阅读说明：本技术 一种经导管房室瓣膜置换系统 (Transcatheter atrioventricular valve replacement system ) 是由 戴宇峰 潘炳跃 王智杰 于 2021-01-20 设计创作，主要内容包括：本发明公开了一种经导管房室瓣膜置换系统,瓣膜置换系统包括瓣膜支架,人工瓣叶,锚定件,覆膜以及固定环。所述的固定环为圆圈状的环形结构,可为一圈或者多圈,采用经导管植入的方法,盘绕在二尖瓣或三尖瓣腱索丛,将各个瓣叶下的腱索从外周向中心拉拢。所述瓣膜支架,包括本体支架、心房盘面、连接件。所述的锚定件,为若干个连接在本体支架的反折向心房侧的末端圆钝的结构,可钩住固定环而固定瓣膜支架。本发明通过预先植入的固定环拉拢瓣膜下的腱索,可避免左心室流出道梗阻风险,并降低植入人工瓣膜系统尺寸,采用大的倒钩锚定元件,固定牢靠,瓣膜释放过程简单容易,可经静脉系统植入,创伤性小。(The invention discloses a transcatheter atrioventricular valve replacement system, which comprises a valve bracket, an artificial valve leaf, an anchoring piece, a covering film and a fixing ring. The fixing ring is a circular ring-shaped structure, can be in a circle or a plurality of circles, is coiled around the chordae tendineae of the mitral valve or the tricuspid valve by adopting a method of implantation through a catheter, and draws the chordae tendineae under each valve leaflet from the periphery to the center. The valve support comprises a body support, an atrium plate surface and a connecting piece. The anchoring piece is a plurality of structures which are connected with the body support and are blunt at the tail end of the atrium side in a reverse bending way, and the anchoring piece can hook the fixing ring to fix the valve support. The invention can avoid the risk of obstruction of the outflow tract of the left ventricle and reduce the size of the implanted artificial valve system by pulling the chordae tendineae under the valve through the pre-implanted fixing ring, adopts the large barb anchoring element, is firm in fixation, simple and easy in the valve releasing process, can be implanted through a venous system, and has small wound.)

1. A transcatheter atrioventricular valve replacement system, comprising: the system comprises a valve stent (10), an artificial valve leaflet (20), an anchor (30) and a fixing ring (40); the fixing ring (40) is of a circle-shaped ring structure or a plurality of circles; the valve support (10) comprises a body support (11), an atrium plate surface (12) and a connecting piece (13); the anchoring piece (30) is a plurality of blunt end structures which are connected with the reverse-folding atrium side of the body support (11).

2. The system of claim 1, wherein: the fixing ring (40) is made of metal or high polymer materials, is of an open-loop structure outside the body, is conveyed through a catheter after being straightened, and becomes an annular structure after being released after being conveyed into the body.

3. The system according to claim 1 or 2, characterized in that: the fixation ring (40) is radiographically active so that it can be seen by an X-ray machine during surgery.

4. The system of claim 1, wherein: the body bracket (11) is of a cylindrical or approximately cylindrical bracket structure with a wide upper part and a narrow lower part.

5. The system of claim 1, wherein: the atrium disk surface (12) is a disc-shaped structure extending towards the periphery of the atrium end of the body support, is connected with the body support (11) and is used for fixing the atrium side of the valve support and preventing paravalvular leakage.

6. The system of claim 1, wherein: the connecting piece (13) is a structure which is connected with a plurality of atrium side protrusions on the atrium side of the body support and is used for being connected with the delivery system in a detachable mode.

7. The system of claim 6, wherein: the connecting piece (13) is in a circular, oval or ear-shaped structure.

8. The system of claim 1, wherein: the anchoring piece (30) is of a structure with one end being a blunt free tail end and the other end being connected to the ventricle side of the body support (11) and reversely folded towards the atrium side, and the whole anchoring piece is in a strip cable shape, a triangle shape, a lug shape, an S shape or an oval shape, and the number of the anchoring pieces is 2-6.

9. The system of claim 8, wherein: the free ends of the anchoring elements (30) are designed close to the atrium disk (12) in the axial direction of the body support (11) and close to the body support (11) in the radial cross section of the body support (11), so that the artificial valve is prevented from being implanted too high towards the atrium side.

10. The system according to claim 8 or 9, characterized in that: the anchor (30) has a shape memory property and is made of a shape memory metal; in a conveying state, the anchoring piece (30) is pulled to the lateral direction of the heart chamber to be axially connected with the body support in series, so that the size of the conveying conduit is reduced; after release, the working state can recover the memory shape, and the heart is folded back to the atrium side and is close to the atrium disk surface (12) and the body support (11).

11. The system of claim 1, wherein: the body support (11) and the atrial disc surface (12) of the valve support (10) are net-shaped supports formed by combining a plurality of rhombic grid-shaped units.

12. The system according to claim 1 or 11, characterized in that: the valve stent (10) is made of memory alloy and has shape memory and self-expansion properties; the valve stent (10) can be compressed into a delivery catheter outside the body and expanded to restore the working state after being in the body.

13. The system of claim 12, wherein: the valve support (10) is integrally formed by laser cutting.

14. The system of claim 12, wherein: the anchoring member (30) and the body support (11) are independent structures and are connected with each other in a physical connection mode.

15. The system of claim 1, wherein: the artificial valve leaflet (20) is an artificial valve which is sewn in the cavity of the body support (11), is a three-leaflet valve and is made of bovine pericardium, porcine pericardium or high polymer materials.

16. The system of claim 1, wherein: the system also comprises a covering film, wherein the covering film is made of a biocompatible high polymer material and covers the periphery of the body support (11) and the atrial disc surface (12) to prevent paravalvular leakage.

Technical Field

The invention belongs to the field of medical equipment, and particularly relates to a mitral valve or tricuspid valve transcatheter atrioventricular valve replacement system.

Background

Valvular heart disease is one of the common cardiovascular diseases, mainly aortic valve, mitral valve and tricuspid valve diseases and the like. In people over 75 years of age, the incidence of valvular heart disease is 13%. Traditional treatment approaches include surgical valve replacement and repair. However, surgery has the disadvantages of high trauma, high risk, high incidence of complications, and so on, and transcatheter valve replacement is currently the promising direction. For transcatheter aortic valve and pulmonary artery replacement, the prior art is relatively mature and widely applied in clinic. However, the transcatheter replacement of atrioventricular valves (mitral valve and tricuspid valve) has not been widely popularized and applied clinically at present, because the transcatheter replacement of atrioventricular valves, especially mitral valve, faces many difficulties.

The current fixation of transcatheter replacement products for atrioventricular valves relies mostly on the radial support of prosthetic valve stents, in combination with anchors such as Intrepid products from Meindoli corporation (CN 105101911A) in FIG. 1, Fortis products from Edward corporation in FIG. 2, CardiaQ products (CN 102639179B, CN 105188611B, CN 107735053A, CN 111970995A), Network medical Mithos (CN 106175987A, CN 109106470A), Xeno medical products (CN 105658179A, CN 108578016A), and other patents CN 108135696A, CN 105188611B, CN 107106297A. Although the design can firmly fix the artificial valve support, on one hand, the implanted valve presses the left ventricle outflow tract to cause obstruction of the left ventricle outflow tract, which is a life complication risk, on the other hand, the size of the implanted valve support is overlarge, the implantation through the blood vessel is difficult to realize, the implantation can only be performed through the apex of the heart, and the trauma is still large.

Further, CN103917194A and CN106470641B in fig. 3 provide a new atrioventricular valve design, wherein an external circular element (collecting member) is first implanted under the mitral valve by catheter, and then a radially self-expandable tubular valve with circumferential grooves at its waist is delivered as the valve body to the circular element by catheter, so that the grooves are stuck on the external circular element to fix the valve. This design avoids the risk of obstruction of the left ventricular outflow tract, while reducing the size of the implanted valve, since the outer circular element has gathered the subvalvular chordae. However, this device requires the groove to be released at the position of the outer circular element when the valve is released, which is very demanding for valve release positioning, and secondly, due to the anatomical limitations of the heart, the depth of the circumferential groove is limited, which may cause the lumen inside the stent to be irregular and influence blood flow, which may lead to the outer circular element and the circumferential groove possibly dislocating each other, especially when the valve is not fully expanded during the valve release process, which may lead to the risk of valve displacement. While CN106470641B added short barbs outside the outer circular elements and grooves reduced this risk, these barbs were shorter and less secure and risked damage to the heart during implantation.

In conclusion, the existing system has the defects of easy occurrence of left ventricular outflow obstruction, overlarge valve model, high positioning difficulty in release and the like.

Disclosure of Invention

In order to overcome the defects of the prior art, the invention aims to provide a mitral valve or tricuspid valve transcatheter atrioventricular valve replacement system which can overcome the defects of obstruction of left ventricular outflow tract, overlarge valve model, high positioning difficulty during release and the like.

The purpose of the invention is realized by adopting the following technical scheme:

a transcatheter atrioventricular valve replacement system, the system comprising a valve stent, a prosthetic leaflet, an anchor, and a fixation ring; the fixing ring is of a circular ring-shaped one-circle or multi-circle annular structure; the valve support comprises a body support, an atrial disc surface and a connecting piece; the anchoring piece is a plurality of blunt end structures which are connected with the body support and are reversely folded towards the atrium side.

Preferably, the fixing ring is made of metal or high polymer materials, is of an open-loop structure outside the body, is conveyed through a catheter after being straightened, and becomes the loop structure after being released after being conveyed into the body.

Preferably, the fixation ring has a radiographic activity so that the fixation ring is visible by an X-ray machine during surgery.

Preferably, the body support is cylindrical or a cylinder-like structure with a wide upper part and a narrow lower part.

Preferably, the atrium disk surface is a disk-like structure extending towards the periphery of the atrium end of the body support, is connected with the body support and is used for fixing the atrium side of the valve support and preventing paravalvular leakage.

Preferably, the connecting member is a structure of a plurality of atrium side protrusions connected to the atrium side of the body frame and is used for being detachably connected with the delivery system.

Preferably, the connecting member has a circular, oval or ear-like configuration.

Preferably, the anchoring piece is of a structure with one end being a blunt free end and the other end being connected to the ventricle side of the body support and being reversely folded towards the atrium side, and the anchoring piece is integrally in a strip cable shape, a triangular shape, a lug shape, an S shape or an oval shape, and the number of the anchoring pieces is 2-6.

Preferably, the free ends of the anchoring elements are designed close to the atrial disc surface in the axial direction of the body support and close to the body support in the radial cross section of the body support, so that the artificial valve is prevented from being implanted too high towards the atrium side.

Preferably, the anchor has a shape memory property and is made of a shape memory metal; in a conveying state, the anchoring piece is pulled to the lateral direction of the heart chamber to be axially connected with the body support in series, so that the size of the conveying conduit is reduced conveniently; after releasing, the working state can recover the memory shape, and the heart room side is reversely folded and is close to the heart room disk surface and the body support.

Preferably, the main body support and the atrial disc surface of the valve support are net-shaped supports formed by combining a plurality of rhombic grid-shaped units.

Preferably, the valve stent is made of memory alloy and has shape memory and self-expansion properties; the valve stent can be compressed into a delivery catheter outside the body and expanded to restore the working state after being in the body.

Preferably, the valve support is integrally formed by laser cutting.

Preferably, the anchoring member and the body support are independent structures and are connected with each other in a physical connection mode.

Preferably, the artificial valve leaflet is an artificial valve sewn in the cavity of the body stent, is a trefoil valve and is made of bovine pericardium, porcine pericardium or high polymer materials.

Preferably, the system also comprises a covering film which is made of a biocompatible polymer material and covers the periphery of the body support and the atrial disc surface to prevent paravalvular leakage.

Compared with the prior art, the invention has the beneficial effects that: the pre-implanted fixing ring can avoid the risk of obstruction of the outflow tract of the left ventricle and reduce the size of the implanted artificial valve system by drawing the chordae tendineae under the valve to enable the valve leaflets to be close; the artificial valve adopts a large barb fixing element, so that the fixation is firm, meanwhile, the fixing element is released to hook the fixing ring firstly, and then the whole valve is released, so that the valve releasing process is simple and easy; the fixing ring is of a simple smooth annular structure, is easy to manufacture and implant and has small damage to the heart; the whole system can be implanted through blood vessels, and the trauma to the human body is minimal. .

Drawings

FIG. 1 is a diagram of the prior art Intrepid product from Meindonley;

FIG. 2 is a diagram of Fortis and CardiaQ products of Edward in the prior art;

FIG. 3 is a schematic diagram of a product of patent CN106470641 from high-quality life simplified shares company;

FIG. 4 is a schematic structural diagram of a ring-shaped retaining ring according to an embodiment of the present invention;

FIG. 5 is a front view of the embodiment of FIG. 4;

FIG. 6 is a top view of the embodiment shown in FIG. 4;

FIG. 7 is a schematic view of the retaining ring of the embodiment of FIG. 4;

FIG. 8 is a schematic view of the embodiment of FIG. 4 without the retaining ring;

FIG. 9 is a schematic structural diagram of an embodiment of a closed loop with one turn of the retaining ring;

FIG. 10 is a schematic structural view of an embodiment in which the fixing ring has a plurality of rings;

FIG. 11 is a schematic view of a multi-turn retaining ring;

fig. 12 is an operational schematic.

In the figure:

100. a transcatheter atrioventricular valve replacement system;

10. a valve stent; 11. a body support; 12. the atrial disc surface; 13. a connecting member;

20. artificial valve leaflets;

30. an anchor;

40. a fixing ring; 41. a ring body; 42. a positioning ring head; 43. and positioning the tail end.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are some, but not all, embodiments of the present invention. All other embodiments, which can be obtained by a person skilled in the art without any inventive step based on the embodiments of the present invention, are within the scope of the present invention.

A transcatheter atrioventricular valve replacement system 100 includes a valve stent 10, prosthetic leaflets 20, anchors 30, and a securing ring 40.

Valve stent

The valve stent 10 includes a body stent 11, an atrial disc surface 12, and a connector 13.

The main body support 11 and the atrial disc 12 of the valve support 10 are net-shaped supports formed by combining a plurality of rhombic grid-shaped units. The body support 11 is a cylindrical support structure.

The atrium disk 12 is a disk-like structure extending towards the periphery of the atrium end of the body support, is connected with the body support 11, and is used for fixing the atrium side of the valve support and preventing paravalvular leakage.

The connecting element 13 is a structure of a plurality of atrium side protrusions connected to the atrium side of the body frame and is used for being detachably connected with the conveying system.

Further, the connecting member 13 has a circular, oval or ear-shaped structure.

The valve stent 10 is made of memory alloy and has shape memory and self-expansion properties; the valve stent 10 can be compressed into a delivery catheter outside the body and expanded to restore the working state after being in the body.

Further, the valve stent 10 is integrally formed by laser cutting.

Artificial valve

The artificial valve leaflet 20 is an artificial valve sewn in the cavity of the body support 11, is a three-leaflet valve and is made of bovine pericardium, porcine pericardium or high polymer materials.

Anchoring member

The anchoring members 30 are a plurality of terminal blunt structures attached to the opposite side of the body frame 11 toward the atrium.

The anchoring member 30 has a structure in which one end is a blunt free end and the other end is connected to the ventricular side of the body frame 11 and is folded back toward the ventricular side, and the whole anchoring member is in a cord shape, a triangular shape, a lug shape, an S shape or an oval shape, and the number of the anchoring members is 2-6, preferably 3.

The free ends of the anchoring elements 30 are designed close to the atrial disc surface 12 in the axial direction of the body support 11 and close to the body support 11 in the radial cross section of the body support 11, thereby preventing the artificial valve from being implanted too high towards the atrial side.

Further, the anchor 30 has a shape memory property, and is made of a shape memory metal; in the delivery state, the anchoring member 30 is pulled to the ventricular side direction and is axially connected in series with the body support, so that the size of the delivery conduit is reduced; after release, the working state can restore the memory shape, and the memory shape is reversely folded towards the atrial side and is close to the atrial disc surface 12 and the body support 11.

In one embodiment, the anchor 30 and the body support 11 are separate structures that are physically connected to each other.

Fixing ring

The fixed ring 40 is a circular ring-shaped one-turn (fig. 4-7, and 9) or multi-turn ring-shaped structure (fig. 10-11);

the fixing ring 40 is made of metal or high polymer material, is of an open-loop structure outside the body, is conveyed through a catheter after being straightened, and becomes an annular structure after being released after being conveyed into the body. And the fixation ring 40 is radiographically active so that it can be seen by an X-ray machine during surgery.

One embodiment, a ring of retaining rings 40, in an open loop configuration, see fig. 4-7, includes a ring body 41 and a retaining ring head 42 at the end of the ring body 41. The ring body 41 is made of metal or polymer material, and is a solid ring or a braided ring of an elastic ring.

In another embodiment, referring to fig. 9, the fixed ring 40 is a closed loop structure of one turn, including only the ring body 41, which itself is also an elastic ring.

In another embodiment, a multi-turn fixing ring 40, see fig. 10 and 11, adopts an open-loop structure, and the ring body 41 is a multi-turn spiral ring body, and has a positioning tail end 43 with a positioning head 42 at one end and a smooth ball head at the other end.

The chordae tendineae under each leaflet are drawn together from the periphery to the center by being implanted under the atrioventricular valve from the apex of the heart or transvascularly, coiled around the chordae tendineae plexus of the mitral or tricuspid valve.

Film coating

Further, the system also comprises a covering film which is made of a biocompatible polymer material and covers the periphery of the body support 11 and the atrial disc surface 12 to prevent paravalvular leakage.

The covering film is made of polymer materials such as PET and the like, and covers the periphery of the body support and the atrial disc surface to prevent perivalvular leakage.

Principle of operation (see 12a-12d of FIG. 12): firstly, an interventional method is adopted, a fixing ring is conveyed to the lower part of an atrioventricular valve through a catheter, so that the fixing ring is wound around a mitral valve or tricuspid valve chordae tendineae, and the chordae tendineae under each valve leaf are drawn together from the periphery to the center; delivering the artificial valve to the ventricle through the venous system and the catheter, withdrawing the delivery sheath and opening the anchoring piece; hooking the fixing ring by the anchoring piece, and pulling the fixing ring and the artificial valve to the atrium side together; releasing the atrial disc surface of the artificial valve to be attached to the atrial surface of the atrioventricular valve; fifthly, the fixing parts of the conveying system and the artificial valve are unhooked, the artificial valve is completely released, and the conveying system is retracted.

In conclusion, the system and the method have the advantages that the valve leaflets are close by drawing the chordae tendineae under the valve through the pre-implanted fixing ring, so that the risk of obstruction of the outflow tract of the left ventricle can be avoided, the size of the implanted artificial valve system is reduced, the whole valve stent can be implanted through veins, and the wound is smaller; the artificial valve adopts a large barb fixing element, so that the fixation is firm, meanwhile, the fixing element is released to hook the fixing ring firstly, and then the whole valve is released, so that the valve releasing process is simple.

Finally, it should be noted that: the above examples are only intended to illustrate the technical solution of the present invention, but not to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; and such modifications or substitutions do not depart from the spirit and scope of the corresponding technical solutions of the embodiments of the present invention.