Aortic valve prosthesis for treating aortic valve failure

Abstract

The application relates to the field of medical devices, in particular to a valve prosthesis for treating a main aorta, which comprises an expandable stent for supporting and anchoring, a positioning mechanism for positioning and clamping autologous valve leaflets, the expandable stent has an inflow end and an outflow end, the positioning mechanism is fixed at the outflow end of the expandable stent through a wire or a silk, the positioning mechanism comprises a ring-shaped main body and a connecting member, a plurality of peaks are formed at the top end of the ring-shaped main body, and the ring-shaped main body comprises a first end portion and a second end portion, the first end portion and the second end portion are fixedly connected through cooperation of the connecting member; in the application, the first end portion and the second end portion of the ring-shaped main body are butted and fixed through the connecting member, the stability and the connecting strength of the two end portions can be guaranteed, and the opening angles between adjacent positioning portions (the ring-shaped main body is located at the bottom part of the aortic sinus) and the clamping strength are consistent.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to a valve prosthesis for treating aorta. Background Art

[0002] At present, aortic valve stents mainly include mechanically expandable stents, balloon-expandable stents, and self-expanding stents. After the release of mechanically expandable stents and balloon-expandable stents, the open area of ​​the valve is small, and precise positioning is impossible, and the transvalvular pressure difference is large. Although the transvalvular pressure difference and conduction block are small after the release of the self-expanding stent, the coaxiality after release is poor, and precise positioning is impossible, which can easily cause problems such as paravalvular leakage and valve slippage. Currently, most aortic valve stents are designed for patients with aortic valve stenosis. For patients with aortic valve regurgitation, positioning mechanisms are often used to assist in positioning and anchoring, thereby improving and preventing aortic valve regurgitation. However, when capturing the leaflets, the positioning mechanism usually brings certain difficulties to the operator in operation due to insufficient opening angle and inconsistent opening angle, and the positioning mechanism also causes damage to the valve tissue.

[0003] Patent CN202221406688.X discloses an artificial valve ring and its delivery system, the artificial valve ring includes a ring body, the ring body is elastic, a first adjustment body and a second adjustment body are formed on the ring body, a first adjustment surface is formed on the first adjustment body, a second adjustment surface is formed on the second adjustment body, the distance between the first adjustment surface and the second adjustment surface at the first end is smaller than the distance between the first adjustment surface and the second adjustment surface at the second end, an adjustment member is provided on the ring body, and the adjustment member slides with the first adjustment surface and the second adjustment surface. In this solution, the first adjustment surface and the second adjustment surface are provided with teeth, which shows that the diameter of the ring body is large, and accordingly, the rigidity of the ring body is also large. After implantation, the adaptability of the ring body is poor and cannot conform to the shape of the aortic valve. At the same time, there is a high probability that the ring body will have a sharp cutting angle after cutting, which is easy to cause damage to the aortic valve tissue.

[0004] In summary, the problems that urgently need to be solved in this field include: 1. The existing positioning mechanism is made of pipe cutting, but the pipe cutting is very rigid, which makes it difficult to adapt to the valve tissue morphology, and the cutting is prone to sharp angles causing tissue damage; 2. If the positioning mechanism is made of raw wire, then how to connect the two ends of the raw wire will become the main problem. For example, if welding is used, the toughness of the connection is not enough, which may cause breakage. If the two ends of the raw wire are connected by a flexible wire, the two ends of the raw wire must partially overlap to ensure the stability of the connection. However, the overlap of the two ends will cause the opening angle of the positioning mechanism to be inconsistent, and the clamping force of adjacent positioning parts will also be inconsistent, affecting its effect in treating reflux. Summary of the Invention

[0005] In view of the above and other concepts, this application is proposed. The main purpose of this application is to overcome some problems and shortcomings of the prior art.

[0006] According to one aspect of the present application, a valve prosthesis for treating the aorta is provided, comprising: an expandable stent for support and anchoring, a positioning mechanism for positioning and clamping the autologous valve leaflet, the expandable stent having an inflow end and an outflow end, the positioning mechanism being fixed to the outflow end of the expandable stent by a wire or a thread, the positioning mechanism comprising an annular body and a connecting member, the top of the annular body being formed with a plurality of peaks, and the annular body comprising a first end and a second end, the first end and the second end being fixedly connected by cooperation of the connecting member.

[0007] According to an embodiment, the connecting member is a rigid member.

[0008] According to one embodiment, the peaks are evenly distributed along the circumference of the expandable stent, and the first end portion and the second end portion are butted against each other to form one of the peaks.

[0009] According to one embodiment, the positioning mechanism further includes a first sleeve and a second sleeve provided on the annular body, and the first sleeve and the second sleeve are respectively close to the first end and the second end.

[0010] According to one embodiment, the connecting member is arranged in a "U" structure, and, during pre-assembly, both ends of the connecting member are inserted into the first sleeve and the second sleeve respectively.

[0011] According to one embodiment, the positioning mechanism further includes a wire or a thread for binding the connecting member and the annular body.

[0012] According to one embodiment, the annular body is made of a braided wire made of memory metal, and the cross section of the annular body is circular.

[0013] According to one embodiment, the annular body is elastic, and when the positioning mechanism is transported to the target surgical site, the annular body can deform according to the tissue morphology.

[0014] According to one embodiment, U-shaped valleys are formed between adjacent peaks of the annular body.

[0015] According to one embodiment, the U-shaped trough is in close contact with the outside of the expandable stent in a natural state.

[0016] According to one embodiment, after the positioning mechanism captures the autologous leaflet, the inflow end of the expandable stent is released so that the autologous leaflet is clamped between the positioning mechanism and the expandable stent, and then the outflow end of the expandable stent is released to complete the implantation of the valve prosthesis.

[0017] Compared with the prior art, the advantages and beneficial technical effects of this application include at least the following:

[0018] 1. Most existing positioning mechanisms are made by cutting metal pipes with larger diameters. However, the larger diameter will cause the positioning mechanism to be too rigid and unable to conform to the shape of the tissue inside the valve. In addition, the cut pipe will produce sharp surfaces, which can easily damage the tissue. If the two ends of the positioning mechanism are made of round wire and fixed by welding, they are prone to breakage. If they are fixed by binding wire, the ends must partially overlap to ensure the stability of the connection. However, the overlap of the two ends will lead to inconsistent opening angles of the positioning mechanism and inconsistent clamping forces of adjacent positioning parts, affecting its effect in treating reflux. Different from the existing technology, in one embodiment of the present application, the first end and the second end of the annular body are butt-jointed, and the two ends are fixed by a connecting member, which can not only ensure the stability and strength of the connection, but also ensure that the opening angles and clamping forces between adjacent positioning parts (the annular body is located at the bottom of the aortic sinus) are consistent.

[0019] 2. Different from the prior art, the connecting member in one embodiment of the present application is a rigid member, and the two ends of the connecting member are respectively inserted into the first sleeve and the second sleeve to complete pre-installation, which is not only simple and efficient to assemble, but also can ensure the stability and strength of the connection.

[0020] 3. Different from the prior art, in one embodiment of the present application, the cross-section of the annular body is circular, and the ends of the annular body are fixed by connecting components, which effectively prevents the positioning mechanism from causing scratches and damage to the tissue after implantation. At the same time, the annular body has elasticity, so that it can deform according to the tissue morphology.

[0021] The embodiments of the present application can achieve other beneficial technical effects that are not listed one by one. These other technical effects may be partially described below and can be anticipated and understood by those skilled in the art after reading this application. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The above features and advantages of these embodiments and other features and advantages and the manner in which they are achieved will become more apparent, and the embodiments of the present application may be better understood, by referring to the following description taken in conjunction with the accompanying drawings, in which:

[0023] Figure 1 It is a schematic structural diagram of the valve prosthesis of the present invention.

[0024] Figures 2a to 2c Structure diagram of positioning mechanism of the present application.

[0025] Figures 3a to 3c Process diagram of valve prosthesis implantation of the present application.

[0026] The parts referred to by the numbers in the drawings are as follows: 1 - expandable stent, 11 - inflow end, 12 - outflow end, 2 - positioning mechanism, 21 - annular body, 211 - first end portion, 212 - second end portion, 213 - peak, 22 - connecting member, 23 - first sleeve, 24 - second sleeve, 25 - wire. Embodiments

[0027] The details of one or more embodiments of the application are set forth in the accompanying description below. Other features, objects, and advantages of the application will be apparent from the description and drawings, and from the claims.

[0028] It should be understood that the illustrated and described embodiments are not limited in application to the details of construction and arrangement of parts illustrated in the following description or illustrated in the drawings. The illustrated embodiments can be one of many embodiments and can be practiced or carried out in various ways. Examples are provided by way of explanation of the disclosed embodiments but are not intended to be limiting. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made in the embodiments of the present application without departing from the scope or spirit of the application. For example, features illustrated or described as part of one embodiment, can be used with another embodiment to yield a still further embodiment. Thus, it is intended that the present application cover modifications and variations of this application provided they come within the scope of the appended claims and their equivalents.

[0029] Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and not of limitation. The use of terms such as "including," "comprising," or "having" and variations thereof herein is intended to be open-ended, and includes the inclusion of items listed thereafter and equivalents thereof, as well as possible additional items.

[0030] As Figure 1As shown, a valve prosthesis for treating aorta includes an expandable stent 1 for supporting and anchoring, and a positioning mechanism 2 for positioning and clamping autologous valve leaflets. The expandable stent 1 has an inflow end 11 and an outflow end 12. The positioning mechanism 2 is fixed to the outflow end 12 of the expandable stent 1 by a wire or a thread. The positioning mechanism 2 includes an annular body 21 and a connecting member 22. The annular body 21 includes a first end 211 and a second end 212. The first end 211 and the second end 212 are connected to each other and cooperate with the connecting member 22 to achieve a fixed connection between the two ends. Figure 2b and 2c As shown, such a connection method not only ensures the connection stability and strength between the two ends, but also ensures that the adjacent positioning parts (the annular main body is located at the bottom of the aortic sinus) have consistent opening angles when clamping the leaflets and consistent clamping forces after clamping the leaflets.

[0031] According to one embodiment, the top of the annular body 21 is formed with a plurality of peaks, one of which is formed by the connection between the first end 211 and the second end 212, and the peaks 213 are evenly distributed along the circumference of the expandable stent. Figure 2a and 2b shown.

[0032] According to one embodiment, a "U"-shaped trough is formed between adjacent peaks of the annular body 21. The "U"-shaped trough is tightly attached to the outer side of the expandable stent in a natural state. After the valve prosthesis is implanted in the body, it can better fit the autologous leaflet and improve the clamping force of the positioning mechanism on the autologous leaflet.

[0033] According to one embodiment, the connecting member 22 is a rigid member and is arranged in a "U" structure. The positioning mechanism 2 further includes a first sleeve 23 and a second sleeve 24 provided on the annular body. The first sleeve 23 and the second sleeve 24 are respectively close to the first end 211 and the second end 212. When pre-assembled, the two ends of the connecting member 22 are respectively inserted into the first sleeve 23 and the second sleeve 24. Figure 2b and 2c shown.

[0034] According to one embodiment, the positioning mechanism 2 further includes a wire 25, which is used to bind the connecting member 22 and the annular body 21, so that the connection between the connecting member 21 and the annular body 21 is more secure. Figure 2a shown.

[0035] According to one embodiment, the annular body 21 is made of a braided wire made of memory metal, and the annular body 21 is elastic and has a circular cross-section. When the positioning mechanism 2 is delivered to the target surgical position, the annular body 21 can deform according to the morphology of the autologous leaflet, thereby increasing the holding force of the positioning mechanism 2 and effectively preventing the positioning mechanism 2 from scratching and damaging the tissue during and after implantation.

[0036] According to one embodiment, after the positioning mechanism 2 captures the native leaflet, the inflow end of the expandable stent 1 is released, so that the native leaflet is clamped between the positioning mechanism 2 and the expandable stent 1, and then the outflow end of the expandable stent 1 is released to complete the implantation of the valve prosthesis. Figures 3a to 3c shown.

[0037] The foregoing description of exemplary embodiments of the present application has been presented for purposes of illustration. It is not intended to be exhaustive or to limit the present application to the precise configurations and / or constructions disclosed, and it is apparent that numerous modifications and variations may be made by those skilled in the art in light of the above teachings without departing from the present invention. It is intended that the scope and full range of equivalents of the present invention be defined by the claims appended hereto.

Claims

1. A valve prosthesis for treating aortic valve failure, comprising an expandable stent for supporting and anchoring the valve, and a positioning mechanism for positioning and clamping the native valve leaflet, wherein the expandable stent has an inflow end and an outflow end, and the positioning mechanism is fixed to the outflow end of the expandable stent by a wire or a thread, characterized in that: The positioning mechanism includes an annular body and a connecting member, the top of the annular body is formed with multiple peaks, and the annular body includes a first end and a second end, and the first end and the second end are fixedly connected by the connecting member; the first end and the second end of the annular body are butt-jointed, and the two ends are fixed by the connecting member, and the positioning mechanism also includes a first sleeve and a second sleeve arranged on the annular body, and the first sleeve and the second sleeve are respectively close to the first end and the second end, and when pre-installed, the two ends of the connecting member are respectively inserted into the first sleeve and the second sleeve.

2. The valve prosthesis for treating aorta according to claim 1, characterized in that: The connecting member is a rigid member.

3. The valve prosthesis for treating aorta according to claim 1, characterized in that: The peaks are evenly distributed along the circumference of the expandable stent, and the first end portion is butted against the second end portion to form one of the peaks.

4. The valve prosthesis for treating aorta according to claim 1, characterized in that: The connecting member is arranged in a "U" structure, and, during pre-assembly, both ends of the connecting member are respectively inserted into the first sleeve and the second sleeve.

5. The valve prosthesis for treating aorta according to claim 1, characterized in that: The positioning mechanism further includes a wire or a thread for binding the connecting member and the annular body.

6. The valve prosthesis for treating aorta according to claim 1, characterized in that: The annular body is made of braided wire made of memory metal, and the cross section of the annular body is circular.

7. The valve prosthesis for treating aorta according to claim 1, characterized in that: The annular body is elastic, and when the positioning mechanism is transported to the target surgical position, the annular body can deform according to the tissue morphology.

8. The valve prosthesis for treating aorta according to claim 1, characterized in that: A U-shaped valley is formed between adjacent peaks of the annular body.

9. The valve prosthesis for treating aorta according to claim 8, characterized in that: The "U"-shaped trough is in close contact with the outer side of the expandable stent in a natural state.

10. The valve prosthesis for treating aorta according to claim 1, characterized in that: After the positioning mechanism captures the autologous leaflet, the inflow end of the expandable stent is released, so that the autologous leaflet is clamped between the positioning mechanism and the expandable stent, and then the outflow end of the expandable stent is released to complete the implantation of the valve prosthesis.

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