WO2017121192A1

WO2017121192A1 - Apparatus, having spinous positioning rods, for transcatheter delivery of aortic valve

Info

Publication number: WO2017121192A1
Application number: PCT/CN2016/107221
Authority: WO
Inventors: 周庆亮; 代高旭; 孟坚; 可大年; 史欢欢; 李阳; 黄韬; 杨宇霆
Original assignee: 北京迈迪顶峰医疗科技有限公司
Priority date: 2016-01-11
Filing date: 2016-11-25
Publication date: 2017-07-20
Also published as: CN105496608A

Abstract

Provided is an apparatus (100), having spinous positioning rods, for transcatheter delivery of an aortic valve, said aortic valve apparatus (100) comprising: a support frame; valve leaflets (104) fixed to the inner side of the middle part of said support frame; and a skirt (102) fixed along the periphery of the inner side of said support frame and fixed to said valve leaflets (104); a three-leaf upper flared opening structure (105) is formed by the upper end of the support frame; at the end of said upper flared opening structure (105) are three circular connecting claws (106) used for mounting the support frame; exposed spinous positioning rods (103) extending in the direction of the bottom end of the support frame are provided on the outer side of the middle part of the support frame; the bottom end of the support frame is provided with an outwardly dilating lower flared opening structure (101) used for reducing perivalvular leakage.

Description

Transcatheter delivery aortic valve device with thorn-shaped positioning rod

Technical field

The present invention relates to the field of medical devices, and more particularly to a transcatheter-delivered aortic valve device having a thorn-shaped positioning rod.

Background technique

With the aging of the population, valvular disease caused by senile valvular disease and coronary heart disease and myocardial infarction is also becoming more and more common. Surgical treatment, such as prosthetic heart valve replacement or valvuloplasty, is the cure for valvular heart disease. However, for some patients with advanced age, multiple comorbidities, or history of surgical thoracotomy, the mortality rate of surgical thoracotomy is very high. high. In recent years, with the advancement of interventional techniques, the epoch-making technique of transcatheter prosthetic valves has pushed interventional surgery to the peak of technology and tried to solve all the deficiencies of surgical valve replacement. In 2002, the success of the first transcatheter prosthetic valve replacement surgery marked the beginning of this revolutionary interventional medical technology into a feasible stage. After 10 years of development, more than 100,000 people have rebuilt heart function through this technology. Get a new life.

However, the existing aortic valve device may be released for recovery; or the positioning may be accurate but not recyclable; or the release may be released and the positioning is accurate, but the indication is limited.

Summary of the invention

It is an object of the present invention to provide a transcatheter-delivered aortic valve device having a thorn-shaped positioning rod for implantation into an in situ aortic valve resulting from a lesion of the aortic stenosis or regurgitation, Solve the problem that the aortic valve device is positioned accurately and cannot be recovered once released; further, to solve problems that adapt to various diseases, such as severely calcified aortic stenosis, separate aorta Stenosis or regurgitation and two-valve problems.

The present invention provides a transcatheter-delivered aortic valve device having a lancet-shaped positioning rod, the aortic valve device comprising: a support frame; a leaflet fixed to an inner side of the intermediate portion of the support frame; a skirt fixed to the inner side of the support frame and fixed to the leaflet; wherein an upper end of the support frame forms an upper bell mouth structure in the form of a three-lobed; at the end of the upper bell mouth structure, there is a support frame for the support frame Loading three circular connecting claws; an outer side of the intermediate portion of the supporting frame has an exposed thorn-shaped positioning rod extending toward a bottom end of the supporting frame; a bottom end of the supporting frame is provided for reducing a flap The outer flared lower bell structure of the leak.

Optionally, the material of the support frame is a memory alloy, such as a nickel-titanium alloy material; the middle portion is a vertical segment, and the lower bell mouth structure has a degree of opening that is smaller than a degree of opening of the upper bell mouth structure.

Optionally, the support frame is a mesh structure composed of a diamond-shaped mesh unit; and an inclination of an end of the upper bell mouth structure and the lower bell mouth structure from the central axis of the support frame is 1° to 15°.

Alternatively, the center of the circular connecting claw is a circular or square through hole or a non-porous shape, and the circular connecting claw and the upper bell mouth structure are connected by a short link.

Alternatively, the root position of the thorn-shaped positioning rod is 10 mm to 25 mm from the bottom end of the support frame.

Alternatively, the thorn-shaped positioning rods are evenly distributed along the circumference of the support frame in an amount of 3 to 12.

Alternatively, the thorn-shaped positioning rod has a length of 4 mm to 15 mm; the thorn-shaped positioning rod has a width of 0.3 mm to 1 mm.

Optionally, the circumferential diameter of the circumscribed circle of the thorn-shaped positioning rod is larger than the vertical section of the intermediate portion of the support frame by a diameter of 3 mm to 9 mm.

Alternatively, the thorn-shaped positioning rod and the support frame may be a one-piece structure or a separate structure, the integrated structure is laser-cut, and the separate structure is laser welded.

Optionally, the expanded lower bellows structure at the bottom end of the support frame has a height of 3 mm to 8 mm and a diameter greater than 3 mm to 6 mm of the vertical portion of the intermediate portion of the support frame.

Alternatively, the intermediate portion of the support frame and the upper bell structure of the support frame are connected to each other by a short link.

Alternatively, the short link has a length of 1.5 mm to 4 mm and a width of 0.25 mm to 1 mm.

Optionally, adjacent ones of the grid cells of the support frame are connected by short and left concave links.

Alternatively, the left and right concave short links have a minimum width of 0.25 mm to 0.5 mm.

Alternatively, the left and right concave short links are a concave structure formed by two left and right semicircles or a concave structure formed by a short straight line and left and right circular arcs.

Optionally, the material of the leaflet is a pig pericardium, a bovine pericardium, a horse pericardium or a polymer material polytetrafluoroethylene.

Optionally, the material of the skirt is pig pericard, burdock, horse heart bag, polymer material polytetrafluoroethylene or polyester cloth.

Advantages of the present invention include loading and recycling of the aortic valve device by providing a flared structure at the upper end of the aortic valve support frame and three circular connecting claws at the end of the bell mouth structure; Partially downwardly exposed thorn-shaped positioning rods enable precise positioning of the aortic valve device, making the surgical procedure safer and more reliable.

DRAWINGS

Figure 1 is a schematic illustration of an aortic valve device of the present invention;

Figure 2 is a plan view of an aortic valve device of the present invention;

Figure 3 is a developed perspective view of an aortic valve device of the present invention;

4 is a schematic exploded view of a lancet positioning rod of an aortic valve device of the present invention;

Figure 5 is a schematic illustration of the loading of the aortic valve device of the present invention into a delivery system;

Figure 6 is a schematic view showing the release of the lancet positioning rod of the aortic valve device of the present invention;

Figure 7 is a schematic view showing the release of the lancet positioning rod and the bottom end of the support frame of the aortic valve device of the present invention;

Figure 8 is a schematic view showing the complete release of the aortic valve device of the present invention;

Figure 9 is a schematic view showing the positioning of the aortic valve device of the present invention at the heart position;

Figure 10 is a schematic view showing the positioning of the aortic valve device of the present invention at the heart position of the stab-shaped positioning rod and the bottom end of the stent;

Figure 11 is a schematic illustration of the complete release of the aortic valve device of the present invention at the heart position.

detailed description

The transcatheter-delivered aortic valve device with a thorn-shaped positioning rod is used for implantation into an in situ aortic valve caused by aortic stenosis or regurgitation to resolve the aortic valve The device is positioned accurately and cannot be recovered once released; it also attempts to address problems that are commensurate with a variety of conditions, such as severely calcified aortic stenosis, aortic stenosis or regurgitation alone, and two-valve problems.

The embodiments of the present invention are described in detail below with reference to the accompanying drawings.

An aortic valve device 100 as shown in Figures 1 to 4 for implantation into aortic valve An in situ aortic valve that causes a lesion to be narrowed or closed, comprising: a support frame, a leaflet 104 fixed to an inner side of the intermediate portion of the support frame, and fixed along the inner periphery of the support frame, and the leaflet Fixed skirt 102. Further, the skirt 102 is formed in a circle around the support frame, and is fixed by suture stitching; the leaflets 104 are three pieces (please refer to FIG. 2), are sewn to the middle portion of the support frame, and are fixedly stitched with the skirt 102.

The support frame includes an upper bell mouth structure 105 formed in an upper end of the support frame in the form of three flaps, and three circular connecting claws 106 for loading the support frame at the end of the upper bell mouth structure An intermediate portion of the support frame having an exposed spine-shaped positioning rod 103 extending toward a bottom end of the support frame at an outer side thereof; and an outward expansion of the bottom end of the support frame for reducing leakage of the valve Lower bell mouth structure 101. (Please refer to Figure 1).

The material of the support frame may be a memory alloy such as a nickel titanium alloy material.

The middle portion is a vertical section, and the opening of the lower bell mouth structure 101 is smaller than the opening degree of the upper bell mouth structure 105.

The support frame is a mesh structure formed by a diamond-shaped mesh unit; adjacent ones of the mesh units of the support frame are connected by short and left concave ends. Alternatively, the left and right concave short links have a minimum width of 0.25 mm to 0.5 mm. Alternatively, the left and right concave short links are a concave structure formed by two left and right semicircles or a concave structure formed by a short straight line and left and right circular arcs.

The inclination of the end of the upper bell mouth structure and the lower bell mouth structure from the central axis of the support frame is 1 to 15 degrees, respectively. The lower bell mouth structure 101 and the intermediate portion of the support frame smoothly transition; the middle portion of the support frame and the upper bell mouth structure 105 smoothly transition; the middle portion of the support frame and the upper bell mouth structure 105 are connected by the short link 107 (refer to FIG. 4) The short link has a length of 1.5 mm to 4 mm and a width of 0.25 mm to 1 mm. Short between the diamond-shaped grid elements of the support frame The connecting rod 108 is connected (please refer to FIG. 4); the middle portion of the upper bell mouth structure 105 is flared, and the upper bell mouth structure 105 is evenly distributed around the supporting frame; the circular connecting claw 106 and the upper bell mouth structure 105 are connected by a short connecting rod. The circular connecting claw 106 is a hollow or solid structure. Further, the center of the circular connecting claw 106 is a circular or square through hole or a non-porous shape.

The thorn-shaped positioning rod 103 is located at an intermediate portion of the support frame, and is circumferentially evenly distributed in the middle portion of the support frame, and the direction of the thorn is directed to the lower bell mouth structure 101 of the support frame; the root position of the thorn-shaped positioning rod is at the bottom of the support frame The end distance is 10mm to 25mm. The thorn-shaped positioning rods are evenly distributed along the circumference of the support frame, and the number is from 3 to 12. Alternatively, the thorn-shaped positioning rod has a length of 4 mm to 15 mm; the thorn-shaped positioning rod has a width of 0.3 mm to 1 mm. The circumferential diameter of the circumscribed circle of the thorn-shaped positioning rod is larger than the diameter of the vertical portion of the intermediate portion of the support frame by 3 mm to 9 mm. The thorn-shaped positioning rod and the support frame may be an integral structure or a separate structure, the integrated structure is formed by laser cutting, and the separated structure is formed by laser welding.

The height of the lower bell mouth structure is 3 mm to 8 mm, and the diameter of the circumscribed circle is larger than the vertical section of the middle portion of the support frame by 3 mm to 6 mm.

The material of the leaflet and the material of the skirt may be pig pericardium, bovine pericardium, horse pericardium or polymer material polytetrafluoroethylene.

The aortic valve device is loaded and recovered by providing a bell mouth structure at the upper end of the aortic valve support frame and three circular connecting claws at the end of the bell mouth structure; the middle portion of the support frame is exposed downward. The thorn-shaped positioning rod realizes the precise positioning of the aortic valve device, making the surgical procedure more safe and reliable.

The working process of a transcatheter delivery aortic valve device with a thorn-shaped positioning rod according to an embodiment of the present invention is as follows:

The aortic valve device 100 is first loaded into the head end 201 of the delivery system 200 and the loading sheath 202 by a certain device (see FIG. 5), and the loading sheath 202 of the delivery system 200 is moved backward by the handle 203. The lancet positioning rod 103 of the aortic valve device 100 is released (please refer to FIG. 6 and FIG. 9). At this time, due to the characteristics of the memory alloy of the aortic valve device 100 itself, the thorn positioning The rod 103 automatically expands and slowly pushes the delivery system 200 downward so that the stab-shaped positioning rod 103 contacts the human natural leaflet tissue 300, stopping the push delivery system 200. The head end 201 of the delivery system 200 is then moved forward by the handle 203 such that the lower bell structure 101 of the aortic valve device 100 is released from the head end 201 of the delivery system 200 due to the aortic valve device The characteristics of the material itself's memory alloy, the lower bell mouth structure 101 is automatically inflated (please refer to FIG. 7), and the human natural leaflet tissue 300 is opened. At this time, the human natural leaflet tissue 300 is in the aortic valve device 100. Between the lower bell mouth structure 101 and the lancet positioning rod 103 (please refer to FIG. 10), the aortic valve device 100 performs precise positioning. The loading sheath 202 is again moved back through the handle 203 of the delivery system 200, releasing the upper flare structure 105 and the circular connecting jaw 106 of the aortic valve device 100 from the loading sheath 202 (refer to Figure 8). The upper bell mouth structure 105 automatically expands to a maximum due to the nature of the material of the aortic valve device 100, and is fixed to the vessel wall (please refer to FIG. 11), and finally the delivery system 200 and the circle The connecting jaws 106 are disengaged and the delivery system 200 is withdrawn, and the aortic valve device 100 is implanted.

The above embodiments are merely illustrative of the present invention and are not intended to be limiting of the invention, and various modifications and changes can be made without departing from the spirit and scope of the invention. Equivalent technical solutions are also within the scope of the invention, and the scope of the invention is defined by the claims.

Claims

A transcatheter delivery aortic valve device having a thorn-shaped positioning rod, the aortic valve device comprising: a support frame; a leaflet fixed to an inner side of the intermediate portion of the support frame; and an inner periphery of the support frame a skirt fixed to and fixed to the leaflet; characterized in that: the upper end of the support frame forms an upper bell mouth structure in the form of three lobes; at the end of the upper bell mouth structure there is a loading for the support frame Three circular connecting claws; an outer side of the middle portion of the supporting frame has an exposed thorn-shaped positioning rod extending toward a bottom end of the supporting frame; and a bottom end of the supporting frame is provided for reducing a valve leakage The outwardly flared lower bell structure.
The aortic valve device according to claim 1, wherein the support frame is a Nitinol material; the intermediate portion is a vertical section, and the lower bell mouth structure has a smaller opening than the upper bell mouth. The degree of opening of the structure.
The aortic valve device according to claim 1, wherein the support frame is a mesh structure composed of a diamond-shaped mesh unit; and an end of the upper bell structure and the lower bell structure is deviated The inclination angle of the central axis of the support frame is 1° to 15°, respectively.
The aortic valve device according to claim 1, wherein the center of the circular connecting claw is a circular or square through hole or a non-porous shape, and the circular connecting claw and the upper bell mouth structure are short. Connecting rods.
The aortic valve device according to claim 1, wherein the thorn-shaped positioning rod and the support frame are of a unitary structure or a structure joined by welding.
The aortic valve device according to claim 1, wherein the intermediate portion of the support frame and the upper bell structure of the support frame are connected to each other by a short link.
The aortic valve device of claim 3, wherein: said support frame The adjacent grid units of the rack are connected by short and left concave links.
The aortic valve device according to claim 7, wherein the left and right concave short links are concave structures formed by two left and right circular arcs or a small straight segment formed by left and right circular arcs. structure.
The aortic valve device according to claim 1, wherein the material of the leaflet is a pig pericardium, a bovine pericardium, a horse pericardium or a polymer material polytetrafluoroethylene.
The aortic valve device according to claim 1, wherein the material of the skirt is a pig pericardium, a bovine pericardium, a horse pericardium, a polymer material polytetrafluoroethylene or a polyester cloth.