CN215937817U

CN215937817U - Artificial valve device capable of being intervened and replaced

Info

Publication number: CN215937817U
Application number: CN202122295326.XU
Authority: CN
Inventors: 彭博
Original assignee: Fuwai Hospital of CAMS and PUMC; Fuwai Yunnan Cardiovascular Hospital
Current assignee: Fuwai Hospital of CAMS and PUMC; Fuwai Yunnan Cardiovascular Hospital
Priority date: 2021-09-22
Filing date: 2021-09-22
Publication date: 2022-03-04
Anticipated expiration: 2031-09-22

Abstract

The utility model relates to the field of medical equipment, and particularly discloses a prosthetic valve device capable of being intervened and replaced, which comprises a bracket, a valve frame and at least two valve leaflets; the support is of an elastic tubular structure, and can be compressed and deformed along the axial direction when being subjected to radial acting force and can be restored to the original shape after the radial acting force disappears; the valve frame is of an elastic annular structure or an elastic tubular structure, is coaxially fixed in the bracket and can be compressed and deformed together with the bracket, and a blood flow channel is arranged in the valve frame; each valve leaflet is a hard sheet-shaped structure, each valve leaflet is detachably connected with the valve frame, and each valve leaflet can rotate in the blood flow channel after being connected with the valve frame, so that each valve leaflet can open and close the blood flow channel. The mechanical valve has the structural advantages of a mechanical valve, and can be implanted in an interventional mode so as to reduce the trauma to a patient during implantation and reduce the surgical risk.

Description

Artificial valve device capable of being intervened and replaced

Technical Field

The utility model relates to the field of medical instruments, in particular to a prosthetic valve device capable of being intervened and replaced.

Background

Heart valves include mitral, tricuspid, aortic, and pulmonary valves; taking the human mitral valve as an example, the mitral valve is a bivalve type valve, which is located between the left atrium and the left ventricle; at diastole, left atrial pressure increases due to blood filling, and as atrial pressure increases and exceeds left ventricular pressure, the mitral valve opens, helping passive blood flow into the left ventricle; as atrial systole ends, allowing residual blood to flow from the left atrium into the left ventricle; the mitral valve closes after the atrial contraction is over to prevent backflow of blood from the left ventricle to the left atrium; the mitral valve includes an anterior leaflet and a posterior leaflet, collectively covering the opening of the mitral valve; the opening of the mitral valve is surrounded by an annulus of fibers, referred to as the mitral annulus; two leaflets attach circumferentially to the mitral annulus and open and close like annular hinges during the cardiac cycle; in a normally functioning mitral valve, the leaflets are connected by chordae tendineae to the papillary muscles of the left ventricle; when the left ventricle contracts, the pressure in the ventricle forces the mitral valve to close, and the chordae tendineae ensure the two leaflets to coapt, preventing them from prolapsing into the left atrium and causing mitral insufficiency, and preventing the valves from misorienting, thus preventing blood from flowing back into the left atrium.

Valvular disease is one of the common valvular heart diseases, the causes of the valvular disease include rheumatic, degenerative and infectious endocarditis, and the like, and artificial valve replacement is a common treatment means for treating the valvular heart disease. Prosthetic valves can be broadly divided into biological valve structures and mechanical valve structures; the biological valve is usually manufactured by treating human or porcine or bovine heart valves (or synthesized by using flexible artificial materials), and has the advantages that after operation, long-term administration of anticoagulation medicines is not needed, the possibility of anticoagulation complications is low, the influence on daily life is small, but the structural strength is low, the durability is poor, the use safety is low, and the service life is short (generally 10 to 15 years); the mechanical valve is mainly made of metal or pyrolytic carbon synthetic materials, has high structural strength, good durability and long service life (can be used for the whole life), and has high use safety as a whole although anticoagulant medicines need to be taken.

For the artificial valves with the two structures, in the existing clinical practice, the mechanical valve is implanted in an open-chest manner without exception, namely, the open sternotomy is performed, the heart is stopped by using an extracorporeal circulation machine, and the mechanical artificial valve is implanted, so that the trauma to a patient is large and the surgical risk is high; the biological valve can be implanted by adopting a less invasive intervention mode, for example, patent CN 109009569 a discloses an intervention replacement device of an artificial mitral valve and an intervention method thereof, which comprises a support body and an artificial valve leaflet, wherein the support body is made of deformable material, the artificial valve leaflet is made of biological or non-biological flexible material, the artificial valve leaflet is provided with a first end and a free end, the first end is connected with the lower edge of the support body, the free end is opposite to the first end, and the artificial valve leaflet is provided with an open configuration and a closed configuration; the diastolic artificial leaflets being in the open configuration with the free ends of each artificial leaflet moving away from each other into the left ventricle to allow antegrade blood to flow through the openings between the leaflets; the left ventricle systole artificial valve leaf is in closed configuration, the free end of each artificial valve leaf moves towards the left atrium direction, and the support bodies are closed and closed by mutually combining, thus preventing retrograde blood from flowing through.

As mentioned above, if the emphasis of the patient to replace the prosthetic valve is on the lifespan and safety of the valve, the mechanical valve should be considered first, but the defect of open-chest implantation often becomes an obstacle to the application of the mechanical valve; accordingly, there is a need for an interventional replacement prosthetic valve device that has the structural advantages of a mechanical valve and can be implanted by way of an intervention to reduce trauma to the patient during implantation and reduce surgical risks.

SUMMERY OF THE UTILITY MODEL

In view of the above, the present invention provides a prosthetic valve device capable of interventional replacement, which has the structural advantages of a mechanical valve and can be implanted in an interventional manner to reduce the trauma to a patient during implantation and reduce the risk of surgery.

In order to achieve the above purpose, the utility model provides a prosthetic valve device capable of interventional replacement, which comprises a bracket, a valve frame and at least two valve leaflets;

the support is of an elastic tubular structure, and can be compressed and deformed along the axial direction when being subjected to radial acting force and can be restored to the original shape after the radial acting force disappears;

the valve frame is of an elastic annular structure or an elastic tubular structure, is coaxially fixed in the bracket and can be compressed and deformed together with the bracket, and a blood flow channel is arranged in the valve frame;

each valve leaflet is a hard sheet-shaped structure, each valve leaflet is detachably connected with the valve frame, and each valve leaflet can rotate in the blood flow channel after being connected with the valve frame, so that each valve leaflet can open and close the blood flow channel.

As a further improvement of the technical scheme of the utility model, the stent comprises a stent body and a coating, wherein the stent body is woven by shape memory alloy wires and is of a net structure, and the coating is arranged on the outer side surface of part or all of the stent body.

As a further improvement of the technical scheme of the utility model, the covering film is made of terylene.

As a further improvement of the technical scheme of the utility model, the stent is provided with an anchor, and the anchor is used for anchoring the stent in a body.

As a further improvement to the technical scheme of the utility model, the valve frame is sewn on the bracket; the valve leaflet is made of pyrolytic carbon.

As a further improvement of the technical scheme of the utility model, each valve leaf is rotatably connected with a valve leaf shaft and is connected with a valve leaf frame through the valve leaf shaft.

As a further improvement of the technical scheme of the utility model, two ends of the blade shaft are respectively provided with an axial positioning groove, the positioning rod is coaxially and slidably arranged in the positioning groove, and an elastic reset piece is arranged between the inner end of the positioning rod and the bottom of the positioning groove; and a positioning hole which is matched with the positioning rod and used for inserting the positioning rod is arranged in the valve frame.

As a further improvement of the technical scheme of the utility model, the elastic reset piece is of a compression spring structure.

As a further improvement of the technical solution of the present invention, the flap frame is connected with a first developing member, the vane shaft is connected with a second developing member, and both the first developing member and the second developing member are used for developing under X-rays.

As a further improvement of the technical scheme of the utility model, the first developing part and the second developing part are both in a permanent magnet structure, the first developing part is embedded in the positioning hole, and the second developing part is arranged at the outer end of the positioning rod.

Compared with the prior art, the utility model has the following beneficial technical effects:

the valve leaflet of the valve prosthesis device used as the opening and closing part is of a hard sheet structure, and the structural strength of the valve prosthesis device is high, so that the valve prosthesis device capable of being intervened and replaced has the structural advantage of a mechanical valve; simultaneously, elastic support and elastic lamella frame can compress in step, and two rotatable foldings of valve leaf to make each part all can implant through the mode of intervening, effectively reduced the wound that causes the patient when implanting, reduced the operation risk.

In the case of replacing the mitral valve, when in use, the valve frame and the stent are connected and compressed, then the assembly is conveyed between the left atrium and the left ventricle of the patient through the apex of the heart, after the stent is released, the original mitral valve can be expanded and fixed on the endocardium, and the valve leaves in the folded state are conveyed into the valve frame through the apex of the heart and are connected and fixed, thus completing the installation of the whole artificial mitral valve device.

It should be noted that the present interventional replacement prosthetic valve device may be used in a variety of heart valve replacement procedures, including mitral valve.

Through the artificial valve device capable of being intervened and replaced, the artificial valve with the mechanical valve structure can be implanted in an intervening mode, which is the creative contribution of the utility model, and the existing mechanical valves are implanted in an open chest mode; therefore, the utility model meets the social needs, has strong practicability and is beneficial to promoting the further development of cardiovascular medical technology.

Drawings

FIG. 1 is a schematic structural view of the present invention;

fig. 2 is a schematic view of the connection structure of the valve frame and the valve leaflet of the present invention;

FIG. 3 is a schematic view of a first connection structure of a leaflet and a leaflet shaft according to the present invention;

fig. 4 is a schematic view of a second connection structure of the leaflet and the leaflet shaft of the present invention;

fig. 5 is a schematic structural view of a leaflet of the present invention;

fig. 6 is a schematic view of the structure of the blade shaft of the present invention.

Detailed Description

In order to make the technical solutions of the present invention better understood, the following detailed description of the present invention is provided with reference to the accompanying drawings and specific embodiments; of course, the drawings are simplified schematic drawings, and the scale of the drawings does not limit the patented products.

Examples

As shown in fig. 1 to 6: the present embodiment provides a prosthetic valve device capable of interventional replacement, which includes a stent 1, a valve frame 2, and two valve leaflets 3 (the number of the valve leaflets 3 may be two or more, such as three or four, and the present embodiment is described by taking two as an example).

The present embodiment is exemplified by the application of the valve device to the replacement of a human mitral valve, and in fact the device may be applied to the replacement of other valves as well.

The stent 1 is of an elastic tubular structure, and the stent 1 can be compressed and deformed along the axial direction when being subjected to radial acting force and can be restored to the original shape after the radial acting force disappears; preferably, the stent 1 comprises a stent body 11 and a coating film 12, wherein the stent body 11 is woven by shape memory alloy wires and has a net structure, and the coating film 12 is arranged on the outer side surface of part or all of the stent body 11; the cover film 12 may be made of dacron.

The stent 1 can be further provided with an anchor (not shown in the figure), and the anchor is used for anchoring the stent 1 in the body to realize the positioning of the stent 1; without limitation to the shape of the anchors, the "clamping effect" produced by the atrial flange and the annular support as in CN104771247A, "a device and method for treating mitral regurgitation"; for example, the anchoring element and hook structure in CN107405194A "mitral valve prosthesis" can achieve the purpose of this embodiment.

The valve frame 2 is of an elastic annular structure (or an elastic tubular structure), the valve frame 2 is coaxially fixed in the support 1 and can be compressed and deformed together with the support 1, a blood flow channel 2a is arranged in the valve frame 2, the blood flow channel 2a is used for blood flow to pass through, can be coaxially arranged with the blood flow channel 2a and is arranged in the middle of the blood flow channel 2 a; the flap frame 2 can be made of rubber, for example; the valve frame 2 can be connected to the bracket 1 by a sewing mode. After the device is positioned, the valve frame 2 can be positioned at the native mitral valve annulus.

Each of the valve leaflets 3 is a hard sheet-shaped structure, each of the valve leaflets 3 is detachably connected to the valve frame 2, and each of the valve leaflets 3 can rotate in the blood flow channel 2a after being connected to the valve frame 2, so that each of the valve leaflets 3 can open and close the blood flow channel 2 a. The valve leaflet 3 can be in a D shape, the principle of opening and closing the blood flow channel 2a by the valve leaflet 3 is the same as the action principle of the existing mechanical valve, and the details are not repeated; the leaflet 3 is preferably made of pyrolytic carbon.

The valve leaflet 3 serving as the opening and closing component of the artificial valve device capable of being intervened and replaced provided by the embodiment is of a hard sheet structure, and the structural strength is high, so that the artificial valve device capable of being intervened and replaced has the structural advantage of a mechanical valve; simultaneously, elastic support 1 and elastic lamella frame 2 can compress in step, and two rotatable foldings of valve leaf 3 to make each part all can implant through the mode of intervening, effectively reduced the wound that causes the patient when implanting, reduced the operation risk.

When the artificial mitral valve device is used, the valve frame 2 and the support 1 can be connected and compressed firstly, then the assembly is conveyed between the left atrium and the left ventricle of a patient through the apex of the heart (in fig. 1, the left atrium area is arranged above the valve frame 2, and the left ventricle area is arranged below the valve frame 2), the support 1 can expand the original mitral valve and is fixed on the endocardium after being released, and then the valve leaves 3 in a folded state are conveyed into the valve frame 2 through the apex of the heart and are connected and fixed, thus the installation of the whole artificial mitral valve device is completed.

In this embodiment, the leaflet 3 and the valve frame 2 can be connected by the following structure, for example.

Each valve leaf 3 is rotatably connected to a leaf shaft 4 and is connected with the valve frame 2 through the leaf shaft 4; the blade shaft 4 is in a circular rod structure, and the two valve blades 3 are symmetrically arranged by taking the axis of the blade shaft 4 as a symmetry axis; the straight line section of the D-shaped valve leaflet 3 can protrude outwards to form a rotating shaft 31, the side surface of the valve shaft 4 is correspondingly provided with a rotating groove 41, the rotating shaft 31 is clamped into the rotating groove 41 and can be rotatably connected, and meanwhile, the rotating groove 41 can also be used as a limiting component of the rotating shaft 31, so that the rotating angle of the valve leaflet 3 is limited (the opening degree of the valve leaflet 3 in the figures 1 and 3 is minimum, the blood flow channel 2a is completely closed, the opening degree of the valve leaflet 3 in the figures 2 and 4 is maximum, the two valve leaflets are nearly parallel, and the blood flow channel 2a is completely opened) so as to effectively open and close the blood flow channel 2 a.

Two ends (namely the upper end and the lower end in fig. 6) of the blade shaft 4 are respectively provided with an axial positioning groove 42, and the positioning groove 42 is formed by inward sinking of the end surface of the blade shaft 4; the positioning rods 5 are coaxially and slidably arranged in the corresponding positioning grooves 42, that is, the two positioning rods 5 are respectively arranged corresponding to the two positioning grooves 42; an elastic reset piece 6 is arranged between the inner end of the positioning rod 5 and the bottom of the positioning groove 42; the elastic restoring member 6 is preferably a compression spring structure, and both ends of the elastic restoring member 6 are fixedly connected to the inner end of the positioning rod 5 and the bottom of the positioning slot 42, respectively, so that when the positioning rod 5 is subjected to an axial acting force, the elastic restoring member 6 can be compressed to extend into the positioning slot 42, and after the axial acting force disappears, the positioning rod 5 is restored and extends out of the positioning slot 42.

A positioning hole 21 which is matched with the positioning rod 5 and used for inserting the positioning rod 5 is arranged in the flap frame 2; the two positioning holes 21 are distributed on one diameter of the valve frame 2 and can be of a through hole structure; based on the direction shown in fig. 1, the upper and lower end surfaces of the petal frame 2 are both smooth arc structures, so that when the vane shaft 4 enters the petal frame 2 from top to bottom or from bottom to top, the positioning rod 5 contacts the inner wall of the petal frame 2 and is subjected to an axial acting force (for the petal frame 2, the radial acting force is applied), so that the elastic resetting piece 6 can be compressed; when the positioning rod 5 is aligned with the positioning hole 21, the positioning rod 5 automatically extends into the positioning hole 21, so as to realize automatic locking.

Simultaneously, the petal frame 2 is connected with first development 61, the leaf axle 4 is connected with second development 62, first development 61 and second development 62 all are used for developing under the X line, can know the position of petal frame 2 and leaf axle 4 in the patient is internal from this, are convenient for intervene going on of operation. Preferably, the first developing part 61 and the second developing part 62 are both permanent magnet structures, the first developing part 61 is embedded in the positioning hole 21, the second developing part 62 is arranged at the outer end of the positioning rod 5, and the positioning rod 5 can also be made of a permanent magnet; the first developing member 61 and the second developing member have opposite magnetism, and therefore, the first developing member and the second developing member attract each other when they approach each other, which is not only advantageous for positioning the vane shaft 4, but also improves the connection stability of the positioning rod 5.

Finally, the principle and embodiments of the present invention are explained by using specific examples, and the above descriptions of the examples are only used to help understand the core idea of the present invention, and the present invention can be modified and modified without departing from the principle of the present invention, and the modified and modified examples also fall into the protection scope of the present invention.

Claims

1. A prosthetic valve device for interventional replacement, characterized by:

comprises a bracket, a valve frame and at least two valve blades;

2. An interventional replacement prosthetic valve device of claim 1, wherein:

the stent comprises a stent body and a film, wherein the stent body is woven by shape memory alloy wires and is of a net structure, and the film is arranged on the outer surface of part or all of the stent body.

3. An interventional replacement prosthetic valve device of claim 2, wherein:

the covering film is made of terylene.

4. An interventional replacement prosthetic valve device of claim 1, wherein:

the bracket is provided with an anchoring part, and the anchoring part is used for anchoring the bracket in a body.

5. An interventional replacement prosthetic valve device of claim 1, wherein:

the valve frame is sewed on the bracket; the valve leaflet is made of pyrolytic carbon.

6. An interventional replacement prosthetic valve device as claimed in any one of claims 1 to 5, wherein:

each valve leaf is rotatably connected to the leaf shaft and is connected with the valve frame through the leaf shaft.

7. An interventional replacement prosthetic valve device of claim 6, wherein:

two ends of the blade shaft are respectively provided with an axial positioning groove, the positioning rods are coaxially and slidably arranged in the positioning grooves, and an elastic reset piece is arranged between the inner ends of the positioning rods and the bottoms of the positioning grooves; and a positioning hole which is matched with the positioning rod and used for inserting the positioning rod is arranged in the valve frame.

8. An interventional replacement prosthetic valve device of claim 7, wherein:

the elastic reset piece is of a compression spring structure.

9. An interventional replacement prosthetic valve device of claim 7, wherein:

the petal frame is connected with a first developing piece, the leaf shaft is connected with a second developing piece, and the first developing piece and the second developing piece are both used for developing under X-rays.

10. An interventional replacement prosthetic valve device of claim 9, wherein:

first development spare and second development spare are the permanent magnet structure, the locating hole is located to first development spare inlay, the locating lever outer end is located to the second development spare.