastic wire and connected with the elastic wire;
  • the accommodating part is distributed along the extension direction of the elastic wire and has a cavity;
  • the traction body is partially disposed in the cavity of the accommodating part, and is divided into two parts after the end of the accommodating part corresponding to the distal end of the elastic wire is wound into a closed loop.
  • the inside of the accommodating part extends along the axis of the accommodating part, and the two ends of the traction body extend out of the accommodating part at the end of the accommodating part corresponding to the proximal end of the elastic wire;
  • the traction body can be pulled to control the moving direction of the distal end of the valve anchor.
  • the valve anchor can also control the moving direction (including the direction of the distal end) of the distal end of the valve anchor through its own traction body during the expansion process, which can ensure that the distal end of the valve anchor can Always moving along the wall of a predetermined chamber (such as the ventricle) also allows the valve anchor to move without being disturbed by the cyclic movement of the heart and always parallel to the native valve annulus, thereby ensuring that the valve anchor can move after full expansion.
  • a predetermined chamber such as the ventricle
  • the valve system includes a prosthetic heart valve and a valve anchor for receipt in the valve anchor.
  • the valve system does not need a rope structure to capture the guide wire, and when the valve anchor is in a spiral shape, there is no need to design a docking fastening device on the valve anchor, which can simplify the implantation process of the valve anchor. Reducing the difficulty of implanting valve anchors can also improve the success rate of artificial heart valve implantation, which in turn can reduce harm to patients and facilitate their postoperative recovery.
  • the valve anchor preferably has an anchoring section, and the anchoring section can realize the connection between the artificial heart valve and the anchoring section through an interference fit between the inner cavity and the artificial heart valve, and exert an anchoring force on the artificial heart valve.
  • the traction body is withdrawn, and the valve anchor can adapt to the external contour of the artificial heart valve, so that the artificial heart valve can be fixed in a predetermined object through the valve anchor.
  • Figure 1 is a schematic structural diagram of a valve anchor in a preferred embodiment of the present invention
  • Figure 2 is a partial structural schematic diagram of a valve anchor in another preferred embodiment of the present invention.
  • Figure 3 is a schematic structural diagram of a valve anchor in another preferred embodiment of the present invention.
  • Figure 4 is a schematic structural diagram of a valve anchor in another preferred embodiment of the present invention.
  • Figure 5 is a schematic diagram of the use scene of the valve anchor in the early stage of release in a preferred embodiment of the present invention
  • Figure 6 is a schematic diagram of a usage scenario in which the valve anchor moves toward the apex direction in a preferred embodiment of the present invention
  • Figure 7 shows a usage scenario of the valve anchor surrounding the native valve leaflet in a preferred embodiment of the present invention. intention
  • Figure 8 is a schematic diagram of a usage scenario after the valve anchor and artificial heart valve are implanted in a preferred embodiment of the present invention.
  • valve anchor 1 elastic wire 11; accommodation part 12; cavity 121; cavity tube 122; accommodation structure 123; through hole 124; traction body 13; inner cavity 14; anchoring section 15; grabbing section 16 ; Native leaflets 21; chordae tendineae 22; artificial heart valve 3; outflow section 31; annulus section 32; flange section 33; delivery sheath 4.
  • orientation or positional relationship is based on the orientation or positional relationship shown in the drawings, which is only for the convenience of describing the present invention and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation or be constructed in a specific orientation. and operation, and therefore cannot be construed as limitations of the present invention.
  • first and second are only used for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of indicated technical features. Therefore, features defined as “first” and “second” may explicitly or implicitly include at least one of these features.
  • “plurality” means at least two, such as two, three, etc., unless otherwise clearly and specifically limited.
  • the terms “installation”, “connection”, “fixing” and other terms should be understood in a broad sense.
  • it can be a fixed connection, a detachable connection, or an integrated connection.
  • It can be a mechanical connection, an electrical connection or communication with each other; it can be a direct connection, or it can be connected through an intermediate medium, it can be an internal connection between two elements or an interactive relationship between two elements, unless otherwise specified limited.
  • it can be based on The specific meanings of the above terms in the present invention will be understood in specific circumstances.
  • proximal end generally refers to the end that is close to the operator; the term “distal end” is opposite to the “proximal end” and generally refers to the end that is far away from the operator.
  • radial refers to the direction parallel to the native annulus after the valve anchor or valve system is implanted in the heart, that is, the radial direction of the native annulus;
  • axial refers to is the direction perpendicular to the native valve annulus after the valve anchor or valve system is implanted in the heart, that is, the axial direction of the native valve annulus.
  • the core idea of the present invention is to provide a valve anchor and a valve system.
  • the artificial heart valve can be firmly anchored to the native valve leaflets in the heart, such as anchored to the aortic valve, tricuspid valve or mitral valve. valve, thus replacing the original heart valve (aortic valve, tricuspid valve or mitral valve).
  • the heart contains four chambers, namely the left atrium, the right ventricle, the right atrium and the left ventricle. Throughout the cardiac cycle, the pumping action of the left and right sides of the heart generally occurs simultaneously.
  • the membrane that separates the atria from the ventricles is called an atrioventricular valve.
  • Each atrium is connected to the corresponding atrial valve through the atrium vestibule.
  • the atrioventricular valve acts as a one-way valve, ensuring the normal flow of blood in the cardiac chambers.
  • the atrioventricular valve between the left atrium and the left ventricle is the mitral valve, and the atrioventricular valve between the right atrium and the right ventricle is the tricuspid valve.
  • the pulmonary valve directs blood flow to the pulmonary artery and to the lungs; blood then flows through the pulmonary veins to the left atrium.
  • the aortic valve guides blood flow through the aorta and throughout the body.
  • the aortic and pulmonic valves close to prevent blood in the arteries from flowing back into the ventricles; at the same time, the mitral and tricuspid valves open to allow blood to flow from the atria into the corresponding ventricles.
  • the mitral and tricuspid valves close to prevent blood from entering the corresponding ventricles from the atria; at the same time, the aortic and pulmonic valves open to allow blood to be pumped from the ventricles and through the aorta and pulmonary arteries Reach the whole body and lungs; then the left atrium and right atrium relax, allowing peripheral blood to return to the left atrium and right atrium.
  • the atrioventricular valve usually includes the annulus, native leaflets, chordae tendineae and supporting structures. Among them, the mitral valve has two native valve leaflets, and the tricuspid valve has three native valve leaflets. The contact between the native valve leaflets can close or seal the mitral valve or tricuspid valve, thereby preventing Blood circulates between the ventricles and atria. Insufficient sealing between the native leaflets of the mitral and tricuspid valves is called heart valve insufficiency or malcoaptation.
  • Atrioventricular valve insufficiency may also cause blood to flow back from the left atrium to the pulmonary veins, causing pulmonary disease. Congestion; severe atrioventricular valve regurgitation, which can lead to permanent disability or death if left untreated.
  • the valve anchor needs to rely on the rope sheath structure to make the guide wire form a guide coil when it is released, and when the anchor ring is released along the guide coil, it also needs to be in the anchor ring.
  • the fastening device is designed at the end so that the anchoring ring forms a closed ring structure, which will complicate the delivery process of the anchoring ring delivery system and increase the difficulty of implanting the valve anchor.
  • the present invention provides a valve anchor that does not require a rope structure to capture the guide wire, which can simplify the implantation process of the valve anchor and reduce the difficulty of implanting the valve anchor, thereby enabling Improve the reliability and convenience of artificial heart valve surgery.
  • the first preferred embodiment of the present invention provides a valve anchor 1 (hereinafter referred to as the valve anchor 1).
  • the valve anchor 1 includes an elastic wire 11, an accommodating portion 12 and a traction body 13 ;
  • the accommodating portion 12 is arranged outside the elastic yarn 11 and connected to the elastic yarn 11;
  • the accommodating portion 12 is distributed along the entire extension direction of the elastic yarn 11 and has a cavity 121, so that the shape of the accommodating portion 12 corresponds to the elastic yarn 11;
  • the traction body 13 is partially disposed in the cavity 121 of the accommodating part 12, and the traction body 13 is divided into two parts after being wound into a closed loop at the end of the accommodating part 12 corresponding to the distal end of the elastic wire 11.
  • the distal end of the accommodating part 12 forms a closed loop and serves as a force application point; in addition, the two parts of the traction body 13 extend along the axis of the accommodating part 12 in the accommodating part 12, and the two ends of the traction body 13
  • the accommodating portion 12 extends from the end portion of the accommodating portion 12 corresponding to the proximal end of the elastic wire 11 to facilitate the operator to operate the traction body 13 .
  • the valve anchor 1 has a contracted state and an expanded state and is capable of switching between the contracted state and the expanded state.
  • the traction body 13 can be pulled to control the movement direction of the distal end of the valve anchor 1 .
  • the traction body 13 is wound into a closed loop at the end of the accommodating portion 12 corresponding to the distal end of the elastic wire 11 , which means that the traction body 13 can bypass the distal end of the valve anchor 1 and be divided into two parts, and then the traction body 13 can be wound into a closed loop.
  • the two parts of 13 can be extended in the cavity 121. At this time, the two parts of the traction body 13 can be pulled And the movement direction of the distal end of the valve anchor 1 is controlled.
  • the traction body 13 is movably disposed in the cavity 121 of the accommodating part 12, and either end of the traction body 13 can be pulled to move the distal end of the entire valve anchor 1 in a predetermined direction.
  • the distal end of the valve anchor 1 is returned to its original pre-shaped position, thereby restoring the entire valve anchor 1 to its pre-shaped shape.
  • the distal end of the entire valve anchor 1 can always move along the cavity wall of the predetermined chamber, and the valve anchor 1 can be gathered and shaped according to the shape of the cavity wall.
  • the valve anchor 1 can be positioned around the native valve leaflets of the intended subject, and the valve anchor 1 can be fixed at the native valve annulus using the artificial heart valve 3 .
  • the valve anchor 1 has a spiral shape in the expanded state and has an annular inner cavity 14 for accommodating the artificial heart valve 3 .
  • FIG 8 shows an application scenario of the artificial heart valve 3 according to a specific embodiment of the present invention.
  • the artificial heart valve 3 is partially accommodated in the annular inner cavity 14, and the valve anchor 1 is positioned and fixed through the expansion or structure of the artificial heart valve 3 At the mitral annulus.
  • the fixation method of the valve anchor 1 is related to the structure of the artificial heart valve 3 .
  • the artificial heart valve 3 can adopt an existing structure. Specifically, it can include an interconnected outflow section 31 and an annulus section 32.
  • the artificial heart valve also includes a flange section 33 to improve the performance of the artificial heart valve 3. anchoring effect and prevent the occurrence of paravalvular leakage.
  • the outflow section 31 , annulus section 32 and flange section 33 are connected axially in sequence, and after the artificial heart valve 3 is expanded, the inner diameters of the outflow section 31 and the flange section 33 are both larger than the inner diameter of the annulus section 32 .
  • the artificial heart valve 3 has the above-mentioned structure of convex at both ends and concave in the middle (i.e., waist-shaped structure)
  • the artificial heart valve 3 can expand without compressing the valve anchor 1.
  • the valve anchor 1 is close to the artificial heart valve.
  • the valve annulus section 32 is positioned at the valve annulus section 32 and can be stuck in the depression through the outflow section 31 and the flange section 33 of the artificial heart valve 3 .
  • the valve anchor 1 can be pressed against the annulus through expansion of the artificial heart valve 3. At this time, the valve anchor 1 can adapt to the expanded shape when deformed by force.
  • the outer contour of the artificial heart valve 3 is used to exert anchoring force on the artificial heart valve 3 .
  • the valve anchor 1 may be placed in the delivery sheath 4 and moved to the mitral annulus with the delivery sheath 4 , and then the valve anchor 1 is delivered Tie
  • the delivery sheath 4 can be gradually removed under the push of the system and released in the left ventricle.
  • the valve anchor 1 adjusts the moving direction of the distal end of the valve anchor 1 by pulling the traction body 13, thereby ensuring the valve anchoring.
  • the distal end of the component 1 always moves in a predetermined direction, and is finally spirally wound in a predetermined direction under the control of the traction body 13 and surrounds the native valve leaflet 21 .
  • the traction body 13 controls the orientation of the distal end of the valve anchor 1, so that the valve anchor 1 can move without being disturbed by the periodic movement of the heart and always be parallel to the native valve annulus, thereby ensuring After the valve anchor 1 is fully expanded, it can grasp all the native valve leaflets 21 and chordae tendineae 22 and other native tissues to avoid being affected by the anatomical structure of the heart from sliding toward the apex or stabbing the myocardium, thereby improving the efficiency of the artificial heart valve 3 surgery. Reliability and security.
  • the predetermined object refers to the subject who needs to be implanted with the artificial heart valve 3, and the predetermined object generally refers to the human heart.
  • the predetermined chamber refers to a chamber in the heart that can accommodate and fix the valve anchor 1.
  • the predetermined chamber refers to the left ventricle or the right ventricle of the human body.
  • the predetermined direction refers to the movement direction of the distal end of the valve anchor 1 that enables the valve anchor 1 to surround the native valve leaflet 21 and does not point toward the apex or damage the myocardial wall.
  • the predetermined direction is along the predetermined cavity. The direction of the chamber walls.
  • An embodiment of the present invention also provides a valve system, which includes an artificial heart valve 3 and a valve anchor 1 .
  • the artificial heart valve 3 is used to be accommodated in the valve anchor 1 .
  • This valve system does not require a rope structure to capture the guide wire.
  • the valve anchor 1 is in a spiral shape, there is no need to design a docking fastening device on the valve anchor 1. This can simplify the implantation process of the valve anchor 1 and reduce the cost of the valve.
  • the difficulty of implanting the anchor 1 can also improve the success rate of implanting the artificial heart valve 3, thereby reducing harm to the patient.
  • the outer diameter of the artificial heart valve 3 is larger than the inner diameter of the valve anchor 1, so that after the artificial heart valve 3 is implanted, the valve anchor 1 can be deformed by force after the artificial heart valve 3 expands, because the elastic wire 11 With elasticity, the valve anchor 1 can also adapt to the external contour of the artificial heart valve 3 when deformed by force, and can exert an anchoring force on the artificial heart valve 3 through the interference fit between the valve anchor 1 and the artificial heart valve 3 , so that the artificial heart valve 3 can be more firmly connected to the valve anchor 1, and the valve anchor 1 can also be used to provide the anchoring force for the artificial heart valve 3 to be anchored in the heart, so as to realize the anchoring force of the artificial heart valve 3 in the native valve.
  • the fixation at the leaflet 21 means that the artificial heart valve 3 is fixed in a predetermined object through the valve anchor 1 .
  • the elastic wire 11 is made of elastic material.
  • the elastic material is preferably a material with a shape memory function and a strong elastic deformation ability to ensure that the elastic wire 11 can perform larger deformation in the axial, radial or circumferential direction. degree of elastic deformation.
  • the elastic yarn 11 can be shaped into a spiral shape in advance, so that the elastic yarn 11 can be stretched along the extension direction (ie, the length direction) and placed in the delivery sheath 4 . When the valve anchor 1 is released, the elastic wire 11 can return to the spiral shape while gradually moving out of the delivery sheath 4 , so that the valve anchor 1 can form a spiral shape after expansion and be anchored at the position of the native valve leaflet 21 .
  • the elastic wire 11 can be configured to be one or a combination of stainless steel, titanium alloy, and nickel-titanium alloy.
  • the material of the elastic wire 11 can also be configured to be a polymer material, such as nylon material, polyester fiber, etc.
  • each elastic thread 11 can be made of one or more combinations of materials, for example, different types of material segments can be connected to each other to form the elastic thread 11 .
  • the elastic wire 11 can be a solid or hollow structure, as long as it can provide strong enough support.
  • the cross-sectional shape of the elastic yarn 11 is not limited, such as circular, annular or rectangular, or it can also be designed with variable diameter or variable cross-section, that is, the cross-sectional size or shape of the elastic yarn 11 at different positions is different.
  • valve anchor 1 the cross-sectional shape of the elastic yarn 11 is not limited, such as circular, annular or rectangular, or it can also be designed with variable diameter or variable cross-section, that is, the cross-sectional size or shape of the elastic yarn 11 at different positions is different.
  • the traction body 13 does not limit the material used to prepare the traction body 13.
  • the traction body 13 only needs to be able to be stretched and bent.
  • the traction body 13 in this application can be configured as a metal wire, a metal tube or a polymer wire, etc.
  • the traction body 13 can be configured as one or more combinations of stainless steel wire, titanium alloy wire, and nickel-titanium alloy wire.
  • the diameter of the traction body 13 can be set to 0.1 mm to 1.5 mm to facilitate the movement of the traction body 13 in the cavity 121 of the accommodating part 12. .
  • the accommodating part 12 is provided with a plurality of independently arranged cavities 121 (see Figure 1) for the traction body 13 to pass through.
  • the end corresponding to the distal end of the elastic wire 11 is bent and then penetrated into another cavity 121 .
  • each cavity 121 is a continuous cavity, and the traction body 13 can penetrate into the proximal end of a cavity 121 of the accommodating part 12 and draw from the far end of the cavity 121 .
  • the traction body 13 then passes through the distal end of the other cavity 121 after bending the end of the accommodating portion 12 corresponding to the distal end of the elastic wire 11, and passes through the distal end of the elastic wire 11 from the other end.
  • the proximal end of one of the cavities 121 exits. It should be noted that the proximal end of the cavity 121 corresponds to the proximal end of the elastic wire 11, so that the proximal end of the accommodating portion 12 is close to the proximal end of the elastic wire 11; the distal end of the cavity 121 corresponds to the distal end of the elastic wire 11, so that The distal end of the accommodating portion 12 is close to the distal end of the elastic wire 11 .
  • valve anchor 1 begins to release (as shown in Figure 5) and the distal end of the valve anchor 1 moves away from the predetermined direction and slides toward the apex (as shown in Figure 6), the operator can pull both ends of the traction body 13 , so that the distal end of the valve anchor 1 is bent toward the proximal end, so that the entire valve anchor 1 returns to its predetermined spiral shape and continues to move along the wall direction of the predetermined chamber (as shown in Figure 7), so that it can be During the release process of the valve anchor 1, the moving direction of the distal end of the valve anchor 1 is controlled multiple times until the valve anchor 1 surrounds the native valve leaflet 21.
  • the traction body 13 can be pulled away so that the valve anchor 1 is fixed at the position of the native valve annulus, thereby completing the implantation of the valve anchor 1 .
  • the elastic wire 11 in the valve anchor 1 has a shape memory function, the valve anchor 1 can automatically return to its predetermined spiral shape after expansion.
  • pulling both ends of the traction body 12 can bend the distal end of the valve anchor 1, so that the valve anchor 1 can continue to move along the wall direction of the predetermined chamber.
  • the number of the traction bodies 13 is one, and the accommodating part 12 includes two hollow tubes 122 arranged side by side, and the two hollow tubes 122 are both connected to the elastic wire 11 Arranged in parallel, each hollow tube 122 has a cavity 121, so that two parts of one traction body 13 are respectively inserted into the two hollow tubes 122.
  • two hollow tubes 122 can be connected to the elastic wire 11 respectively.
  • the two hollow tubes 122 can be disposed on both sides of the elastic wire 11 .
  • two hollow tubes 122 are connected to each other, and only one hollow tube 122 is connected to the elastic wire 11.
  • the elastic wire 11 and one hollow tube 122 can be arranged in another cavity.
  • each cavity tube 122 is connected to the elastic wire 11 and another cavity tube 122 respectively, that is, the elastic wire 11 and the two cavity tubes 122 form a triangle-like structure ( Referring to the structure of the elastic wire 11 and the cavity tube 122 in Figure 1), the cross-sectional size of the valve anchor 1 can be reduced to facilitate the delivery of the delivery system.
  • the delivery system refers to the delivery system of the valve anchor 1 or the artificial heart valve 3, that is, it refers to a device that can carry the compressed valve anchor 1 or the artificial heart valve 3 to move within a predetermined object (such as the human heart) .
  • the hollow tube 122 can be made of a lower strength Made of polymer materials, such as polyethylene, PU or polytetrafluoroethylene.
  • the lengths of the elastic wire 11 and the cavity tube 122 are the same.
  • the elastic wire 11 and the cavity tube 122 are positioned correspondingly and can be connected by sewing, bonding or other methods at the contact positions. .
  • the accommodating part 12 may also include only one hollow tube 122.
  • the hollow tube 122 is provided with a cavity 121 for the traction body 13 to pass through.
  • the traction body 13 is in After the distal end of the valve anchor 1 forms a closed loop (for example, after the traction body 13 passes through the two circular holes at the distal end of the valve anchor 1), it enters the cavity 121 of the cavity tube 122.
  • the number of the traction bodies 13 is two, and the accommodating part 12 includes four hollow tubes 122 sequentially distributed along the elastic wire 11 , and the four hollow tubes 122 are all connected with each other.
  • the elastic wires 11 are arranged in parallel, and each cavity tube 122 has a cavity 121, so that two parts of each traction body 13 are respectively inserted into the corresponding two cavity tubes 122.
  • four hollow tubes 122 can be connected to each other to form a square-like structure and then connected to the elastic wire 11 . At this time, only two hollow tubes 122 are connected to the elastic wire 11 .
  • the four hollow tubes 122 can be connected to the elastic wire 11 and an adjacent hollow tube 122.
  • the four hollow tubes 122 can be connected to each other to form a square-like structure, and then the elastic wires can be connected to each other. 11 is inserted into the square structure (refer to the structure of the elastic wire 11 and the cavity tube 122 in Figure 3). Therefore, this application does not limit the placement positions of the elastic wire 11 and the elastic tube 15 .
  • the material, size and stiffness of each hollow tube 122 may be the same or different. Preferably, they are the same to facilitate the traction body 13 to better control the distal end of the hollow tube 122 .
  • the two parts of each traction body 13 can be wrapped around the end of the accommodation portion 12 corresponding to the distal end of the elastic wire 11 .
  • a closed loop is made and passes through different cavities 121 .
  • two traction bodies 13 can be cross-arranged at the distal end of the valve anchor 1 (refer to Figure 3). At this time, the two parts of each traction body 13 wound into a closed loop can pass through the elastic edges respectively.
  • the wire 11 is axially symmetrically arranged in the cavities 121 of the two cavity tubes 122 .
  • the operator can fix a traction body 13 and pull Two ends of another traction body 13, and pulling different traction bodies 13 can make the distal end of the valve anchor 1 move toward
  • the traction body 13 can control the distal movement of the valve anchor 1 in a more directional manner. Specifically, pulling different traction bodies 13 can make the distal end of the valve anchor 1 move in a predetermined direction away from the atrium or in a predetermined direction close to the atrium, so that the distal end of the valve anchor 1 can move to the predetermined position more accurately. position, and the distal end of the valve anchor 1 continues to move along the wall of the predetermined chamber.
  • two pulling bodies 13 can be arranged in parallel at the distal end of the valve anchor 1.
  • the two parts of each pulling body 13 wound into a closed loop can pass through the adjacent cavity tubes respectively.
  • 122 in the cavity 121 at this time the operator can fix one of the traction bodies 13 and pull both ends of the other traction body 13, so that the distal end of the valve anchor 1 can be moved to the predetermined position. And the distal end of the valve anchor 1 continues to move along the cavity wall of the predetermined cavity.
  • the distal end of the accommodating part 12 is sealed, which can facilitate the movement of the traction body 13 in the cavity 121, and can reduce the resistance of the traction body 13 entering or withdrawing from the delivery system, and can also reduce Risk of thrombosis distal to valve anchor 1.
  • all the distal ends of the cavity tubes 122 are in contact with the predetermined chamber.
  • a silicone gasket can be placed at the distal end of the cavity 121 to prevent the distal end of the valve anchor 1 . End seal.
  • the distal end of the accommodating portion 12 is closed and has a spherical, conical or elliptical shape.
  • Such an arrangement can on the one hand reduce the risk of thrombosis caused by the implantation of the valve anchor 1; on the other hand, it can The distal end of the valve anchor 1 can be smoothly transitioned to prevent the distal end of the valve anchor 1 from scratching the myocardial wall or the cardiac apex.
  • the accommodating portion 12 includes a plurality of accommodating structures 123 spaced apart along the extension direction of the elastic wire 11 , and each accommodating structure 123 has a plurality of accommodating structures 123 arranged side by side along the radial direction of the elastic wire 11 .
  • each receiving structure 123 includes two circular rings that are connected to each other and are both connected to the elastic wire 11.
  • Each of the circular rings has a through hole 124, and the traction body 13 passes through all of the circular rings in sequence.
  • the corresponding row of through holes 124 in the ring is bent and then penetrated into the corresponding another row of through holes in all the rings after being bent corresponding to the distal end of the elastic wire 11. 124, thereby reducing the risk of thrombosis that may be caused by the hollow tube 122.
  • the two rings of each containing structure 123 can also be separated and connected to the elastic wire 11 respectively.
  • the accommodation structure 123 is not limited to a ring.
  • the accommodation structure 123 only needs to include two through holes 124 arranged side by side. This application does not limit the specific structure of the accommodation structure 123 .
  • This application does not limit the number of accommodation structures 123, and the number of accommodation structures 123 can be set as needed.
  • the distance between the receiving structures 123 at the distal position of the valve anchor 1 can be reduced, or the receiving structure at the distal position of the valve anchor 1 can be increased.
  • 123mm wall thickness This application does not limit the connection method between the accommodation structure 123 and the elastic thread 11.
  • the accommodation structure 123 can be connected to the elastic thread 11 by welding, sewing or gluing.
  • the valve anchor 1 has an anchoring section 15 for surrounding the native valve leaflet 21.
  • the anchoring section 15 has at least 1 turn of coil, and the number of turns here is the predetermined number of turns of the anchoring section 15. The number of winding turns when forming. It is preferably 2 turns, so that the anchoring section 15 can have sufficient anchoring force for the artificial heart valve 3, and can deform when the artificial heart valve 3 expands and adapt to the external contour of the artificial heart valve 3, so that it can be anchored by the valve. Part 1 realizes the anchoring of the artificial heart valve 3.
  • the inner diameter of the anchoring segment 15 (ie, the maximum diameter of the lumen 14 in the valve anchor 1) generally corresponds to the size of the native valve leaflet 21, as in this embodiment, the anchor
  • the radius of the inner contour of the segment 15 is 5 mm to 20 mm, and a suitable valve anchor 1 can be selected according to different patients.
  • This application does not limit the shape of the anchoring segment 15.
  • the expanded outer contour shape of the anchoring segment 15 corresponds to the inner contour shape of the native valve leaflet 21 to achieve better anchoring.
  • the expanded shape of the anchoring segment 15 can be Be circular, arc or elliptical, etc.
  • the anchoring segment 15 may be wound by an elastic wire 11 of one material and a hollow tube 122 of one material.
  • the anchoring section 15 can also be formed by connecting elastic wires 11 of two or more materials and hollow tubes 122 of more than two materials in sections.
  • the elastic wires 11 of different types of materials can be connected to each other. Connect, connect the cavity tubes 122 of different types of materials to each other, and then connect the elastic wire 11 and the cavity tube 122 in the radial direction to form the anchoring section 15 .
  • a covering layer with a high friction coefficient can be coated on the surface of the anchoring section 15.
  • the high friction coefficient covering layer may be one or a combination of polyethylene and PET materials.
  • the valve anchor 1 in the expanded state, preferably also has a grabbing section 16 axially connected to the anchoring section 15, and the radius of curvature of the grabbing section 16 is greater than the radius of curvature of the anchoring section 15. , so that the valve anchor 1 moves along the cavity wall of the predetermined cavity and expands and forms when implanted.
  • the grabbing section 16 can always be close to the wall of the predetermined chamber, so that the valve anchor 1 can grab all
  • the native valve leaflets 21 and chordae tendineae 22 and other native tissues will be accommodated in the inner cavity 14 (that is, surrounding all the native valve leaflets 21 and tendineae) when the valve anchor 1 moves. Chordae tendineae 22) to ensure that the artificial heart valve 3 can closely adhere to the native valve leaflets 21 after implantation.
  • the artificial heart valve 3 cannot adhere closely to part of the native valve leaflets 21 after implantation, which may cause paravalvular leakage and may lead to the failure of the artificial heart valve 3 operation.
  • the curvature radius of each part of the anchoring section 15 can be increased, so as to The anchoring segment 15 can move along the wall of the predetermined chamber by itself after being released.
  • the traction body 13 is withdrawn, and the anchoring segment 15 can automatically return to the predetermined coil structure with a smaller radius of curvature and closely adhere to the native valve leaflet 21.
  • the valve anchor 1 can automatically Adapt to the external contour of the artificial heart valve 3 and provide anchoring force to the artificial heart valve 3 .
  • the valve anchor 1 can reduce the initial radius of curvature of the grasping section 16, or make the radius of curvature of the grasping section 16 the same as the radius of curvature of the anchoring section 15. At this time, after the valve anchor 1 is implanted, the grasping section 16 can The segment 16 will not be suspended inside the predetermined chamber, thereby facilitating long-term implantation of the valve anchor 1 in the human body.
  • the radius of curvature of the grasping section 16 usually corresponds to the size of the predetermined cavity, that is, the radius of the expanded outer contour of the grasping section 16 is consistent with the predetermined size.
  • the radius of the inner contour of the chamber corresponds, and the valve anchor 1 can be selected according to different patients, so that the valve anchor 1 can move closely against the wall of the predetermined chamber without being easily inserted. within the myocardial wall.
  • the grabbing section 16 can be an arc structure or a coil structure.
  • the grabbing section 16 can be composed of a single arc, or can be connected by multiple arcs, and the length of the arc can be set as needed.
  • the curvature radius of each arc segment in the multiple arcs that make up the grasping section 16 is 10 mm to 30 mm, so as to better assist the valve anchor 1 in grasping all the native valve leaflets 21, chordae tendineae 22 and other structures.
  • the grabbing section 16 is a coil structure, the number of turns of the coil structure does not exceed 2, so that the grabbing section 16 can be easily deformed and change the moving direction under the pulling of the traction body 13 .
  • a covering layer with a low friction coefficient can be coated on the surface of the grabbing section 16 .
  • the low friction coefficient covering layer may be one or a combination of polytetrafluoroethylene or velvet cloth.
  • different elastic wires 11 and hollow tubes 122 can be used to make the anchoring section 15 and the grabbing section 16 respectively, and the anchoring section 15 and the grabbing section 16 can be connected to each other to form the valve anchor 1, that is, , the anchoring section 15 and the grabbing section 16 are made separately and then connected to each other.
  • an elastic wire 11 and a cavity tube 122 connected to each other can also be wound successively to form the anchoring section 15 and the grabbing section 16 to form the integrated valve anchor 1 .
  • the implantation process of the valve anchor 1 and the artificial heart valve 3 is:
  • the valve anchor 1 is contracted in the delivery sheath 4.
  • the delivery sheath 4 can enter the left ventricle via the aorta, atrium or other paths, and then the valve anchor 1 can be pushed to the left ventricle.
  • the sheath port of sheath 4 is delivered and release of valve anchor 1 is initiated in the left ventricle.
  • the grasping section 16 of the valve anchor 1 is pushed out from the delivery sheath 4. Since the pre-shaped grasping section 16 of the valve anchor 1 has a large curvature radius, when the grasping section 16 moves in the ventricle, Can advance along the cavity wall.
  • valve anchor 1 when the valve anchor 1 is disturbed by the movement of the ventricular wall or the distal end of the valve anchor 1 enters the longitudinal gap of the myocardium, the distal end of the valve anchor 1 may slide toward the apex of the heart and stop at this time.
  • the distal end of the valve anchor 1 By advancing the valve anchor 1 and pulling both ends of the traction body 13, the distal end of the valve anchor 1 is separated from the myocardial wall and returned to the predetermined position, and the distal end of the valve anchor 1 is reconnected with the native valve annulus. parallel, so that the distal end of the valve anchor 1 can continue to move along the wall of the predetermined chamber. Then continue to advance the valve anchor 1.
  • valve anchor 1 During the release process of the valve anchor 1, if the valve anchor 1 The distal end moves toward the apex again, and the traction body 13 can be pulled again to adjust the moving direction of the distal end of the valve anchor 1. This operation is repeated until the valve anchor 1 can surround all the native valve leaflets 21 and chordae tendineae 22 and other native valves. organize. When it is confirmed that the valve anchor 1 has completely separated from the delivery sheath 4 and can surround the native valve leaflets 21 , the delivery system is allowed to maintain the position of the valve anchor 1 and the implantation of the artificial heart valve 3 begins.
  • the artificial heart valve is used to replace and replace the natural mitral valve.
  • the artificial heart valve 3 can enter the atrium via the inferior vena cava or other pathways, and cross the native valve leaflets 21 into the inner cavity 14 of the valve anchor 1; the artificial heart valve 3 can be expanded by a balloon or by a self-contained valve.
  • the diameter of the anchoring segment 15 in the valve anchor 1 will be elastically deformed or plastically deformed during the diameter expansion, and the anchoring segment 15 can adapt to the annular segment of the artificial heart valve 3 when deformed. 32, and is fully fixedly connected and sealed with the valve annulus segment 32, so that the valve anchor 1 and the artificial heart valve 3 are fixedly connected as a whole.
  • the anchoring section 15 can exert an anchoring force on the expanded artificial heart valve 3 to achieve anchoring of the artificial heart valve 3 at the position of the native valve leaflets 21 .
  • the artificial heart valve 3 includes an outflow section 31, an annulus section 32 and a flange section 33 that are connected in sequence in the axial direction. After the artificial heart valve 3 is expanded, The inner diameters of the outflow section 31 and the flange section 33 are both larger than the inner diameter of the annulus section 32 . After the valve anchor 1 and the artificial heart valve 3 are implanted, the implantation positions of the valve anchor 1 and the artificial heart valve 3 need to be adjusted so that the valve anchor 1 is located at the annular segment 32 of the artificial heart valve 3, and The valve anchor 1 is made to surround and abut against the native valve leaflets 21.
  • the expanded artificial heart valve 3 can provide the valve anchor 1 with anchoring force within a predetermined object.
  • the outflow section 31 and the flange section 33 with a larger radius can limit the annular section 32 of the artificial heart valve 3 in the axial direction, that is, the annular section 32 can only be located at the position of the valve anchor 1. This ensures that the artificial heart valve 3 cannot move in the axial direction after implantation.
  • the operator can extract the traction body 13 and withdraw the delivery system after confirming that the artificial heart valve 3 and the valve anchor 1 have been firmly implanted in the predetermined position, thereby completing the artificial heart valve 3 and the valve anchor. 1 implant surgery.
  • valve system provided by the embodiments of the present invention may include the valve anchor 1 provided in any embodiment.
  • the valve with the elastic wire 11 can be gradually expanded and surround the native valve leaflets after expansion.
  • the valve anchor 1 can also adjust the movement direction of the distal end of the valve anchor 1 through the traction body 13 during the expansion process, thus ensuring that the valve anchor 1 can Always moving along the wall of the predetermined chamber also allows the valve anchor 1 to move without being disturbed by the periodic movement of the heart and always parallel to the native valve annulus, thereby ensuring that the valve anchor 1 can grasp after full expansion.
  • All native valve leaflets 21 and chordae tendineae 22 and other native tissues can avoid being affected by the anatomical structure of the heart from sliding toward the apex or puncturing the myocardium, thereby improving the reliability and safety of the artificial heart valve 3 surgery.
  • the valve system does not require a rope structure to capture the guide wire, which can simplify the implantation process of the valve anchor 1, reduce the difficulty of implanting the valve anchor 1, and also improve the success rate of artificial heart valve 3 implantation, thus It can reduce harm to patients and facilitate their postoperative recovery.
  • the valve anchor 1 provided by the present invention includes an anchoring section 15.
  • the anchoring section 15 can realize the connection between the artificial heart valve 3 and the anchoring section 15 through the interference fit between the inner cavity 14 and the artificial heart valve 3.
  • the applied anchoring force of heart valve 3. After the valve anchor 1 is implanted, the traction body 13 is withdrawn, and the valve anchor 1 can adapt to the external contour of the artificial heart valve 3, so that the artificial heart valve 3 can be fixed in a predetermined object through the valve anchor 1.

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

Provided are a valve anchoring member (1) and a valve system. The valve anchoring member (1) comprises an elastic wire (11), an accommodating part (12), and a traction body (13). The accommodating part (12) is arranged outside the elastic wire (11) and is connected to the elastic wire (11). The accommodating part (12) is distributed in an extension direction of the elastic wire (11) and has a cavity. The traction body (13) is partially arranged in the cavity of the accommodating part (12), and is divided into two parts after being wound into a closed loop on the end portion of the accommodating part (12) corresponding to the distal end of the elastic wire (11). The two parts extend along the axis of the accommodating part (12) in the accommodating part (12), and both ends of the traction body (13) extend out of the accommodating part (12) on the end portion of the accommodating part (12) corresponding to the proximal end of the elastic wire (11). The traction body (13) can be pulled to control the direction of movement of the distal end of the valve anchoring member (1). In terms of the valve anchoring member (1), under the cooperation of the elastic wire (11) and the traction body (13), the valve anchoring member can accurately surround native valve leaflets, thereby simplifying the implantation steps of the valve anchoring member and reducing the implantation difficulty.

Description

一种瓣膜锚固件及瓣膜***Valve anchor and valve system 技术领域Technical field
本发明涉及医疗器械技术领域，特别涉及一种瓣膜锚固件及瓣膜***。The present invention relates to the technical field of medical devices, and in particular to a valve anchor and a valve system.
背景技术Background technique
经导管二尖瓣置换手术(简称TMVR)就是采用导管介入的方法，将人工心脏瓣膜在体外压缩到输送***后送达人体二尖瓣瓣环处，并将人工心脏瓣膜释放并固定在二尖瓣瓣环处替换原生瓣叶。与外科手术相比，二尖瓣置换手术无须体外循环辅助装置，创伤小、病人恢复快，术后患者血流动力学指标可以得到明显改善，相对于心尖路径，经股静脉的房间隔路径植入创伤更小，受众更广。Transcatheter mitral valve replacement surgery (TMVR for short) uses a catheter intervention method to compress the artificial heart valve into the delivery system outside the body and then deliver it to the human mitral valve annulus. The artificial heart valve is released and fixed on the mitral valve. The native valve leaflets are replaced at the valve annulus. Compared with surgery, mitral valve replacement surgery does not require extracorporeal circulation auxiliary devices, has less trauma, and the patient recovers quickly. The patient's hemodynamic index can be significantly improved after surgery. Compared with the apical route, the atrial septal route implantation through the femoral vein is more convenient. It is less invasive and has a wider audience.
虽然二尖瓣瓣膜置换技术飞速发展，但是人工心脏瓣膜的锚固方式仍然存在一定的局限性。传统的锚固方式主要是通过设计锚固刺抓取原生瓣叶以实现人工心脏瓣膜的固定，或者通过对人工心脏瓣膜的过尺寸设计来固定人工心脏瓣膜。这两种锚固方式均容易造成原生瓣叶的损伤或原生瓣环组织的压迫，从而对患者的康复产生不利影响。Although mitral valve replacement technology has developed rapidly, the anchoring method of artificial heart valves still has certain limitations. The traditional anchoring method mainly fixes the artificial heart valve by designing anchoring spines to grasp the native valve leaflets, or fixing the artificial heart valve by over-sizing the artificial heart valve. Both anchoring methods can easily cause damage to the native valve leaflets or compression of the native valve annulus tissue, thus adversely affecting the patient's recovery.
现有技术还采用锚固件与人工心脏瓣膜分离的设计，比如人工心脏瓣膜由锚固环和瓣膜主体构成，此种锚固环和瓣膜主体分离的设计可以有效避免对原生瓣环的压迫，且不易损伤原生瓣叶，同时使得输送***各部分的尺寸减小，更有利于输送***在体内的移动。该方式中，锚固环与瓣膜主体是分开输送的。其中锚固环输送***释放锚固环的过程复杂，首先锚固环输送***需要在心室内释放绳套结构来捕捉引导丝的端部，以使引导丝形成引导线圈，然后才能沿着所述引导线圈植入锚固环。同时，锚固环的端部还要特殊设计对接的紧固装置，以使锚固环形成封闭的环结构。此外，当人工心脏瓣膜为腰形结构(即两端凸、中间凹)时，为达到预期的锚固效果，需要多次调整人工心脏瓣膜和锚固环的相互位置，以使锚固环恰好卡进人工心脏瓣膜的凹陷处，如此会增加人工心脏瓣膜植入手术的难度和复杂度，并对操作者的操作熟练度具有较高的要求，同时过长的手术时间也对病人的健康产生不 利影响。The existing technology also adopts a design that separates the anchor from the artificial heart valve. For example, the artificial heart valve is composed of an anchoring ring and a valve body. This design of separating the anchoring ring and the valve body can effectively avoid compression of the native valve annulus and is not easily damaged. The native leaflets also reduce the size of each part of the delivery system, which is more conducive to the movement of the delivery system in the body. In this method, the anchoring ring and the valve body are delivered separately. The process of releasing the anchor ring by the anchor ring delivery system is complicated. First, the anchor ring delivery system needs to release the rope loop structure in the ventricle to capture the end of the guide wire so that the guide wire forms a guide coil, and then it can be implanted along the guide coil. Anchor ring. At the same time, the end of the anchor ring must be specially designed with a docking fastening device so that the anchor ring forms a closed ring structure. In addition, when the artificial heart valve has a waist-shaped structure (that is, convex at both ends and concave in the middle), in order to achieve the expected anchoring effect, the mutual positions of the artificial heart valve and the anchoring ring need to be adjusted multiple times so that the anchoring ring can fit into the artificial heart valve. The recess of the heart valve will increase the difficulty and complexity of the artificial heart valve implantation operation and place high requirements on the operator's proficiency. At the same time, the long operation time will also have adverse effects on the patient's health. beneficial impact.
发明内容Contents of the invention
本发明的目的在于提供一种瓣膜锚固件及瓣膜***，能够在弹性丝和牵引体的配合下，使瓣膜锚固件精准环绕原生瓣叶，从而可简化瓣膜锚固件的植入步骤，降低植入难度。The purpose of the present invention is to provide a valve anchor and a valve system that can accurately surround the native valve leaflets with the cooperation of elastic wires and traction bodies, thereby simplifying the implantation steps of the valve anchor and reducing the cost of implantation. Difficulty.
为实现上述至少一个目的，本发明提供一种瓣膜锚固件，所述瓣膜锚固件具有收缩状态和扩张状态，并能够在所述收缩状态和所述扩张状态之间切换；In order to achieve at least one of the above objects, the present invention provides a valve anchor, which has a contracted state and an expanded state and can be switched between the contracted state and the expanded state;
所述瓣膜锚固件包括弹性丝、容置部和牵引体；所述容置部设置在所述弹性丝的外部并与所述弹性丝连接；所述容置部沿着所述弹性丝的延伸方向分布并具有空腔；The valve anchor includes an elastic wire, an accommodating part and a traction body; the accommodating part is arranged outside the elastic wire and connected to the elastic wire; the accommodating part extends along the elastic wire Directionally distributed and with cavities;
所述牵引体部分地设置于所述容置部的空腔内，并在所述容置部对应于所述弹性丝的远端的端部绕制成闭环后分成两部分，所述两部分在所述容置部内沿着所述容置部的轴线延伸，且所述牵引体的两端在所述容置部在对应于所述弹性丝的近端的端部伸出所述容置部；所述牵引体能够被拉动，以控制所述瓣膜锚固件的远端的移动方向。The traction body is partially disposed in the cavity of the accommodating part, and is divided into two parts after the end of the accommodating part corresponding to the distal end of the elastic wire is wound into a closed loop, and the two parts Extends along the axis of the accommodation part in the accommodation part, and the two ends of the traction body extend out of the accommodation part at the end of the accommodation part corresponding to the proximal end of the elastic wire. part; the traction body can be pulled to control the movement direction of the distal end of the valve anchor.
可选的，所述瓣膜锚固件为螺旋形状，并具有用于容纳人工心脏瓣膜的环形的内腔；所述瓣膜锚固件能够在受力变形时自适应扩张后的所述人工心脏瓣膜的外部轮廓，以对所述人工心脏瓣膜施加锚固力。Optionally, the valve anchor is in a spiral shape and has an annular inner cavity for accommodating an artificial heart valve; the valve anchor can adapt to the outside of the expanded artificial heart valve when deformed by force. Contours to exert anchoring forces on the prosthetic heart valve.
可选的，在所述扩张状态下，所述瓣膜锚固件具有用于环绕原生瓣叶的锚固段，所述锚固段具有至少一匝线圈，所述瓣膜锚固件还具有与所述锚固段轴向连接的抓取段；所述抓取段的曲率半径大于所述锚固段的曲率半径，以使所述瓣膜锚固件植入时沿预定腔室的腔壁移动并扩张成型。Optionally, in the expanded state, the valve anchor has an anchoring section for surrounding the native valve leaflet, the anchoring section has at least one turn of coil, and the valve anchor also has an axis with the anchoring section. To connect the grabbing section; the radius of curvature of the grabbing section is greater than the radius of curvature of the anchoring section, so that when the valve anchor is implanted, it moves along the cavity wall of the predetermined cavity and expands to shape.
可选的，所述容置部内设置有供所述牵引体穿设的独立设置的多个空腔，一根所述牵引体穿过一个所述空腔后在所述容置部对应于所述弹性丝的远端的端部弯曲后穿入另一个所述空腔。Optionally, the accommodating part is provided with a plurality of independently arranged cavities for the traction body to pass through. After one of the traction bodies passes through one of the cavities, the accommodating part corresponds to the corresponding cavity. The distal end of the elastic wire is bent and then penetrates into the other cavity.
可选的，所述牵引体的数量为一根，所述容置部包括两根并排设置的空 腔管，两根所述空腔管均与所述弹性丝平行设置，两根所述空腔管相互连接和/或与所述弹性丝连接，每根所述空腔管具有一个所述空腔，以使一根所述牵引体的两部分分别穿设在两根所述空腔管中。Optionally, the number of the traction bodies is one, and the accommodation part includes two hollow traction bodies arranged side by side. Cavity tubes, two of the cavity tubes are arranged parallel to the elastic wire, the two cavity tubes are connected to each other and/or to the elastic wire, each of the cavity tubes has one of the hollow tubes cavity, so that two parts of one said traction body are respectively inserted into two said hollow tubes.
可选的，所述牵引体的数量为两根，所述容置部包括沿所述弹性丝周向依次分布的四根空腔管，四根所述空腔管均与所述弹性丝平行设置，四根所述空腔管相互连接和/或与所述弹性丝连接，每根所述空腔管具有一个所述空腔，以使每根所述牵引体的两部分分别穿设在对应的两根所述空腔管中。Optionally, the number of the traction bodies is two, and the accommodation part includes four hollow tubes distributed sequentially along the circumferential direction of the elastic wire, and the four hollow tubes are all parallel to the elastic wire. It is arranged that four of the hollow tubes are connected to each other and/or to the elastic wire, and each of the hollow tubes has one of the hollow cavities, so that two parts of each of the traction bodies are respectively threaded through in the corresponding two hollow tubes.
可选的，所述容置部的远端端部密封设置。Optionally, the distal end of the accommodating portion is sealed.
可选的，所述容置部的远端端部的形状为球形、圆锥形或椭圆形。Optionally, the shape of the distal end of the accommodating portion is spherical, conical or elliptical.
可选的，所述容置部包括沿所述弹性丝的延伸方向间隔布置的多个容纳结构，每个所述容纳结构具有沿所述弹性丝的径向并排设置的至少两个通孔，所有所述容纳结构的所述通孔组成至少两个所述空腔，所述牵引体沿所述弹性丝的轴线依次穿过所有所述容纳结构中的一排所述通孔后，在所述容置部对应于所述弹性丝的远端的端部弯曲后又依次穿入所有所述容纳结构中的另一排所述通孔。Optionally, the accommodating portion includes a plurality of accommodating structures spaced apart along the extension direction of the elastic wire, each of the accommodating structures having at least two through holes arranged side by side along the radial direction of the elastic wire, The through holes of all the accommodation structures form at least two cavities. After the traction body passes through a row of through holes in all the accommodation structures along the axis of the elastic wire, The end of the accommodating portion corresponding to the distal end of the elastic wire is bent and then penetrates into another row of through holes in all the accommodating structures.
为实现上述目的，本发明还提供一种瓣膜***，其包括人工心脏瓣膜以及任一项所述的瓣膜锚固件，所述人工心脏瓣膜用于容纳在所述瓣膜锚固件中。To achieve the above object, the present invention also provides a valve system, which includes an artificial heart valve and any one of the valve anchors, and the artificial heart valve is used to be accommodated in the valve anchor.
在本发明提供的瓣膜锚固件及瓣膜***中，所述瓣膜锚固件具有收缩状态和扩张状态，并能够在所述收缩状态和所述扩张状态之间切换；所述瓣膜锚固件包括弹性丝、容置部和牵引体；所述容置部设置在所述弹性丝的外部并与所述弹性丝连接；所述容置部沿着所述弹性丝的延伸方向分布并具有空腔；所述牵引体部分地设置于所述容置部的空腔内，并在所述容置部对应于所述弹性丝的远端的端部绕制成闭环后分成两部分，所述两部分在所述容置部内沿着所述容置部的轴线延伸，且所述牵引体的两端在所述容置部对应于所述弹性丝的近端的端部伸出所述容置部；所述牵引体能够被拉动，以控制所述瓣膜锚固件的远端的移动方向。如此配置时，由于瓣膜锚固件在植入前已被预定型为特定结构，如螺旋结构，故瓣膜锚固件在逐步释放时能够环绕 原生瓣叶扩张成型，尤其所述瓣膜锚固件还能够在扩张过程中通过自身牵引体来控制瓣膜锚固件的远端的移动方向(包括远端的朝向)，可确保瓣膜锚固件的远端能够始终沿预定腔室(如心室)的腔壁移动，还可使瓣膜锚固件能够在移动时不受心脏周期性运动的干扰而始终平行于原生瓣环，从而保证瓣膜锚固件在完全扩张后能够抓取全部的原生瓣叶和腱索等原生组织，避免受心脏解剖结构的影响滑向心尖方向或刺伤心肌，进而可提升人工心脏瓣膜手术的可靠性和安全性。In the valve anchor and valve system provided by the present invention, the valve anchor has a contracted state and an expanded state, and can switch between the contracted state and the expanded state; the valve anchor includes elastic wire, accommodating part and traction body; the accommodating part is arranged outside the elastic wire and connected with the elastic wire; the accommodating part is distributed along the extension direction of the elastic wire and has a cavity; The traction body is partially disposed in the cavity of the accommodating part, and is divided into two parts after the end of the accommodating part corresponding to the distal end of the elastic wire is wound into a closed loop. The inside of the accommodating part extends along the axis of the accommodating part, and the two ends of the traction body extend out of the accommodating part at the end of the accommodating part corresponding to the proximal end of the elastic wire; The traction body can be pulled to control the moving direction of the distal end of the valve anchor. When configured in this way, because the valve anchor has been pre-shaped into a specific structure before implantation, such as a spiral structure, the valve anchor can surround the valve during gradual release. The native valve leaflets are expanded and molded. In particular, the valve anchor can also control the moving direction (including the direction of the distal end) of the distal end of the valve anchor through its own traction body during the expansion process, which can ensure that the distal end of the valve anchor can Always moving along the wall of a predetermined chamber (such as the ventricle) also allows the valve anchor to move without being disturbed by the cyclic movement of the heart and always parallel to the native valve annulus, thereby ensuring that the valve anchor can move after full expansion. Grasp all native valve leaflets, chordae tendineae and other native tissues to avoid being affected by the anatomical structure of the heart from sliding toward the apex or puncturing the myocardium, thereby improving the reliability and safety of artificial heart valve surgery.
此外，所述瓣膜***包括人工心脏瓣膜和瓣膜锚固件，所述人工心脏瓣膜用于容纳在所述瓣膜锚固件中。如此配置时，所述瓣膜***无需绳套结构抓捕引导丝，当瓣膜锚固件为螺旋形状时也无需在瓣膜锚固件上设计对接的紧固装置，如此可简化瓣膜锚固件的植入过程，降低瓣膜锚固件的植入难度，还能够提高人工心脏瓣膜植入的成功率，进而可减少对患者的伤害并有利于患者的术后康复。Additionally, the valve system includes a prosthetic heart valve and a valve anchor for receipt in the valve anchor. When configured in this way, the valve system does not need a rope structure to capture the guide wire, and when the valve anchor is in a spiral shape, there is no need to design a docking fastening device on the valve anchor, which can simplify the implantation process of the valve anchor. Reducing the difficulty of implanting valve anchors can also improve the success rate of artificial heart valve implantation, which in turn can reduce harm to patients and facilitate their postoperative recovery.
所述瓣膜锚固件优选具有锚固段，所述锚固段可通过内腔与人工心脏瓣膜之间的过盈配合来实现人工心脏瓣膜与锚固段的连接，并对人工心脏瓣膜的施加锚固力。在瓣膜锚固件植入后，抽离牵引体，瓣膜锚固件可自适应人工心脏瓣膜的外部轮廓，从而可使人工心脏瓣膜通过瓣膜锚固件固定在预定对象中。The valve anchor preferably has an anchoring section, and the anchoring section can realize the connection between the artificial heart valve and the anchoring section through an interference fit between the inner cavity and the artificial heart valve, and exert an anchoring force on the artificial heart valve. After the valve anchor is implanted, the traction body is withdrawn, and the valve anchor can adapt to the external contour of the artificial heart valve, so that the artificial heart valve can be fixed in a predetermined object through the valve anchor.
附图说明Description of the drawings
图1为本发明一优选实施例中的瓣膜锚固件的结构示意图；Figure 1 is a schematic structural diagram of a valve anchor in a preferred embodiment of the present invention;
图2为本发明另一优选实施例中的瓣膜锚固件的局部结构示意图；Figure 2 is a partial structural schematic diagram of a valve anchor in another preferred embodiment of the present invention;
图3为本发明另一优选实施例中的瓣膜锚固件的结构示意图；Figure 3 is a schematic structural diagram of a valve anchor in another preferred embodiment of the present invention;
图4为本发明另一优选实施例中的瓣膜锚固件的结构示意图；Figure 4 is a schematic structural diagram of a valve anchor in another preferred embodiment of the present invention;
图5为本发明一优选实施例中的瓣膜锚固件释放初期的使用场景示意图；Figure 5 is a schematic diagram of the use scene of the valve anchor in the early stage of release in a preferred embodiment of the present invention;
图6为本发明一优选实施例中的瓣膜锚固件朝心尖方向移动的使用场景示意图；Figure 6 is a schematic diagram of a usage scenario in which the valve anchor moves toward the apex direction in a preferred embodiment of the present invention;
图7为本发明一优选实施例中的瓣膜锚固件环绕原生瓣叶的使用场景示 意图；Figure 7 shows a usage scenario of the valve anchor surrounding the native valve leaflet in a preferred embodiment of the present invention. intention;
图8为本发明一优选实施例中的瓣膜锚固件和人工心脏瓣膜植入后的使用场景示意图。Figure 8 is a schematic diagram of a usage scenario after the valve anchor and artificial heart valve are implanted in a preferred embodiment of the present invention.
图中：瓣膜锚固件1；弹性丝11；容置部12；空腔121；空腔管122；容纳结构123；通孔124；牵引体13；内腔14；锚固段15；抓取段16；原生瓣叶21；腱索22；人工心脏瓣膜3；流出段31；瓣环段32；法兰段33；输送鞘管4。In the figure: valve anchor 1; elastic wire 11; accommodation part 12; cavity 121; cavity tube 122; accommodation structure 123; through hole 124; traction body 13; inner cavity 14; anchoring section 15; grabbing section 16 ; Native leaflets 21; chordae tendineae 22; artificial heart valve 3; outflow section 31; annulus section 32; flange section 33; delivery sheath 4.
具体实施方式Detailed ways
以下结合附图和具体实施例对本发明作进一步详细说明。根据下面说明，本发明的优点和特征将更清楚。需说明的是，附图均采用非常简化的形式且均使用非精准的比例，仅用以方便、明晰地辅助说明本发明实施例的目的。The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. The advantages and features of the present invention will become clearer from the following description. It should be noted that the drawings are in a very simplified form and use imprecise proportions, and are only used to conveniently and clearly assist in explaining the embodiments of the present invention.
术语“中心”、“纵向”、“横向”、“长度”、“宽度”、“厚度”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”、“内”、“外”、“顺时针”、“逆时针”、“轴向”、“径向”、“周向”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本发明和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。The terms "center", "lengthwise", "crosswise", "length", "width", "thickness", "top", "bottom", "front", "back", "left", "right", " Vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and other instructions The orientation or positional relationship is based on the orientation or positional relationship shown in the drawings, which is only for the convenience of describing the present invention and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation or be constructed in a specific orientation. and operation, and therefore cannot be construed as limitations of the present invention.
在本发明的描述中，需要理解的是，术语“第一”、“第二”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”的特征可以明示或者隐含地包括至少一个该特征。本发明的描述中，“多个”的含义是至少两个，例如两个，三个等，除非另有明确具体的限定。In the description of the present invention, it should be understood that the terms "first" and "second" are only used for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of indicated technical features. Therefore, features defined as "first" and "second" may explicitly or implicitly include at least one of these features. In the description of the present invention, "plurality" means at least two, such as two, three, etc., unless otherwise clearly and specifically limited.
在本发明中，除非另有明确的规定和限定，术语“安装”、“连接”、“固定”等术语应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或成一体；可以是机械连接，也可以是电连接或彼此可通讯；可以是直接相连，也可以通过中间媒介相连，可以是两个元件内部的连通或两个元件的相互作用关系，除非另有明确的限定。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。In the present invention, unless otherwise expressly stipulated and limited, the terms "installation", "connection", "fixing" and other terms should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integrated connection. ; It can be a mechanical connection, an electrical connection or communication with each other; it can be a direct connection, or it can be connected through an intermediate medium, it can be an internal connection between two elements or an interactive relationship between two elements, unless otherwise specified limited. For those of ordinary skill in the art, it can be based on The specific meanings of the above terms in the present invention will be understood in specific circumstances.
如在本说明书中所使用的，术语“近端”通常是指靠近术者的一端；术语“远端”与“近端”相对，通常是指远离术者的一端。如在本说明书中所使用的，术语“径向”指的是瓣膜锚固件或瓣膜***植入心脏后平行于原生瓣环的方向，也即原生瓣环的径向；术语“轴向”指的是瓣膜锚固件或瓣膜***植入心脏后垂直于原生瓣环的方向，也即原生瓣环的轴向。As used in this specification, the term "proximal end" generally refers to the end that is close to the operator; the term "distal end" is opposite to the "proximal end" and generally refers to the end that is far away from the operator. As used in this specification, the term "radial" refers to the direction parallel to the native annulus after the valve anchor or valve system is implanted in the heart, that is, the radial direction of the native annulus; the term "axial" refers to is the direction perpendicular to the native valve annulus after the valve anchor or valve system is implanted in the heart, that is, the axial direction of the native valve annulus.
本发明的核心思想是提供一种瓣膜锚固件及瓣膜***，通过瓣膜锚固件可将人工心脏瓣膜牢固地锚固在心脏中的原生瓣叶处，如锚固在主动脉瓣、三尖瓣或二尖瓣处，从而代替原有的心脏瓣膜(主动脉瓣、三尖瓣或二尖瓣)。需理解的是，心脏含有四个腔室，即左心房、右心室、右心房和左心室。在整个心动周期中，心脏的左、右两侧的泵送作用一般同步发生。将心房与心室分开的薄膜被称为房室瓣，各心房通过心房前庭与相应的房瓣膜连接，房室瓣起到单向阀的作用，即保证心腔内血液的正常流动。其中左心房和左心室之间的房室瓣是二尖瓣，右心房与右心室之间的房室瓣是三尖瓣。肺动脉瓣将血流导向肺动脉，并使血液流向肺部；而后血液通过肺静脉流向左心房。主动脉瓣引导血流通过主动脉流向全身。The core idea of the present invention is to provide a valve anchor and a valve system. Through the valve anchor, the artificial heart valve can be firmly anchored to the native valve leaflets in the heart, such as anchored to the aortic valve, tricuspid valve or mitral valve. valve, thus replacing the original heart valve (aortic valve, tricuspid valve or mitral valve). It is important to understand that the heart contains four chambers, namely the left atrium, the right ventricle, the right atrium and the left ventricle. Throughout the cardiac cycle, the pumping action of the left and right sides of the heart generally occurs simultaneously. The membrane that separates the atria from the ventricles is called an atrioventricular valve. Each atrium is connected to the corresponding atrial valve through the atrium vestibule. The atrioventricular valve acts as a one-way valve, ensuring the normal flow of blood in the cardiac chambers. The atrioventricular valve between the left atrium and the left ventricle is the mitral valve, and the atrioventricular valve between the right atrium and the right ventricle is the tricuspid valve. The pulmonary valve directs blood flow to the pulmonary artery and to the lungs; blood then flows through the pulmonary veins to the left atrium. The aortic valve guides blood flow through the aorta and throughout the body.
在心室充盈(舒张)期，主动脉瓣和肺动脉瓣关闭，以防止动脉中的血液倒流回心室；同时二尖瓣和三尖瓣打开，以使血液从心房进入相应的心室。在心室收缩(排空)期，二尖瓣和三尖瓣关闭，以防止血液从心房进入相应的心室；同时主动脉瓣和肺动脉瓣打开，以使血液从心室泵出并通过主动脉和肺动脉到达全身和肺部；而后左心房和右心房舒张，以使外周血液回流至左心房和右心房。During the ventricular filling (diastole) phase, the aortic and pulmonic valves close to prevent blood in the arteries from flowing back into the ventricles; at the same time, the mitral and tricuspid valves open to allow blood to flow from the atria into the corresponding ventricles. During the ventricular systole (emptying) phase, the mitral and tricuspid valves close to prevent blood from entering the corresponding ventricles from the atria; at the same time, the aortic and pulmonic valves open to allow blood to be pumped from the ventricles and through the aorta and pulmonary arteries Reach the whole body and lungs; then the left atrium and right atrium relax, allowing peripheral blood to return to the left atrium and right atrium.
当房室瓣出现问题时，常导致房室瓣不能正常进行关闭。房室瓣通常包括瓣环、原生瓣叶、腱索和支持结构。其中，二尖瓣具有两个原生瓣叶，三尖瓣具有三个原生瓣叶，各原生瓣叶之间的抵接能够使二尖瓣或三尖瓣关闭或密封，从而在心室收缩期防止血液在心室和心房之间流通。二尖瓣和三尖瓣的原生瓣叶之间不能完全密封被称为心脏瓣膜关闭不全或接合不良，此时在心室收缩期，心室内的血液可通过二尖瓣或三尖瓣之间的缝隙流回相应的 心房，这往往会导致患者的心脏衰竭、血流量减少、血压降低并减少血液到达人体各组织的氧含量，并且房室瓣关闭不全还可能引起血液从左心房流回肺静脉，从而造成肺部的充血；严重的房室瓣关闭不全，如果不进行治疗可导致患者的永久性残疾或死亡。When there is a problem with the atrioventricular valve, it often causes the atrioventricular valve to fail to close properly. The atrioventricular valve usually includes the annulus, native leaflets, chordae tendineae and supporting structures. Among them, the mitral valve has two native valve leaflets, and the tricuspid valve has three native valve leaflets. The contact between the native valve leaflets can close or seal the mitral valve or tricuspid valve, thereby preventing Blood circulates between the ventricles and atria. Insufficient sealing between the native leaflets of the mitral and tricuspid valves is called heart valve insufficiency or malcoaptation. During ventricular systole, blood in the ventricles can pass through the gap between the mitral or tricuspid valves. gap flows back to the corresponding Atria, which often leads to heart failure, reduced blood flow, lowered blood pressure, and reduced oxygen content in the blood reaching various tissues of the body. Atrioventricular valve insufficiency may also cause blood to flow back from the left atrium to the pulmonary veins, causing pulmonary disease. Congestion; severe atrioventricular valve regurgitation, which can lead to permanent disability or death if left untreated.
如背景技术，传统的瓣膜锚固件与人工心脏瓣膜分离的设计中，瓣膜锚固件在释放时需要依靠绳套结构使引导丝形成引导线圈，且在锚固环沿引导线圈释放时还需要在锚固环的端部设计紧固装置以使锚固环形成封闭环结构，这会导致锚固环输送***的输送过程复杂，还会增加瓣膜锚固件的植入难度。As in the background art, in the traditional design of separating the valve anchor from the artificial heart valve, the valve anchor needs to rely on the rope sheath structure to make the guide wire form a guide coil when it is released, and when the anchor ring is released along the guide coil, it also needs to be in the anchor ring. The fastening device is designed at the end so that the anchoring ring forms a closed ring structure, which will complicate the delivery process of the anchoring ring delivery system and increase the difficulty of implanting the valve anchor.
为了解决以上技术问题，本发明提供一种瓣膜锚固件，该瓣膜锚固件无需绳套结构抓捕引导丝，如此可简化瓣膜锚固件的植入过程，降低瓣膜锚固件的植入难度，进而可提升人工心脏瓣膜手术的可靠性和便利性。In order to solve the above technical problems, the present invention provides a valve anchor that does not require a rope structure to capture the guide wire, which can simplify the implantation process of the valve anchor and reduce the difficulty of implanting the valve anchor, thereby enabling Improve the reliability and convenience of artificial heart valve surgery.
以下结合附图和优选实施例对本发明作详细的说明。在不冲突的情况下，下述的实施方式及实施方式中的特征可以相互补充或相互组合。The present invention will be described in detail below with reference to the accompanying drawings and preferred embodiments. The following embodiments and features of the embodiments may complement each other or be combined with each other unless there is any conflict.
如图1和图8所示，本发明优选实施例一提供一种瓣膜锚固件1(以下简称瓣膜锚固件1)，所述瓣膜锚固件1包括弹性丝11、容置部12和牵引体13；容置部12设置在弹性丝11的外部并与弹性丝11连接；容置部12沿着弹性丝11的整个延伸方向分布并具有空腔121，使容置部12的形状对应于弹性丝11的形状；牵引体13部分设置于容置部12的空腔121内，且牵引体13在容置部12对应于弹性丝11的远端的端部绕制成闭环后分成两部分，在容置部12的远端端部形成闭环后即作为施力点；此外，牵引体13的两部分在所述容置部12内沿着容置部12的轴线延伸，且牵引体13的两端在容置部12对应于弹性丝11的近端的端部伸出容置部12以方便操作者操作牵引体13。As shown in Figures 1 and 8, the first preferred embodiment of the present invention provides a valve anchor 1 (hereinafter referred to as the valve anchor 1). The valve anchor 1 includes an elastic wire 11, an accommodating portion 12 and a traction body 13 ; The accommodating portion 12 is arranged outside the elastic yarn 11 and connected to the elastic yarn 11; the accommodating portion 12 is distributed along the entire extension direction of the elastic yarn 11 and has a cavity 121, so that the shape of the accommodating portion 12 corresponds to the elastic yarn 11; the traction body 13 is partially disposed in the cavity 121 of the accommodating part 12, and the traction body 13 is divided into two parts after being wound into a closed loop at the end of the accommodating part 12 corresponding to the distal end of the elastic wire 11. The distal end of the accommodating part 12 forms a closed loop and serves as a force application point; in addition, the two parts of the traction body 13 extend along the axis of the accommodating part 12 in the accommodating part 12, and the two ends of the traction body 13 The accommodating portion 12 extends from the end portion of the accommodating portion 12 corresponding to the proximal end of the elastic wire 11 to facilitate the operator to operate the traction body 13 .
瓣膜锚固件1具有收缩状态和扩张状态，并能够在所述收缩状态和所述扩张状态之间切换。牵引体13能够被拉动，以控制瓣膜锚固件1的远端的移动方向。应理解，牵引体13在容置部12对应于弹性丝11的远端的端部绕制成闭环是指，牵引体13能够绕过瓣膜锚固件1的远端并分成两部分，而后牵引体13的两部分能够在空腔121中延伸，此时可通过拉动牵引体13的两端 而控制瓣膜锚固件1的远端的移动方向。The valve anchor 1 has a contracted state and an expanded state and is capable of switching between the contracted state and the expanded state. The traction body 13 can be pulled to control the movement direction of the distal end of the valve anchor 1 . It should be understood that the traction body 13 is wound into a closed loop at the end of the accommodating portion 12 corresponding to the distal end of the elastic wire 11 , which means that the traction body 13 can bypass the distal end of the valve anchor 1 and be divided into two parts, and then the traction body 13 can be wound into a closed loop. The two parts of 13 can be extended in the cavity 121. At this time, the two parts of the traction body 13 can be pulled And the movement direction of the distal end of the valve anchor 1 is controlled.
在本实施例中，牵引体13可活动地设置在容置部12的空腔121中，牵引体13的任意一端均能够被拉动，以使整个瓣膜锚固件1的远端朝预定方向移动，如使瓣膜锚固件1的远端回到当初预定型时的位置，从而使整个瓣膜锚固件1恢复到预定型时的形态。作为一优选实施例，在牵引体13的拉动下，整个瓣膜锚固件1的远端能够始终沿着预定腔室的腔壁移动，并使瓣膜锚固件1按照腔壁的形态收拢以定型。在瓣膜锚固件1完全扩张后，瓣膜锚固件1能够环绕预定对象的原生瓣叶定位，并且瓣膜锚固件1能够利用人工心脏瓣膜3固定在原生瓣环处。In this embodiment, the traction body 13 is movably disposed in the cavity 121 of the accommodating part 12, and either end of the traction body 13 can be pulled to move the distal end of the entire valve anchor 1 in a predetermined direction. For example, the distal end of the valve anchor 1 is returned to its original pre-shaped position, thereby restoring the entire valve anchor 1 to its pre-shaped shape. As a preferred embodiment, under the pulling of the traction body 13, the distal end of the entire valve anchor 1 can always move along the cavity wall of the predetermined chamber, and the valve anchor 1 can be gathered and shaped according to the shape of the cavity wall. After the valve anchor 1 is fully expanded, the valve anchor 1 can be positioned around the native valve leaflets of the intended subject, and the valve anchor 1 can be fixed at the native valve annulus using the artificial heart valve 3 .
在本实施例中，瓣膜锚固件1在扩张状态时为螺旋形状并具有用于容纳人工心脏瓣膜3的环形的内腔14。In this embodiment, the valve anchor 1 has a spiral shape in the expanded state and has an annular inner cavity 14 for accommodating the artificial heart valve 3 .
图8为本发明一具体实施例所涉及的人工心脏瓣膜3的应用场景。参见图8，植入体内后，以二尖瓣瓣膜置换为例，人工心脏瓣膜3部分容纳在环形的内腔14中，并通过人工心脏瓣膜3的扩张或结构将瓣膜锚固件1定位并固定在二尖瓣瓣环处。具体而言，瓣膜锚固件1的固定方式同人工心脏瓣膜3的结构有关。人工心脏瓣膜3可采用现有的结构，具体地，可包括相互连接的流出段31和瓣环段32，在某些情况下，人工心脏瓣膜还包括法兰段33，以提高人工心脏瓣膜3的锚固效果并防止瓣周漏的发生。所述流出段31、瓣环段32和法兰段33轴向依次连接，且人工心脏瓣膜3扩张后，流出段31和法兰段33的内径均大于瓣环段32的内径。当人工心脏瓣膜3为上述两头凸中间凹的结构(即腰形结构)时，人工心脏瓣膜3可以在扩张时不压紧瓣膜锚固件1，此时瓣膜锚固件1贴靠在人工心脏瓣膜的瓣环段32位置，并可通过人工心脏瓣膜3的流出段31和法兰段33卡在凹陷处。如果人工心脏瓣膜3为圆柱形或圆锥形时，可通过人工心脏瓣膜3的扩张将瓣膜锚固件1压紧在瓣环处，此时瓣膜锚固件1能够在受力变形时自适应扩张后的人工心脏瓣膜3的外部轮廓，以对人工心脏瓣膜3施加锚固力。Figure 8 shows an application scenario of the artificial heart valve 3 according to a specific embodiment of the present invention. Referring to Figure 8, after implantation in the body, taking mitral valve replacement as an example, the artificial heart valve 3 is partially accommodated in the annular inner cavity 14, and the valve anchor 1 is positioned and fixed through the expansion or structure of the artificial heart valve 3 At the mitral annulus. Specifically, the fixation method of the valve anchor 1 is related to the structure of the artificial heart valve 3 . The artificial heart valve 3 can adopt an existing structure. Specifically, it can include an interconnected outflow section 31 and an annulus section 32. In some cases, the artificial heart valve also includes a flange section 33 to improve the performance of the artificial heart valve 3. anchoring effect and prevent the occurrence of paravalvular leakage. The outflow section 31 , annulus section 32 and flange section 33 are connected axially in sequence, and after the artificial heart valve 3 is expanded, the inner diameters of the outflow section 31 and the flange section 33 are both larger than the inner diameter of the annulus section 32 . When the artificial heart valve 3 has the above-mentioned structure of convex at both ends and concave in the middle (i.e., waist-shaped structure), the artificial heart valve 3 can expand without compressing the valve anchor 1. At this time, the valve anchor 1 is close to the artificial heart valve. The valve annulus section 32 is positioned at the valve annulus section 32 and can be stuck in the depression through the outflow section 31 and the flange section 33 of the artificial heart valve 3 . If the artificial heart valve 3 is cylindrical or conical, the valve anchor 1 can be pressed against the annulus through expansion of the artificial heart valve 3. At this time, the valve anchor 1 can adapt to the expanded shape when deformed by force. The outer contour of the artificial heart valve 3 is used to exert anchoring force on the artificial heart valve 3 .
如更具体地，参照图1和图5所示，所述瓣膜锚固件1可放置在输送鞘管4中并随输送鞘管4移动至二尖瓣瓣环位置，而后瓣膜锚固件1在输送系 统的推动下可逐步移出输送鞘管4并在左心室中进行释放，瓣膜锚固件1在释放过程中通过拉动牵引体13来调整瓣膜锚固件1的远端的移动方向，从而可保证瓣膜锚固件1的远端始终按照预定方向移动，最终在牵引体13的控制下按照预定方向螺旋绕制成型并环绕原生瓣叶21。且在成型过程中，由牵引体13控制瓣膜锚固件1的远端的朝向，如此可使瓣膜锚固件1能够在移动时不受心脏周期性运动的干扰而始终平行于原生瓣环，从而保证瓣膜锚固件1在完全扩张后能够抓取全部的原生瓣叶21和腱索22等原生组织，避免受心脏解剖结构的影响滑向心尖方向或刺伤心肌，进而可提升人工心脏瓣膜3手术的可靠性和安全性。More specifically, as shown in FIGS. 1 and 5 , the valve anchor 1 may be placed in the delivery sheath 4 and moved to the mitral annulus with the delivery sheath 4 , and then the valve anchor 1 is delivered Tie The delivery sheath 4 can be gradually removed under the push of the system and released in the left ventricle. During the release process, the valve anchor 1 adjusts the moving direction of the distal end of the valve anchor 1 by pulling the traction body 13, thereby ensuring the valve anchoring. The distal end of the component 1 always moves in a predetermined direction, and is finally spirally wound in a predetermined direction under the control of the traction body 13 and surrounds the native valve leaflet 21 . And during the molding process, the traction body 13 controls the orientation of the distal end of the valve anchor 1, so that the valve anchor 1 can move without being disturbed by the periodic movement of the heart and always be parallel to the native valve annulus, thereby ensuring After the valve anchor 1 is fully expanded, it can grasp all the native valve leaflets 21 and chordae tendineae 22 and other native tissues to avoid being affected by the anatomical structure of the heart from sliding toward the apex or stabbing the myocardium, thereby improving the efficiency of the artificial heart valve 3 surgery. Reliability and security.
应理解，所述预定对象是指需要植入人工心脏瓣膜3的主体，预定对象一般指人体的心脏。所述预定腔室是指心脏中能够容纳并固定瓣膜锚固件1的腔室，如预定腔室是指人体的左心室或右心室。所述预定方向是指能够使瓣膜锚固件1环绕原生瓣叶21，且不会指向心尖或损伤心肌壁的瓣膜锚固件1的远端的移动方向，优选，所述预定方向为沿着预定腔室的腔壁的方向。It should be understood that the predetermined object refers to the subject who needs to be implanted with the artificial heart valve 3, and the predetermined object generally refers to the human heart. The predetermined chamber refers to a chamber in the heart that can accommodate and fix the valve anchor 1. For example, the predetermined chamber refers to the left ventricle or the right ventricle of the human body. The predetermined direction refers to the movement direction of the distal end of the valve anchor 1 that enables the valve anchor 1 to surround the native valve leaflet 21 and does not point toward the apex or damage the myocardial wall. Preferably, the predetermined direction is along the predetermined cavity. The direction of the chamber walls.
本发明实施例还提供一种瓣膜***，包括人工心脏瓣膜3以及瓣膜锚固件1，所述人工心脏瓣膜3用于容纳在瓣膜锚固件1中。该瓣膜***无需绳套结构抓捕引导丝，当瓣膜锚固件1为螺旋形状时也无需在瓣膜锚固件1上设计对接的紧固装置，如此可简化瓣膜锚固件1的植入过程，降低瓣膜锚固件1的植入难度，还能够提高人工心脏瓣膜3植入的成功率，进而可减少对患者的伤害。An embodiment of the present invention also provides a valve system, which includes an artificial heart valve 3 and a valve anchor 1 . The artificial heart valve 3 is used to be accommodated in the valve anchor 1 . This valve system does not require a rope structure to capture the guide wire. When the valve anchor 1 is in a spiral shape, there is no need to design a docking fastening device on the valve anchor 1. This can simplify the implantation process of the valve anchor 1 and reduce the cost of the valve. The difficulty of implanting the anchor 1 can also improve the success rate of implanting the artificial heart valve 3, thereby reducing harm to the patient.
优选，人工心脏瓣膜3的外径大于所述瓣膜锚固件1的内径，如此可在人工心脏瓣膜3植入后，瓣膜锚固件1能够在人工心脏瓣膜3扩张后受力变形，由于弹性丝11具有弹性，瓣膜锚固件1还能够在受力变形时自适应人工心脏瓣膜3的外部轮廓，并可通过瓣膜锚固件1与人工心脏瓣膜3之间的过盈配合对人工心脏瓣膜3施加锚固力，从而可使人工心脏瓣膜3能够更加牢固的与瓣膜锚固件1进行连接，还可通过瓣膜锚固件1为人工心脏瓣膜3提供锚固在心脏内的锚固力，以实现人工心脏瓣膜3在原生瓣叶21处的固定，即，使人工心脏瓣膜3通过瓣膜锚固件1固定在预定对象中。 Preferably, the outer diameter of the artificial heart valve 3 is larger than the inner diameter of the valve anchor 1, so that after the artificial heart valve 3 is implanted, the valve anchor 1 can be deformed by force after the artificial heart valve 3 expands, because the elastic wire 11 With elasticity, the valve anchor 1 can also adapt to the external contour of the artificial heart valve 3 when deformed by force, and can exert an anchoring force on the artificial heart valve 3 through the interference fit between the valve anchor 1 and the artificial heart valve 3 , so that the artificial heart valve 3 can be more firmly connected to the valve anchor 1, and the valve anchor 1 can also be used to provide the anchoring force for the artificial heart valve 3 to be anchored in the heart, so as to realize the anchoring force of the artificial heart valve 3 in the native valve. The fixation at the leaflet 21 means that the artificial heart valve 3 is fixed in a predetermined object through the valve anchor 1 .
进一步地，弹性丝11由弹性材料制成，弹性材料优选为具有形状记忆功能并为具有较强的弹性变形能力的材料，以确保弹性丝11可在轴向、径向或周向上进行较大程度的弹性变形。弹性丝11可预先进行定型处理为螺旋形状，如此可将弹性丝11沿延伸方向(即长度方向)拉伸并放置在输送鞘管4中。在瓣膜锚固件1释放时，弹性丝11可在逐步移出输送鞘管4的过程中恢复至螺旋形状，以使瓣膜锚固件1在扩张后能够形成螺旋形状并锚固在原生瓣叶21的位置。Furthermore, the elastic wire 11 is made of elastic material. The elastic material is preferably a material with a shape memory function and a strong elastic deformation ability to ensure that the elastic wire 11 can perform larger deformation in the axial, radial or circumferential direction. degree of elastic deformation. The elastic yarn 11 can be shaped into a spiral shape in advance, so that the elastic yarn 11 can be stretched along the extension direction (ie, the length direction) and placed in the delivery sheath 4 . When the valve anchor 1 is released, the elastic wire 11 can return to the spiral shape while gradually moving out of the delivery sheath 4 , so that the valve anchor 1 can form a spiral shape after expansion and be anchored at the position of the native valve leaflet 21 .
本申请对制备弹性丝11的弹性材料不做限定，只要是能够产生弹性变形的金属材料或高分子材料即可。如弹性丝11可设置为不锈钢、钛合金、镍钛合金中的一种或多种的组合，弹性丝11的材料还可设置为高分子材料，例如尼龙材料、聚酯纤维等。此外，每根弹性丝11可以由一种或多种材料组合制备而成，例如可将不同种类的材料段相互连接以形成弹性丝11。弹性丝11可以是实心或空心的结构，只要能够提供足够强的支撑力即可。同时弹性丝11的横截面形状不限定，如为圆形、环形或矩形，或者也可为变径或者变截面的设计，即弹性丝11在不同位置处的横截面的尺寸不同或形状不同，以满足瓣膜锚固件1的设计要求。This application does not limit the elastic material used to prepare the elastic yarn 11, as long as it is a metal material or polymer material that can produce elastic deformation. For example, the elastic wire 11 can be configured to be one or a combination of stainless steel, titanium alloy, and nickel-titanium alloy. The material of the elastic wire 11 can also be configured to be a polymer material, such as nylon material, polyester fiber, etc. In addition, each elastic thread 11 can be made of one or more combinations of materials, for example, different types of material segments can be connected to each other to form the elastic thread 11 . The elastic wire 11 can be a solid or hollow structure, as long as it can provide strong enough support. At the same time, the cross-sectional shape of the elastic yarn 11 is not limited, such as circular, annular or rectangular, or it can also be designed with variable diameter or variable cross-section, that is, the cross-sectional size or shape of the elastic yarn 11 at different positions is different. To meet the design requirements of valve anchor 1.
本申请对制备牵引体13的材料不做限定，牵引体13仅需满足能够进行拉伸和弯曲即可。本申请中的牵引体13可设置为金属丝、金属管或高分子聚合物线等，例如可将牵引体13设置为不锈钢丝、钛合金丝、镍钛合金丝中的一种或多种组合。为使牵引体13能够适应容置部12的空腔121的尺寸，可将牵引体13的直径设置为0.1mm～1.5mm，以方便牵引体13在容置部12的空腔121中的移动。This application does not limit the material used to prepare the traction body 13. The traction body 13 only needs to be able to be stretched and bent. The traction body 13 in this application can be configured as a metal wire, a metal tube or a polymer wire, etc. For example, the traction body 13 can be configured as one or more combinations of stainless steel wire, titanium alloy wire, and nickel-titanium alloy wire. . In order to enable the traction body 13 to adapt to the size of the cavity 121 of the accommodating part 12, the diameter of the traction body 13 can be set to 0.1 mm to 1.5 mm to facilitate the movement of the traction body 13 in the cavity 121 of the accommodating part 12. .
进一步地，所述容置部12内设置有供牵引体13穿设的多个独立设置的空腔121(见图1)，一根牵引体13穿过一个空腔121后在容置部12对应于弹性丝11的远端的端部弯曲后穿入另一个空腔121中。具体的，参照图1所示，每个空腔121为连续的腔体，牵引体13能够在容置部12的一个空腔121的近端穿入，并从该所述空腔121的远端穿出，而后牵引体13在容置部12对应于弹性丝11的远端的端部弯曲后从另一个空腔121的远端穿入，并从另 一个所述空腔121的近端穿出。需知晓，空腔121的近端对应于弹性丝11的近端，使容置部12的近端靠近弹性丝11的近端；空腔121的远端对应于弹性丝11的远端，使容置部12的远端靠近弹性丝11的远端。如此设置，当瓣膜锚固件1开始进行释放(如图5)，且瓣膜锚固件1的远端脱离预定方向移动并滑向心尖(如图6)时，操作者可拉动牵引体13的两端，以使瓣膜锚固件1的远端朝近端弯曲，从而使整个瓣膜锚固件1恢复到预定型时的螺旋形态并继续沿预定腔室的腔壁方向移动(如图7)，如此可在瓣膜锚固件1释放过程中对瓣膜锚固件1的远端的移动方向进行多次控制，直至使瓣膜锚固件1环绕原生瓣叶21。而在瓣膜锚固件1植入后，可抽离牵引体13，以使瓣膜锚固件1固定在原生瓣环的位置，从而完成瓣膜锚固件1的植入。需要说明的是，由于瓣膜锚固件1中的弹性丝11具有形状记忆功能，故瓣膜锚固件1在扩张后能够自动恢复至预定型时的螺旋形状。当瓣膜锚固件1的远端朝心尖方向移动时，拉动牵引体12的两端可使瓣膜锚固件1的远端弯曲，从而能够使瓣膜锚固件1继续沿预定腔室的腔壁方向移动。Furthermore, the accommodating part 12 is provided with a plurality of independently arranged cavities 121 (see Figure 1) for the traction body 13 to pass through. The end corresponding to the distal end of the elastic wire 11 is bent and then penetrated into another cavity 121 . Specifically, as shown in FIG. 1 , each cavity 121 is a continuous cavity, and the traction body 13 can penetrate into the proximal end of a cavity 121 of the accommodating part 12 and draw from the far end of the cavity 121 . The traction body 13 then passes through the distal end of the other cavity 121 after bending the end of the accommodating portion 12 corresponding to the distal end of the elastic wire 11, and passes through the distal end of the elastic wire 11 from the other end. The proximal end of one of the cavities 121 exits. It should be noted that the proximal end of the cavity 121 corresponds to the proximal end of the elastic wire 11, so that the proximal end of the accommodating portion 12 is close to the proximal end of the elastic wire 11; the distal end of the cavity 121 corresponds to the distal end of the elastic wire 11, so that The distal end of the accommodating portion 12 is close to the distal end of the elastic wire 11 . With this arrangement, when the valve anchor 1 begins to release (as shown in Figure 5) and the distal end of the valve anchor 1 moves away from the predetermined direction and slides toward the apex (as shown in Figure 6), the operator can pull both ends of the traction body 13 , so that the distal end of the valve anchor 1 is bent toward the proximal end, so that the entire valve anchor 1 returns to its predetermined spiral shape and continues to move along the wall direction of the predetermined chamber (as shown in Figure 7), so that it can be During the release process of the valve anchor 1, the moving direction of the distal end of the valve anchor 1 is controlled multiple times until the valve anchor 1 surrounds the native valve leaflet 21. After the valve anchor 1 is implanted, the traction body 13 can be pulled away so that the valve anchor 1 is fixed at the position of the native valve annulus, thereby completing the implantation of the valve anchor 1 . It should be noted that since the elastic wire 11 in the valve anchor 1 has a shape memory function, the valve anchor 1 can automatically return to its predetermined spiral shape after expansion. When the distal end of the valve anchor 1 moves toward the apex, pulling both ends of the traction body 12 can bend the distal end of the valve anchor 1, so that the valve anchor 1 can continue to move along the wall direction of the predetermined chamber.
在一些实施例中，参见图1和图2，所述牵引体13的数量为一根，容置部12包括两根并排设置的空腔管122，两根空腔管122均和弹性丝11平行设置，每根空腔管122具有一个空腔121，以使一根牵引体13的两部分分别穿设在两根空腔管122中。在一实施例中，两根空腔管122可分别与弹性丝11连接，例如可将两根空腔管122可设置在弹性丝11的两侧。在另一实施例中，两根空腔管122相互连接，且仅有一根空腔管122与弹性丝11连接，例如可将弹性丝11和一根空腔管122设置在另一根空腔管122的两侧。参照图1所示，在本实施例中，每根空腔管122分别与弹性丝11和另一根空腔管122连接，即弹性丝11和两根空腔管122形成类似三角形的结构(参照图1中弹性丝11和空腔管122的结构)，如此可减小瓣膜锚固件1的横截面尺寸，以方便输送***的输送。本文中，输送***是指瓣膜锚固件1或人工心脏瓣膜3的输送***，即是指能够携带压缩后的瓣膜锚固件1或人工心脏瓣膜3在预定对象(例如人体的心脏)内移动的设备。In some embodiments, referring to FIGS. 1 and 2 , the number of the traction bodies 13 is one, and the accommodating part 12 includes two hollow tubes 122 arranged side by side, and the two hollow tubes 122 are both connected to the elastic wire 11 Arranged in parallel, each hollow tube 122 has a cavity 121, so that two parts of one traction body 13 are respectively inserted into the two hollow tubes 122. In one embodiment, two hollow tubes 122 can be connected to the elastic wire 11 respectively. For example, the two hollow tubes 122 can be disposed on both sides of the elastic wire 11 . In another embodiment, two hollow tubes 122 are connected to each other, and only one hollow tube 122 is connected to the elastic wire 11. For example, the elastic wire 11 and one hollow tube 122 can be arranged in another cavity. both sides of tube 122. Referring to FIG. 1 , in this embodiment, each cavity tube 122 is connected to the elastic wire 11 and another cavity tube 122 respectively, that is, the elastic wire 11 and the two cavity tubes 122 form a triangle-like structure ( Referring to the structure of the elastic wire 11 and the cavity tube 122 in Figure 1), the cross-sectional size of the valve anchor 1 can be reduced to facilitate the delivery of the delivery system. In this article, the delivery system refers to the delivery system of the valve anchor 1 or the artificial heart valve 3, that is, it refers to a device that can carry the compressed valve anchor 1 or the artificial heart valve 3 to move within a predetermined object (such as the human heart) .
本申请对制备空腔管122的材料不做限定。如空腔管122可由强度较低 的高分子材料制成，例如聚乙烯、PU或聚四氟乙烯等。This application does not limit the material used to prepare the cavity tube 122 . For example, the hollow tube 122 can be made of a lower strength Made of polymer materials, such as polyethylene, PU or polytetrafluoroethylene.
在本实施例中，所述弹性丝11和空腔管122的长度相同，弹性丝11和空腔管122的位置相对应并能够在相接触的位置采用缝制、粘接或其它方式进行连接。In this embodiment, the lengths of the elastic wire 11 and the cavity tube 122 are the same. The elastic wire 11 and the cavity tube 122 are positioned correspondingly and can be connected by sewing, bonding or other methods at the contact positions. .
在另一些实施中，所述容置部12也可仅包括一根空腔管122，此时所述空腔管122内设置有供牵引体13穿设的一个空腔121，牵引体13在瓣膜锚固件1的远端形成闭环后(例如牵引体13穿过瓣膜锚固件1的远端的两个圆孔后)，进入空腔管122的空腔121中。In other implementations, the accommodating part 12 may also include only one hollow tube 122. In this case, the hollow tube 122 is provided with a cavity 121 for the traction body 13 to pass through. The traction body 13 is in After the distal end of the valve anchor 1 forms a closed loop (for example, after the traction body 13 passes through the two circular holes at the distal end of the valve anchor 1), it enters the cavity 121 of the cavity tube 122.
参照图3所示，在其他实施例中，所述牵引体13的数量为两根，容置部12包括沿弹性丝11依次分布的四根空腔管122，四根空腔管122均与弹性丝11平行设置，每根空腔管122具有一个空腔121，以使每根牵引体13的两部分分别穿设在对应的两根空腔管122中。在一实施例中，四根空腔管122可相互连接形成类似正方形的结构后与弹性丝11连接，此时仅有两根空腔管122与弹性丝11连接。在另一实施例中，四根空腔管122可均与弹性丝11和相邻一根空腔管122连接，此时四根空腔管122可相互连接形成类似正方形的结构后使弹性丝11***正方形结构中(参照图3中弹性丝11和空腔管122的结构)。故本申请对弹性丝11和弹性管15的放置位置不作限定。应理解，在上述的两根或四根空腔管122中，每根空腔管122的材质、尺寸和刚度可以相同，也可以不同。优选为相同，以方便牵引体13更好的对空腔管122的远端进行控制。Referring to FIG. 3 , in other embodiments, the number of the traction bodies 13 is two, and the accommodating part 12 includes four hollow tubes 122 sequentially distributed along the elastic wire 11 , and the four hollow tubes 122 are all connected with each other. The elastic wires 11 are arranged in parallel, and each cavity tube 122 has a cavity 121, so that two parts of each traction body 13 are respectively inserted into the corresponding two cavity tubes 122. In one embodiment, four hollow tubes 122 can be connected to each other to form a square-like structure and then connected to the elastic wire 11 . At this time, only two hollow tubes 122 are connected to the elastic wire 11 . In another embodiment, the four hollow tubes 122 can be connected to the elastic wire 11 and an adjacent hollow tube 122. In this case, the four hollow tubes 122 can be connected to each other to form a square-like structure, and then the elastic wires can be connected to each other. 11 is inserted into the square structure (refer to the structure of the elastic wire 11 and the cavity tube 122 in Figure 3). Therefore, this application does not limit the placement positions of the elastic wire 11 and the elastic tube 15 . It should be understood that among the two or four hollow tubes 122 mentioned above, the material, size and stiffness of each hollow tube 122 may be the same or different. Preferably, they are the same to facilitate the traction body 13 to better control the distal end of the hollow tube 122 .
优选的，当空腔管122为四根，且所述牵引体13的数量为两根时，每根牵引体13的两部分能够在容置部12对应于弹性丝11的远端的端部绕制成闭环并穿过不同的空腔121。在一实施例中，可将两根牵引体13在瓣膜锚固件1的远端交叉设置(参照图3)，此时每根牵引体13绕制成闭环后的两部分可分别穿过沿弹性丝11的轴向对称设置的两根空腔管122的空腔121中。如此设置，当瓣膜锚固件1开始进行释放(如图5)且瓣膜锚固件1的远端脱离预定方向移动并滑向心尖(如图6)时，操作者可固定一根牵引体13并拉动另一根牵引体13的两端，且拉动不同的牵引体13可使瓣膜锚固件1的远端朝 不同的方向移动，从而使牵引体13能够更有方向性的控制瓣膜锚固件1的远端移动。具体的，拉动不同的牵引体13可使瓣膜锚固件1的远端朝预定方向远离心房的方向或预定方向靠近心房的方向移动，以使瓣膜锚固件1的远端能够更准确的移动至预定型时的位置，并使瓣膜锚固件1的远端继续沿预定腔室的腔壁移动。Preferably, when there are four hollow tubes 122 and the number of the traction bodies 13 is two, the two parts of each traction body 13 can be wrapped around the end of the accommodation portion 12 corresponding to the distal end of the elastic wire 11 . A closed loop is made and passes through different cavities 121 . In one embodiment, two traction bodies 13 can be cross-arranged at the distal end of the valve anchor 1 (refer to Figure 3). At this time, the two parts of each traction body 13 wound into a closed loop can pass through the elastic edges respectively. The wire 11 is axially symmetrically arranged in the cavities 121 of the two cavity tubes 122 . With this arrangement, when the valve anchor 1 begins to release (as shown in Figure 5) and the distal end of the valve anchor 1 moves away from the predetermined direction and slides toward the apex (as shown in Figure 6), the operator can fix a traction body 13 and pull Two ends of another traction body 13, and pulling different traction bodies 13 can make the distal end of the valve anchor 1 move toward By moving in different directions, the traction body 13 can control the distal movement of the valve anchor 1 in a more directional manner. Specifically, pulling different traction bodies 13 can make the distal end of the valve anchor 1 move in a predetermined direction away from the atrium or in a predetermined direction close to the atrium, so that the distal end of the valve anchor 1 can move to the predetermined position more accurately. position, and the distal end of the valve anchor 1 continues to move along the wall of the predetermined chamber.
在另一实施例中，可将两根牵引体13在瓣膜锚固件1的远端平行设置，此时每根牵引体13绕制成闭环后的两部分可分别穿过相邻的空腔管122的空腔121中，此时操作者可固定其中的一根牵引体13并拉动另一根牵引体13的两端，即可使瓣膜锚固件1的远端移动至预定型时的位置，并使瓣膜锚固件1的远端继续沿预定腔室的腔壁移动。In another embodiment, two pulling bodies 13 can be arranged in parallel at the distal end of the valve anchor 1. In this case, the two parts of each pulling body 13 wound into a closed loop can pass through the adjacent cavity tubes respectively. 122 in the cavity 121, at this time the operator can fix one of the traction bodies 13 and pull both ends of the other traction body 13, so that the distal end of the valve anchor 1 can be moved to the predetermined position. And the distal end of the valve anchor 1 continues to move along the cavity wall of the predetermined cavity.
较优的，所述容置部12的远端端部密封设置，如此可方便牵引体13在空腔121内的移动，并可降低牵引体13进入或撤出输送***的阻力，还可降低瓣膜锚固件1的远端的血栓风险。在本实施例中，参照图2所示，所有空腔管122与预定腔室相接触的远端密封设置，例如可在空腔121的远端放置硅胶垫片以使瓣膜锚固件1的远端密封。Preferably, the distal end of the accommodating part 12 is sealed, which can facilitate the movement of the traction body 13 in the cavity 121, and can reduce the resistance of the traction body 13 entering or withdrawing from the delivery system, and can also reduce Risk of thrombosis distal to valve anchor 1. In this embodiment, as shown in FIG. 2 , all the distal ends of the cavity tubes 122 are in contact with the predetermined chamber. For example, a silicone gasket can be placed at the distal end of the cavity 121 to prevent the distal end of the valve anchor 1 . End seal.
更优选的，所述容置部12的远端端部闭合且形状为球形、圆锥形或椭圆形，如此设置一方面可以降低瓣膜锚固件1的植入带来的血栓风险；另一方面可使瓣膜锚固件1的远端能够平滑过渡，以防止瓣膜锚固件1的远端划伤心肌壁或心尖。More preferably, the distal end of the accommodating portion 12 is closed and has a spherical, conical or elliptical shape. Such an arrangement can on the one hand reduce the risk of thrombosis caused by the implantation of the valve anchor 1; on the other hand, it can The distal end of the valve anchor 1 can be smoothly transitioned to prevent the distal end of the valve anchor 1 from scratching the myocardial wall or the cardiac apex.
参照图4所示，在一些实施例中，所述容置部12包括沿弹性丝11的延伸方向间隔布置的多个容纳结构123，每个容纳结构123具有沿弹性丝11径向并排设置的至少两个通孔124，所有容纳结构123的通孔124组成至少两个空腔121，牵引体13沿弹性丝11的轴线依次穿过所有容纳结构123中的对应一排通孔124后，在容置部12对应于弹性丝11的远端的端部弯曲后又依次穿入所有容纳结构123中的对应另一排通孔124。在本实施例中，每个容纳结构123包括两个相互连接且均与弹性丝11连接的圆环，每个所述圆环具有一个通孔124，牵引体13依次穿过所有所述圆环中的对应一排通孔124后在对应于弹性丝11的远端弯曲后又依次穿入所有所述圆环中的对应另一排通孔 124，从而可降低空腔管122可能会带来的血栓风险。在其他实施例中，每个容纳结构123的两个所述圆环也可相分离并分别与弹性丝11相连接。所述容纳结构123不限于圆环，容纳结构123仅需包括两个并排设置的通孔124即可，本申请对容纳结构123的具体结构不作限定。Referring to FIG. 4 , in some embodiments, the accommodating portion 12 includes a plurality of accommodating structures 123 spaced apart along the extension direction of the elastic wire 11 , and each accommodating structure 123 has a plurality of accommodating structures 123 arranged side by side along the radial direction of the elastic wire 11 . There are at least two through holes 124, and the through holes 124 of all the accommodation structures 123 form at least two cavities 121. After the traction body 13 passes through the corresponding row of through holes 124 in all the accommodation structures 123 along the axis of the elastic wire 11, The end of the accommodating portion 12 corresponding to the distal end of the elastic wire 11 is bent and then penetrates into the corresponding other row of through holes 124 in all the accommodating structures 123 in sequence. In this embodiment, each receiving structure 123 includes two circular rings that are connected to each other and are both connected to the elastic wire 11. Each of the circular rings has a through hole 124, and the traction body 13 passes through all of the circular rings in sequence. The corresponding row of through holes 124 in the ring is bent and then penetrated into the corresponding another row of through holes in all the rings after being bent corresponding to the distal end of the elastic wire 11. 124, thereby reducing the risk of thrombosis that may be caused by the hollow tube 122. In other embodiments, the two rings of each containing structure 123 can also be separated and connected to the elastic wire 11 respectively. The accommodation structure 123 is not limited to a ring. The accommodation structure 123 only needs to include two through holes 124 arranged side by side. This application does not limit the specific structure of the accommodation structure 123 .
本申请对容纳结构123的数量也不做限定，容纳结构123的数量可根据需要进行设置。为使瓣膜锚固件1的远端能够得到较好的控制，可将瓣膜锚固件1的远端位置的容纳结构123之间的间距减小，或者增加瓣膜锚固件1的远端位置的容纳结构123的壁厚。本申请对容纳结构123与弹性丝11的连接方式不作限定，容纳结构123可以通过焊接、缝合或粘接的方式与弹性丝11连接。This application does not limit the number of accommodation structures 123, and the number of accommodation structures 123 can be set as needed. In order to better control the distal end of the valve anchor 1, the distance between the receiving structures 123 at the distal position of the valve anchor 1 can be reduced, or the receiving structure at the distal position of the valve anchor 1 can be increased. 123mm wall thickness. This application does not limit the connection method between the accommodation structure 123 and the elastic thread 11. The accommodation structure 123 can be connected to the elastic thread 11 by welding, sewing or gluing.
请继续参阅图1，在所述扩张状态下，瓣膜锚固件1具有用于环绕原生瓣叶21的锚固段15，锚固段15具有至少1匝线圈，此处的匝数即为锚固段15预定型时的绕制圈数。优选为2匝，如此可使锚固段15能够对人工心脏瓣膜3具有足够的锚固力，又能够在人工心脏瓣膜3扩张时发生变形而自适应人工心脏瓣膜3的外部轮廓，从而可通过瓣膜锚固件1实现对人工心脏瓣膜3的锚固。Please continue to refer to Figure 1. In the expanded state, the valve anchor 1 has an anchoring section 15 for surrounding the native valve leaflet 21. The anchoring section 15 has at least 1 turn of coil, and the number of turns here is the predetermined number of turns of the anchoring section 15. The number of winding turns when forming. It is preferably 2 turns, so that the anchoring section 15 can have sufficient anchoring force for the artificial heart valve 3, and can deform when the artificial heart valve 3 expands and adapt to the external contour of the artificial heart valve 3, so that it can be anchored by the valve. Part 1 realizes the anchoring of the artificial heart valve 3.
为使瓣膜锚固件1能够环绕原生瓣叶21，锚固段15的内径(即瓣膜锚固件1中内腔14的最大直径)通常对应于原生瓣叶21的尺寸，如在本实施例中，锚固段15的内轮廓的半径为5mm～20mm，并可根据不同的患者选择适配的瓣膜锚固件1。本申请对锚固段15的形状不作限定，优选锚固段15扩张后的外轮廓的形状与原生瓣叶21的内轮廓形状相对应，以实现更好的锚固，如锚固段15扩张后的形状可为圆形、圆弧形或椭圆形等。In order to enable the valve anchor 1 to surround the native valve leaflet 21, the inner diameter of the anchoring segment 15 (ie, the maximum diameter of the lumen 14 in the valve anchor 1) generally corresponds to the size of the native valve leaflet 21, as in this embodiment, the anchor The radius of the inner contour of the segment 15 is 5 mm to 20 mm, and a suitable valve anchor 1 can be selected according to different patients. This application does not limit the shape of the anchoring segment 15. It is preferred that the expanded outer contour shape of the anchoring segment 15 corresponds to the inner contour shape of the native valve leaflet 21 to achieve better anchoring. For example, the expanded shape of the anchoring segment 15 can be Be circular, arc or elliptical, etc.
在一实施例中，锚固段15可由一种材料的弹性丝11和一种材料的空腔管122绕制而成。在另一实施例中，锚固段15还可采用两种以上的材料的弹性丝11和两种以上材料的空腔管122分段连接而成，例如可将不同种类的材料的弹性丝11相互连接，并将不同种类的材料的空腔管122相互连接再将弹性丝11和空腔管122在径向上连接以形成锚固段15。In one embodiment, the anchoring segment 15 may be wound by an elastic wire 11 of one material and a hollow tube 122 of one material. In another embodiment, the anchoring section 15 can also be formed by connecting elastic wires 11 of two or more materials and hollow tubes 122 of more than two materials in sections. For example, the elastic wires 11 of different types of materials can be connected to each other. Connect, connect the cavity tubes 122 of different types of materials to each other, and then connect the elastic wire 11 and the cavity tube 122 in the radial direction to form the anchoring section 15 .
为增加锚固段15锚固时的摩擦力，即进一步增加瓣膜锚固件1在心脏内 的锚固效果，可在锚固段15的表面涂覆高摩擦系数的覆盖层。所述高摩擦系数的覆盖层可为聚乙烯和PET材料中的一种或多种的组合。In order to increase the friction when the anchoring segment 15 is anchored, that is, further increasing the position of the valve anchor 1 in the heart To improve the anchoring effect, a covering layer with a high friction coefficient can be coated on the surface of the anchoring section 15. The high friction coefficient covering layer may be one or a combination of polyethylene and PET materials.
参照图1和图5所示，在扩张状态下，所述瓣膜锚固件1优选还具有与锚固段15轴向连接的抓取段16，抓取段16的曲率半径大于锚固段15的曲率半径，以使瓣膜锚固件1植入时沿预定腔室的腔壁移动并扩张成型。由于抓取段16的半径较大，在瓣膜锚固件1在输送鞘管4内释放时，使得抓取段16能够始终紧贴预定腔室的腔壁，以使瓣膜锚固件1能够抓取所有的原生瓣叶21和腱索22等原生组织，并将在瓣膜锚固件1移动时将原生瓣叶21和腱索22等原生组织收容在内腔14内部(即环绕所有的原生瓣叶21和腱索22)，以确保人工心脏瓣膜3植入后能够紧贴原生瓣叶21。需要说明的是，当瓣膜锚固件1从腱索22中间穿过，即瓣膜锚固件1未能够将原生瓣叶21和腱索22收容在内腔14中时，由于此时部分腱索22组织位于瓣膜锚固件1的外部，使得人工心脏瓣膜3植入后不能紧贴部分原生瓣叶21，从而可导致瓣周漏的产生，并可能导致人工心脏瓣膜3手术的失败。Referring to Figures 1 and 5, in the expanded state, the valve anchor 1 preferably also has a grabbing section 16 axially connected to the anchoring section 15, and the radius of curvature of the grabbing section 16 is greater than the radius of curvature of the anchoring section 15. , so that the valve anchor 1 moves along the cavity wall of the predetermined cavity and expands and forms when implanted. Due to the larger radius of the grabbing section 16, when the valve anchor 1 is released in the delivery sheath 4, the grabbing section 16 can always be close to the wall of the predetermined chamber, so that the valve anchor 1 can grab all The native valve leaflets 21 and chordae tendineae 22 and other native tissues will be accommodated in the inner cavity 14 (that is, surrounding all the native valve leaflets 21 and tendineae) when the valve anchor 1 moves. Chordae tendineae 22) to ensure that the artificial heart valve 3 can closely adhere to the native valve leaflets 21 after implantation. It should be noted that when the valve anchor 1 passes through the middle of the chordae tendineae 22 , that is, when the valve anchor 1 fails to accommodate the native valve leaflets 21 and chordae tendineae 22 in the inner cavity 14 , due to the partial tissue of the chordae tendineae 22 at this time, Located outside the valve anchor 1 , the artificial heart valve 3 cannot adhere closely to part of the native valve leaflets 21 after implantation, which may cause paravalvular leakage and may lead to the failure of the artificial heart valve 3 operation.
当然，如果牵引体13有足够的强度，例如使用刚度较大的材料制备牵引体13或者增大制备牵引体13的材料的壁厚，此时可增大锚固段15各部位的曲率半径，以使锚固段15在释放后能够自行沿着预定腔室的腔壁移动。在瓣膜锚固件1完全植入后，抽离牵引体13，锚固段15能够自动恢复至预定型时的曲率半径较小的线圈结构而紧贴原生瓣叶21，此时瓣膜锚固件1可自适应人工心脏瓣膜3的外部轮廓并对人工心脏瓣膜3提供锚固力。如此设置，瓣膜锚固件1可减小抓取段16的初始曲率半径，或者使抓取段16的曲率半径与锚固段15的曲率半径相同，此时在瓣膜锚固件1植入后，抓取段16不会悬浮于预定腔室的内部，从而可有利于瓣膜锚固件1在人体内的长期植入。Of course, if the traction body 13 has sufficient strength, for example, using a material with higher stiffness to prepare the traction body 13 or increasing the wall thickness of the material used to prepare the traction body 13, the curvature radius of each part of the anchoring section 15 can be increased, so as to The anchoring segment 15 can move along the wall of the predetermined chamber by itself after being released. After the valve anchor 1 is completely implanted, the traction body 13 is withdrawn, and the anchoring segment 15 can automatically return to the predetermined coil structure with a smaller radius of curvature and closely adhere to the native valve leaflet 21. At this time, the valve anchor 1 can automatically Adapt to the external contour of the artificial heart valve 3 and provide anchoring force to the artificial heart valve 3 . With this arrangement, the valve anchor 1 can reduce the initial radius of curvature of the grasping section 16, or make the radius of curvature of the grasping section 16 the same as the radius of curvature of the anchoring section 15. At this time, after the valve anchor 1 is implanted, the grasping section 16 can The segment 16 will not be suspended inside the predetermined chamber, thereby facilitating long-term implantation of the valve anchor 1 in the human body.
为使抓取段16能够在移动时始终沿预定腔室的腔壁移动，抓取段16的曲率半径通常对应于预定腔室的尺寸，即抓取段16扩张后的外轮廓的半径与预定腔室的内轮廓的半径相对应，并可根据不同的患者选择适配的瓣膜锚固件1，如此可使瓣膜锚固件1能够紧贴预定腔室的腔壁移动而又不会较容易的***心肌壁内。 In order to enable the grasping section 16 to always move along the cavity wall of the predetermined chamber when moving, the radius of curvature of the grasping section 16 usually corresponds to the size of the predetermined cavity, that is, the radius of the expanded outer contour of the grasping section 16 is consistent with the predetermined size. The radius of the inner contour of the chamber corresponds, and the valve anchor 1 can be selected according to different patients, so that the valve anchor 1 can move closely against the wall of the predetermined chamber without being easily inserted. within the myocardial wall.
本申请对抓取段16的形状不作限定，抓取段16可为圆弧结构或线圈结构。当抓取段16为圆弧结构时，所述抓取段16可为单一圆弧组成，也可为多段圆弧连接而成，所述圆弧的长度可根据需要进行设定。其中，组成抓取段16的多段圆弧中各弧段的曲率半径为10mm～30mm，以更好的辅助瓣膜锚固件1抓取全部原生瓣叶21和腱索22等结构。当抓取段16为线圈结构时，所述线圈结构的匝数不超过2匝，以使抓取段16在牵引体13的拉动下能够较容易的变形而改变移动方向。This application does not limit the shape of the grabbing section 16. The grabbing section 16 can be an arc structure or a coil structure. When the grabbing section 16 has an arc structure, the grabbing section 16 can be composed of a single arc, or can be connected by multiple arcs, and the length of the arc can be set as needed. Among them, the curvature radius of each arc segment in the multiple arcs that make up the grasping section 16 is 10 mm to 30 mm, so as to better assist the valve anchor 1 in grasping all the native valve leaflets 21, chordae tendineae 22 and other structures. When the grabbing section 16 is a coil structure, the number of turns of the coil structure does not exceed 2, so that the grabbing section 16 can be easily deformed and change the moving direction under the pulling of the traction body 13 .
为减少抓取段16移动时的摩擦力，即进一步减少抓取段16移动时的阻力，可在抓取段16的表面涂覆低摩擦系数的覆盖层。所述低摩擦系数的覆盖层可为聚四氟乙烯或丝绒布中的一种或多种的组合。In order to reduce the friction force when the grabbing section 16 moves, that is, to further reduce the resistance when the grabbing section 16 moves, a covering layer with a low friction coefficient can be coated on the surface of the grabbing section 16 . The low friction coefficient covering layer may be one or a combination of polytetrafluoroethylene or velvet cloth.
在一示例中，可采用不同的弹性丝11和空腔管122分别制成锚固段15和抓取段16，并将锚固段15和抓取段16相互连接以形成瓣膜锚固件1，也即，锚固段15和抓取段16为分体制作成型后再相互连接。在其他示例中，也可采用相互连接的一根弹性丝11和一根空腔管122先后绕制形成锚固段15和抓取段16，以形成一体式的瓣膜锚固件1。In an example, different elastic wires 11 and hollow tubes 122 can be used to make the anchoring section 15 and the grabbing section 16 respectively, and the anchoring section 15 and the grabbing section 16 can be connected to each other to form the valve anchor 1, that is, , the anchoring section 15 and the grabbing section 16 are made separately and then connected to each other. In other examples, an elastic wire 11 and a cavity tube 122 connected to each other can also be wound successively to form the anchoring section 15 and the grabbing section 16 to form the integrated valve anchor 1 .
在一非限定实施例中，以二尖瓣瓣膜置换为例，所述瓣膜锚固件1和人工心脏瓣膜3的植入过程为：In a non-limiting embodiment, taking mitral valve replacement as an example, the implantation process of the valve anchor 1 and the artificial heart valve 3 is:
参照图5～图8所示，将瓣膜锚固件1收缩在输送鞘管4中，输送鞘管4可经由主动脉、心房或其他路径进入到左心室中，随后可将瓣膜锚固件1推送至输送鞘管4的鞘管口，并在左心室中开始瓣膜锚固件1的释放。首先，先从输送鞘管4中推送出瓣膜锚固件1的抓取段16，由于瓣膜锚固件1的经过预定型后的抓取段16的曲率半径较大，抓取段16在心室中移动时可沿腔壁前进。如图6所示，当瓣膜锚固件1受到心室壁的运动干扰或瓣膜锚固件1的远端进入心肌纵向的缝隙内时，瓣膜锚固件1的远端可能滑向心尖的方向，此时停止瓣膜锚固件1的推进，并通过拉动牵引体13的两端使得瓣膜锚固件1的远端脱离心肌壁并回到预定型时的位置，并重新使瓣膜锚固件1的远端与原生瓣环平行，以便瓣膜锚固件1的远端能够继续沿预定腔室的腔壁移动。而后继续推进瓣膜锚固件1，在瓣膜锚固件1释放过程中，若瓣膜锚固件1的 远端再次朝心尖方向移动，可再次拉动牵引体13以调整瓣膜锚固件1的远端的移动方向，如此反复操作，直至瓣膜锚固件1能够环绕所有的原生瓣叶21和腱索22等原生组织。在确认瓣膜锚固件1已完全脱离输送鞘管4并能够环绕原生瓣叶21时，使输送***保持瓣膜锚固件1的位置，并开始进行人工心脏瓣膜3的植入。Referring to Figures 5 to 8, the valve anchor 1 is contracted in the delivery sheath 4. The delivery sheath 4 can enter the left ventricle via the aorta, atrium or other paths, and then the valve anchor 1 can be pushed to the left ventricle. The sheath port of sheath 4 is delivered and release of valve anchor 1 is initiated in the left ventricle. First, the grasping section 16 of the valve anchor 1 is pushed out from the delivery sheath 4. Since the pre-shaped grasping section 16 of the valve anchor 1 has a large curvature radius, when the grasping section 16 moves in the ventricle, Can advance along the cavity wall. As shown in Figure 6, when the valve anchor 1 is disturbed by the movement of the ventricular wall or the distal end of the valve anchor 1 enters the longitudinal gap of the myocardium, the distal end of the valve anchor 1 may slide toward the apex of the heart and stop at this time. By advancing the valve anchor 1 and pulling both ends of the traction body 13, the distal end of the valve anchor 1 is separated from the myocardial wall and returned to the predetermined position, and the distal end of the valve anchor 1 is reconnected with the native valve annulus. parallel, so that the distal end of the valve anchor 1 can continue to move along the wall of the predetermined chamber. Then continue to advance the valve anchor 1. During the release process of the valve anchor 1, if the valve anchor 1 The distal end moves toward the apex again, and the traction body 13 can be pulled again to adjust the moving direction of the distal end of the valve anchor 1. This operation is repeated until the valve anchor 1 can surround all the native valve leaflets 21 and chordae tendineae 22 and other native valves. organize. When it is confirmed that the valve anchor 1 has completely separated from the delivery sheath 4 and can surround the native valve leaflets 21 , the delivery system is allowed to maintain the position of the valve anchor 1 and the implantation of the artificial heart valve 3 begins.
所述人工心脏瓣膜用以置换和替代天然二尖瓣瓣膜。人工心脏瓣膜3可经由下腔静脉或其他路径进入心房，并跨越原生瓣叶21进入到瓣膜锚固件1的内腔14中；所述人工心脏瓣膜3能够通过球囊一次性球扩或采用自膨退鞘等方式进行扩径，在此扩径时瓣膜锚固件1中的锚固段15会产生弹性变形或塑性变形，且锚固段15在发生变形时可自适应人工心脏瓣膜3中瓣环段32的形状，并充分的与瓣环段32固定连接且密封，从而使瓣膜锚固件1与人工心脏瓣膜3固定连接为一个整体。锚固段15能够对扩张后的人工心脏瓣膜3施加锚固力，以实现人工心脏瓣膜3在原生瓣叶21位置的锚固。The artificial heart valve is used to replace and replace the natural mitral valve. The artificial heart valve 3 can enter the atrium via the inferior vena cava or other pathways, and cross the native valve leaflets 21 into the inner cavity 14 of the valve anchor 1; the artificial heart valve 3 can be expanded by a balloon or by a self-contained valve. The diameter of the anchoring segment 15 in the valve anchor 1 will be elastically deformed or plastically deformed during the diameter expansion, and the anchoring segment 15 can adapt to the annular segment of the artificial heart valve 3 when deformed. 32, and is fully fixedly connected and sealed with the valve annulus segment 32, so that the valve anchor 1 and the artificial heart valve 3 are fixedly connected as a whole. The anchoring section 15 can exert an anchoring force on the expanded artificial heart valve 3 to achieve anchoring of the artificial heart valve 3 at the position of the native valve leaflets 21 .
如图8所示，以腰形的人工心脏瓣膜3为例，人工心脏瓣膜3包括轴向依次连接的流出段31、瓣环段32和法兰段33，且在人工心脏瓣膜3扩张后，流出段31和法兰段33的内径均大于瓣环段32的内径。在瓣膜锚固件1和人工心脏瓣膜3植入后，需要调整瓣膜锚固件1和人工心脏瓣膜3的植入位置，以使瓣膜锚固件1位于人工心脏瓣膜3的瓣环段32的位置，并使瓣膜锚固件1环绕并贴靠原生瓣叶21，此时扩张后人工心脏瓣膜3可对瓣膜锚固件1提供在预定对象内的锚固力。同时半径较大的流出段31和法兰段33可对人工心脏瓣膜3的瓣环段32进行轴向上的限位，即，使瓣环段32仅能够位于瓣膜锚固件1的位置处，从而确保人工心脏瓣膜3植入后不能够在轴向上发生移动。待人工心脏瓣膜3完全扩张后，操作者通过确认人工心脏瓣膜3与瓣膜锚固件1已牢固植入预定位置后可抽出牵引体13并撤出输送***，从而完成人工心脏瓣膜3及瓣膜锚固件1的植入手术。As shown in Figure 8, taking the waist-shaped artificial heart valve 3 as an example, the artificial heart valve 3 includes an outflow section 31, an annulus section 32 and a flange section 33 that are connected in sequence in the axial direction. After the artificial heart valve 3 is expanded, The inner diameters of the outflow section 31 and the flange section 33 are both larger than the inner diameter of the annulus section 32 . After the valve anchor 1 and the artificial heart valve 3 are implanted, the implantation positions of the valve anchor 1 and the artificial heart valve 3 need to be adjusted so that the valve anchor 1 is located at the annular segment 32 of the artificial heart valve 3, and The valve anchor 1 is made to surround and abut against the native valve leaflets 21. At this time, the expanded artificial heart valve 3 can provide the valve anchor 1 with anchoring force within a predetermined object. At the same time, the outflow section 31 and the flange section 33 with a larger radius can limit the annular section 32 of the artificial heart valve 3 in the axial direction, that is, the annular section 32 can only be located at the position of the valve anchor 1. This ensures that the artificial heart valve 3 cannot move in the axial direction after implantation. After the artificial heart valve 3 is fully expanded, the operator can extract the traction body 13 and withdraw the delivery system after confirming that the artificial heart valve 3 and the valve anchor 1 have been firmly implanted in the predetermined position, thereby completing the artificial heart valve 3 and the valve anchor. 1 implant surgery.
还应理解，本发明实施例提供的瓣膜***，可包括任一实施例中提供的瓣膜锚固件1。It should also be understood that the valve system provided by the embodiments of the present invention may include the valve anchor 1 provided in any embodiment.
综上，本发明提供的瓣膜锚固件1及瓣膜***中，具有弹性丝11的瓣膜 锚固件1能够被逐步扩张并在扩张后环绕原生瓣叶，瓣膜锚固件1还能够在扩张过程中通过牵引体13调整瓣膜锚固件1的远端的移动方向，如此可确保瓣膜锚固件1能够始终沿预定腔室的腔壁移动，还可使瓣膜锚固件1能够在移动时不受心脏周期性运动的干扰而始终平行于原生瓣环，从而保证瓣膜锚固件1在完全扩张后能够抓取全部的原生瓣叶21和腱索22等原生组织，避免受心脏解剖结构的影响滑向心尖方向或刺伤心肌，进而可提升人工心脏瓣膜3手术的可靠性和安全性。此外，该瓣膜***无需绳套结构抓捕引导丝，如此可简化瓣膜锚固件1的植入过程，降低瓣膜锚固件1的植入难度，还能够提高人工心脏瓣膜3植入的成功率，进而可减少对患者的伤害并有利于患者的术后康复。In summary, in the valve anchor 1 and the valve system provided by the present invention, the valve with the elastic wire 11 The anchor 1 can be gradually expanded and surround the native valve leaflets after expansion. The valve anchor 1 can also adjust the movement direction of the distal end of the valve anchor 1 through the traction body 13 during the expansion process, thus ensuring that the valve anchor 1 can Always moving along the wall of the predetermined chamber also allows the valve anchor 1 to move without being disturbed by the periodic movement of the heart and always parallel to the native valve annulus, thereby ensuring that the valve anchor 1 can grasp after full expansion. All native valve leaflets 21 and chordae tendineae 22 and other native tissues can avoid being affected by the anatomical structure of the heart from sliding toward the apex or puncturing the myocardium, thereby improving the reliability and safety of the artificial heart valve 3 surgery. In addition, the valve system does not require a rope structure to capture the guide wire, which can simplify the implantation process of the valve anchor 1, reduce the difficulty of implanting the valve anchor 1, and also improve the success rate of artificial heart valve 3 implantation, thus It can reduce harm to patients and facilitate their postoperative recovery.
本发明提供的瓣膜锚固件1包括锚固段15，所述锚固段15可通过内腔14与人工心脏瓣膜3之间的过盈配合来实现人工心脏瓣膜3与锚固段15的连接，并对人工心脏瓣膜3的施加锚固力。在瓣膜锚固件1植入后，抽离牵引体13，瓣膜锚固件1可自适应人工心脏瓣膜3的外部轮廓，从而可使人工心脏瓣膜3通过瓣膜锚固件1固定在预定对象中。The valve anchor 1 provided by the present invention includes an anchoring section 15. The anchoring section 15 can realize the connection between the artificial heart valve 3 and the anchoring section 15 through the interference fit between the inner cavity 14 and the artificial heart valve 3. The applied anchoring force of heart valve 3. After the valve anchor 1 is implanted, the traction body 13 is withdrawn, and the valve anchor 1 can adapt to the external contour of the artificial heart valve 3, so that the artificial heart valve 3 can be fixed in a predetermined object through the valve anchor 1.
上述描述仅是对本发明较佳实施例的描述，并非对本发明范围的任何限定，本发明领域的普通技术人员根据上述揭示内容做的任何变更、修饰，均属于本发明的保护范围。 The above description is only a description of the preferred embodiments of the present invention, and does not limit the scope of the present invention in any way. Any changes or modifications made by those of ordinary skill in the field of the present invention based on the above disclosures fall within the protection scope of the present invention.

Claims (10)

  1. 一种瓣膜锚固件，其特征在于，所述瓣膜锚固件具有收缩状态和扩张状态，并能够在所述收缩状态和所述扩张状态之间切换；A valve anchor, characterized in that the valve anchor has a contracted state and an expanded state, and can be switched between the contracted state and the expanded state;
    所述瓣膜锚固件包括弹性丝、容置部和牵引体；所述容置部设置在所述弹性丝的外部并与所述弹性丝连接；所述容置部沿着所述弹性丝的延伸方向分布并具有空腔；The valve anchor includes an elastic wire, an accommodating part and a traction body; the accommodating part is arranged outside the elastic wire and connected to the elastic wire; the accommodating part extends along the elastic wire Directionally distributed and with cavities;
    所述牵引体部分地设置于所述容置部的空腔内，并在所述容置部对应于所述弹性丝的远端的端部绕制成闭环后分成两部分，所述两部分在所述容置部内沿着所述容置部的轴线延伸，且所述牵引体的两端在所述容置部对应于所述弹性丝的近端的端部伸出所述容置部；所述牵引体能够被拉动，以控制所述瓣膜锚固件的远端的移动方向。The traction body is partially disposed in the cavity of the accommodating part, and is divided into two parts after the end of the accommodating part corresponding to the distal end of the elastic wire is wound into a closed loop, and the two parts Extends along the axis of the accommodation part in the accommodation part, and the two ends of the traction body extend out of the accommodation part at the end of the accommodation part corresponding to the proximal end of the elastic wire. ; The traction body can be pulled to control the movement direction of the distal end of the valve anchor.
  2. 如权利要求1所述的瓣膜锚固件，其特征在于，所述瓣膜锚固件为螺旋形状，并具有用于容纳人工心脏瓣膜的环形的内腔；所述瓣膜锚固件能够在受力变形时自适应扩张后的所述人工心脏瓣膜的外部轮廓，以对所述人工心脏瓣膜施加锚固力。The valve anchor according to claim 1, wherein the valve anchor is in a spiral shape and has an annular inner cavity for accommodating an artificial heart valve; the valve anchor can automatically deform when subjected to force. The outer contour of the expanded artificial heart valve is adapted to apply an anchoring force to the artificial heart valve.
  3. 如权利要求2所述的瓣膜锚固件，其特征在于，在所述扩张状态下，所述瓣膜锚固件具有用于环绕原生瓣叶的锚固段，所述锚固段具有至少一匝线圈，所述瓣膜锚固件还具有与所述锚固段轴向连接的抓取段；所述抓取段的曲率半径大于所述锚固段的曲率半径，以使所述瓣膜锚固件植入时沿预定腔室的腔壁移动并扩张成型。The valve anchor according to claim 2, wherein in the expanded state, the valve anchor has an anchoring section for surrounding the native valve leaflet, the anchoring section has at least one turn of coil, and the The valve anchor also has a grabbing section axially connected to the anchoring section; the radius of curvature of the grabbing section is greater than the radius of curvature of the anchoring section, so that when the valve anchor is implanted, it will be along the predetermined cavity. The cavity walls move and expand to form.
  4. 如权利要求1-3任一项所述的瓣膜锚固件，其特征在于，所述容置部内设置有供所述牵引体穿设的独立设置的多个空腔，一根所述牵引体穿过一个所述空腔后在所述容置部对应于所述弹性丝的远端的端部弯曲后穿入另一个所述空腔。The valve anchor according to any one of claims 1 to 3, characterized in that the accommodation part is provided with a plurality of independently arranged cavities for the traction body to pass through, and one of the traction bodies passes through After passing through one of the cavities, the end of the accommodating portion corresponding to the distal end of the elastic wire is bent and then penetrated into another of the cavities.
  5. 如权利要求4所述的瓣膜锚固件，其特征在于，所述牵引体的数量为一根，所述容置部包括两根并排设置的空腔管，两根所述空腔管均与所述弹性丝平行设置，两根所述空腔管相互连接和/或与所述弹性丝连接，每根所述空 腔管具有一个所述空腔，以使一根所述牵引体的两部分分别穿设在两根所述空腔管中。The valve anchor of claim 4, wherein the number of the traction bodies is one, and the accommodating part includes two hollow tubes arranged side by side, and both of the two hollow tubes are connected to the The elastic wires are arranged in parallel, and the two hollow tubes are connected to each other and/or to the elastic wires, and each of the hollow tubes is The lumen tube has one cavity, so that two parts of one traction body are respectively inserted into the two cavity tubes.
  6. 如权利要求4所述的瓣膜锚固件，其特征在于，所述牵引体的数量为两根，所述容置部包括沿所述弹性丝周向依次分布的四根空腔管，四根所述空腔管均与所述弹性丝平行设置，四根所述空腔管相互连接和/或与所述弹性丝连接，每根所述空腔管具有一个所述空腔，以使每根所述牵引体的两部分分别穿设在对应的两根所述空腔管中。The valve anchor of claim 4, wherein the number of the traction bodies is two, and the accommodating portion includes four hollow tubes distributed sequentially along the circumferential direction of the elastic wire. The hollow tubes are all arranged parallel to the elastic wires, and the four hollow tubes are connected to each other and/or to the elastic wires. Each of the hollow tubes has one cavity, so that each of the hollow tubes has one cavity. The two parts of the traction body are respectively inserted into the corresponding two hollow tubes.
  7. 如权利要求4所述的瓣膜锚固件，其特征在于，所述容置部的远端端部密封设置。The valve anchor according to claim 4, wherein the distal end of the accommodating portion is sealed.
  8. 如权利要求7所述的瓣膜锚固件，其特征在于，所述容置部的远端端部的形状为球形、圆锥形或椭圆形。The valve anchor according to claim 7, wherein the shape of the distal end of the receiving portion is spherical, conical or elliptical.
  9. 如权利要求4所述的瓣膜锚固件，其特征在于，所述容置部包括沿所述弹性丝的延伸方向间隔布置的多个容纳结构，每个所述容纳结构具有沿所述弹性丝的径向并排设置的至少两个通孔，所有所述容纳结构的所述通孔组成至少两个所述空腔，所述牵引体沿所述弹性丝的轴线依次穿过所有所述容纳结构中的一排所述通孔后，在所述容置部对应于所述弹性丝的远端的端部弯曲后又依次穿入所有所述容纳结构中的另一排所述通孔。The valve anchor according to claim 4, wherein the accommodation portion includes a plurality of accommodation structures spaced apart along the extension direction of the elastic wire, each of the accommodation structures having a shape along the elastic wire. At least two through holes arranged radially side by side, the through holes of all the accommodation structures constitute at least two of the cavities, the traction body passes through all the accommodation structures in sequence along the axis of the elastic wire After one row of the through holes, the end of the accommodating portion corresponding to the distal end of the elastic wire is bent and then penetrated into another row of the through holes in all the accommodating structures.
  10. 一种瓣膜***，其特征在于，包括人工心脏瓣膜以及如权利要求1-9中任一项所述的瓣膜锚固件，所述人工心脏瓣膜用于容纳在所述瓣膜锚固件中。 A valve system, characterized by comprising an artificial heart valve and a valve anchor as claimed in any one of claims 1 to 9, wherein the artificial heart valve is used to be accommodated in the valve anchor.
PCT/CN2023/075373 2022-05-06 2023-02-10 Valve anchoring member and valve system WO2023213107A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202210487351.4A CN117045394A (en) 2022-05-06 2022-05-06 Valve anchor and valve system
CN202210487351.4 2022-05-06

Publications (1)

Publication Number Publication Date
WO2023213107A1 true WO2023213107A1 (en) 2023-11-09

Family

ID=88646212

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2023/075373 WO2023213107A1 (en) 2022-05-06 2023-02-10 Valve anchoring member and valve system

Country Status (2)

Country Link
CN (1) CN117045394A (en)
WO (1) WO2023213107A1 (en)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160184095A1 (en) * 2013-08-14 2016-06-30 Mitral Valve Technologies Sarl Replacement heart valve apparatus and methods
CN106572905A (en) * 2014-02-20 2017-04-19 米特拉尔维尔福科技有限责任公司 Coiled anchor for supporting prosthetic heart valve, prosthetic heart valve, and deployment device
CN109803610A (en) * 2016-08-26 2019-05-24 爱德华兹生命科学公司 Heart valve docking system
CN112315626A (en) * 2020-11-06 2021-02-05 上海纽脉医疗科技有限公司 Artificial heart valve and medical device
CN112804966A (en) * 2018-08-21 2021-05-14 施菲姆德控股有限责任公司 Prosthetic heart valve devices, systems, and methods
CN113303947A (en) * 2021-06-17 2021-08-27 上海臻亿医疗科技有限公司 Anchoring device for heart valve

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160184095A1 (en) * 2013-08-14 2016-06-30 Mitral Valve Technologies Sarl Replacement heart valve apparatus and methods
CN106572905A (en) * 2014-02-20 2017-04-19 米特拉尔维尔福科技有限责任公司 Coiled anchor for supporting prosthetic heart valve, prosthetic heart valve, and deployment device
CN109803610A (en) * 2016-08-26 2019-05-24 爱德华兹生命科学公司 Heart valve docking system
CN109789019B (en) * 2016-08-26 2021-10-29 爱德华兹生命科学公司 Heart valve paired wire ring and system
CN112804966A (en) * 2018-08-21 2021-05-14 施菲姆德控股有限责任公司 Prosthetic heart valve devices, systems, and methods
CN112315626A (en) * 2020-11-06 2021-02-05 上海纽脉医疗科技有限公司 Artificial heart valve and medical device
CN113303947A (en) * 2021-06-17 2021-08-27 上海臻亿医疗科技有限公司 Anchoring device for heart valve

Also Published As

Publication number Publication date
CN117045394A (en) 2023-11-14

Similar Documents

Publication Publication Date Title
US20230034126A1 (en) System And Method For Cardiac Valve Repair And Replacement
JP6637409B2 (en) Catheter guide replacement valve device and method
US7241310B2 (en) Method and apparatus for reducing mitral regurgitation
US20080319538A1 (en) Kit to be implanted in a blood circulation conduit
JP2018504214A (en) Expandable epicardial pads and devices and methods for their delivery
WO2023155538A1 (en) Anchoring devices of artificial heart valve and artificial heart valve system
EP4003229B1 (en) Device for implanting a prosthesis for a heart valve
JP2008534085A (en) Apparatus, system, and method for reshaping a heart valve annulus
CN113303947A (en) Anchoring device for heart valve
US20230285146A1 (en) Device for arranging guidewires around a heart valve
CN114449978A (en) In vitro cardiac bypass shunt
CN215130906U (en) Anchoring device, replacement device and replacement system for heart valve
WO2023213107A1 (en) Valve anchoring member and valve system
WO2023213106A1 (en) Anchoring device of artificial heart valve and artificial heart valve system
EP4003234B9 (en) Device for arranging guide wires around a heart valve
US20210251749A1 (en) Device for implanting a prosthesis for a heart valve and assembly procedure
WO2022262117A1 (en) Anchoring device for heart valve
WO2022166063A1 (en) Anchoring device and artificial heart valve device
US20210402171A1 (en) Apparatus, control device, kit for supporting the heart action, insertion system, and method

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 23799097

Country of ref document: EP

Kind code of ref document: A1