Prosthesis capable of treating valve regurgitation and release method

Abstract

The invention relates to the field of medical instruments, in particular to a prosthesis capable of treating valve regurgitation, which comprises a stent main body capable of expanding in the radial direction, the stent main body comprises a plurality of rhombic grids and at least three clamping pieces arranged at the outflow end of the stent main body, and the clamping pieces are used for positioning aortic sinus and clamping autologous valve leaflets; a sealing bag bulging outwards is arranged on the stent body between the adjacent clamping pieces, the position of the sealing bag corresponds to the junction area of the aortic valve leaflet, the sealing bag is attached to the tissue of the junction area of the aortic valve leaflet, and the structure of the sealing bag is configured in a way that when blood regurgitates, the sealing bag can seal the tissue of the junction area of the aortic valve leaflet. The regurgitated blood is guided to be shunted to the two sides into the adjacent aortic sinus; the sealing bag enables backflow blood to flow into the adjacent aortic sinus in a guiding and shunting mode, backflow of the blood is avoided, meanwhile, when blood is pumped next time on the aorta, the blood in the aortic sinus is ejected out, and thrombus caused by blood deposition is avoided.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, and in particular to a prosthesis for treating valve regurgitation and a releasing method. BACKGROUND

[0002] With the continuous extension of the average life expectancy and the increasingly serious global population aging trend, the incidence of heart valve disease shows a significant increasing trend. Among the elderly patients, the incidence of heart valve disease ranks third, only next to hypertension and coronary heart disease, with an incidence of 13.3%.

[0003] Heart valve disease includes aortic valve disease, mitral valve disease, tricuspid valve disease, and pulmonary valve disease. Among them, aortic valve disease includes aortic valve stenosis and aortic valve regurgitation. Aortic valve stenosis is mainly caused by calcification of the valve leaflet, which leads to a decrease in the opening area of the valve leaflet, so that the blood in the left ventricle cannot flow to the aorta sufficiently, resulting in an increase in the intraventricular pressure. Aortic valve regurgitation is mainly in diastole, and the valve leaflet cannot close completely, which leads to the blood flowing to the aorta backflowing to the left ventricle, resulting in an increase in the intraventricular pressure.

[0004] In recent years, due to the advantages of small trauma and rapid recovery, transcatheter aortic valve replacement has gradually become a replacement method for surgical operation and is applied to the treatment of aortic valve disease. Most of the aortic prostheses on the market are aimed at aortic stenosis, and there are fewer choices for aortic regurgitation. In the long-term postoperative observation, it is found that after the implantation of the aortic prosthesis, there is still regurgitation at the junction of the valve leaflet, and after long-term implantation, complications such as thrombosis may occur.

[0005] In the patent CN202211080434.8, an aortic prosthesis capable of preventing regurgitation at the junction is disclosed, which comprises a stent for support and anchoring, a positioning member for positioning and clamping the native valve leaflet, and a leak-proof mechanism, the stent comprises a plurality of inflatable rhombic meshes, the leak-proof mechanism comprises a sealing membrane and a support rod, one end of the support rod is connected to the rhombic mesh between adjacent positioning members and extends downward to form a filling part protruding outward of the stent, the other end of the support rod is free, and the sealing membrane is connected with the rhombic mesh; wherein, after the aortic prosthesis is installed in place, the filling part is located at the junction of the native valve leaflet and abuts against the blood vessel tissue, so that the filling part drives the other end of the support rod to be raised outward of the stent with the connecting point of the support rod and the rhombic mesh as the fulcrum, and the sealing membrane expands with the support rod and forms an anti-regurgitation pocket to prevent blood regurgitation. The patent scheme also proposes the problem of regurgitation at the junction, and uses an anti-regurgitation pocket to contain the blood regurgitated at the junction, but the anti-regurgitation pocket is directed towards the ascending aorta, if the amount of regurgitated blood is large, the anti-regurgitation pocket cannot completely contain the regurgitated blood, resulting in part of the blood still regurgitating into the left ventricle. And part of the blood in the anti-regurgitation pocket may not be discharged, which may cause thrombosis in the pocket over a long period of time, endangering the health of the patient.

[0006] In summary, the existing aortic replacement prosthesis cannot meet the needs of most patients by relying on the anti-regurgitation pocket to "catch" the regurgitated blood at the junction of the valve leaflet, and the blood in the anti-regurgitation pocket may exist for a long time and cannot be discharged, leading to the occurrence of thrombosis and endangering the postoperative recovery of the patient. SUMMARY

[0007] In view of the above and other more ideas, the present application is proposed.

[0008] One of the purposes of the present application is to overcome the shortcomings of the prior art, for example, the stent in the prior art relies on the anti-regurgitation pocket to contain the blood regurgitated at the junction of the valve leaflet, but the amount of blood that can be contained is limited, which cannot be applied to most patients, and the blood left in the pocket may cause adverse conditions such as thrombosis if it is not discharged for a long time, and a prosthesis capable of treating valve regurgitation is provided.

[0009] The technical scheme adopted to solve the technical problems of the present application is to provide a prosthesis capable of treating valve regurgitation, comprising a radially expandable stent body, the stent body comprising a plurality of diamond-shaped meshes, and at least three clamping members provided on the outflow end of the stent body for positioning the aortic sinus and clamping the native valve leaflet; a sealing bag bulging outward is provided on the stent body between adjacent clamping members, wherein the position of the sealing bag corresponds to the junction area of the aortic valve leaflet, and the sealing bag is attached to the tissue of the junction area of the aortic valve leaflet, and the configuration is configured to guide the regurgitant blood to the two sides of the aortic sinus area when the blood regurgitates, and the part of the blood will be ejected from the aortic sinus when the aortic valve is pumped once, and will not be long-term residual in a certain area to form thrombus.

[0010] As a further improvement of the present application, the sealing bag comprises a flexible fabric layer and an embedded skeleton, the flexible fabric layer is fixed to one of the diamond-shaped meshes on the stent body in a sewn manner, and the diamond-shaped mesh is located at the junction area corresponding to the aortic valve leaflet.

[0011] As a further improvement of the present application, the embedded skeleton is composed of one or more shape memory alloy wires, wherein the embedded skeleton comprises an arc-shaped upper segment and a straight lower segment, and the arc-shaped upper end is in a preset shape.

[0012] As a further improvement of the present application, the embedded skeleton is made of nickel-titanium alloy wire.

[0013] As a further improvement of the present application, in the compressed state of the stent body, the arc-shaped upper segment is stretched into a straight line, and the embedded skeleton is located at the central axis of the diamond-shaped mesh, at this time, the length of the embedded skeleton is equivalent to the length of the two edge bars of the diamond-shaped mesh, which makes the embedded skeleton not occupy extra space when compressed and loaded, and does not adversely affect the access size of minimally invasive surgery, when the stent body is released, the arc-shaped upper segment restores to the preset arc-shaped shape and supports the fabric layer to form the sealing bag, and the position of the sealing bag is located upstream of the junction area of the aortic valve leaflet, which makes the sealing bag not need a larger size to cover the junction area of the aortic valve leaflet, and effectively guide the regurgitant blood to the two sides of the aortic sinus area.

[0014] As a further improvement of the present application, the lower end of the embedded skeleton is fixedly connected to the trough of the stent body, the upper end of the embedded skeleton is connected to the base connection point of the clamping member, and a limiting ring is provided on the stent body at the junction of the arc-shaped upper segment and the straight lower segment, the embedded skeleton passes through the limiting ring, and the limiting ring can limit the outward protrusion of the straight lower segment of the embedded skeleton, but does not affect the movement of the arc-shaped upper segment when restoring to the preset arc shape.

[0015] As a further improvement of the application, the axial projection area of the sealing bag covers the commissure of the aortic valve leaflets, the height of the sealing bag is 3-5 mm, and the width of the sealing bag is 4-7 mm.

[0016] As a further improvement of the application, the flexible fabric layer is an expanded polytetrafluoroethylene or polyester braid with a thickness of 0.1-0.3 mm, and the edges of the fabric layer are fixed on the connecting rods of the diamond grid by overlock stitching.

[0017] As a further improvement of the application, a pressing rod is arranged at the trough of the clamping piece, one end of the pressing rod is fixed on the clamping piece, the other end of the pressing rod is free, and the other end is directed towards the center of the stent body.

[0018] As a further improvement of the application, the pressing rod is designed in a T-shaped structure.

[0019] As a further improvement of the application, the pressing rod is made of nickel-titanium alloy material.

[0020] As a further improvement of the application, the release process includes the following steps: when the prosthesis is compressed and loaded, the built-in skeleton is stretched into a straight state, during the release process, the radial expansion of the stent body drives the curved upper segment of the built-in skeleton to recover to the preset curved shape; after the built-in skeleton recovers, the curved upper segment supports the flexible fabric layer and protrudes outward to form the sealing bag, and the sealing bag fits the commissure of the aortic valve leaflets.

[0021] Compared with the prior art, the technical scheme of the application has at least the following advantages: In the prior art, the regurgitation at the commissure of the valve leaflets is in the form of a bag to catch the regurgitant blood, but the blood in the bag may not be effectively discharged for a long time, resulting in thrombosis, and when the amount of regurgitant blood increases, the bag may not be able to hold the blood; according to one concept of the application, a bulging sealing bag is designed on the stent at the position of the commissure of the valve leaflets, when the blood at the commissure of the valve leaflets regurgitates, the blood will impact the sealing bag, and the sealing bag will divert the impacting blood to the adjacent aortic sinuses on both sides, thereby avoiding blood regurgitation, and at the same time, in the next blood pumping process, the blood regurgitated into the aortic sinuses will be ejected, avoiding the blood from gathering in a certain area for a long time to form thrombosis.

[0022] According to one concept of the present application, the sealing bag is composed of an inner skeleton and a fabric layer, and the inner skeleton is stretched into a straight line when the stent body is compressed, at this time, the length of the inner skeleton is equivalent to the length of two edge rods of the rhombus grid, which makes the inner skeleton not occupy extra space when compressed and loaded, and is beneficial to the approach of minimally invasive surgery, and when the stent body is released, the stent body expands and shortens, driving the arc-shaped upper segment of the inner skeleton to restore to the preset arc-shaped form and form a sealing bag, in this process, the surgeon does not need to perform additional operations, and the structure is simple and reliable, which can greatly improve the success rate of surgery.

[0023] According to one concept of the present application, the form of the arc-shaped upper segment does not cause unnecessary injury to the tissues at the junction of the aorta, improving the safety of the instrument.

[0024] The embodiments of the present application can achieve other advantageous technical effects not listed one by one, and these other technical effects are described in part in the following and can be expected and understood by those skilled in the art after reading the present application. BRIEF DESCRIPTION OF DRAWINGS

[0025] The above-mentioned features and advantages of the embodiments and other features and advantages of the embodiments and the ways to achieve them will be more apparent and can be better understood by referring to the following description in conjunction with the accompanying drawings, in which: Figure 1 It is a schematic diagram of the overall structure of the present application.

[0026] Figure 2 It is a schematic diagram of the structure of the present application after the prosthesis is compressed.

[0027] Figure 3 It is a top view of the present application after the prosthesis is implanted into the aortic valve.

[0028] Figure 4 It is Figure 3 It is a local enlarged view of the junction of the middle leaflet.

[0029] The features referred to by the numbers in the drawings are as follows: 1-stent body, 11-rhombus grid, 12-clamping piece, 13-sealing bag, 131-flexible fabric layer, 132-inner skeleton, 1321-arc-shaped upper segment, 1322-straight lower segment, 14-valley, 15-base connection point, 16-pressing rod piece. DETAILED DESCRIPTION

[0030] In the following description of the drawings and specific embodiments, the details of one or more embodiments of the present application will be set forth. From these descriptions, drawings and claims, other features, objects and advantages of the present application can be apparent.

[0031] It should be understood that the illustrated and described embodiments are not limited in application to the details of the construction and arrangement of the components set forth in the following description or illustrated in the accompanying drawings. The illustrated embodiments may be other embodiments and can be implemented or executed in various ways. Each example is provided in an explanation of the disclosed embodiments, not in a limiting manner. In fact, it will be apparent to those skilled in the art that various modifications and variations may be made to the embodiments of the present application without departing from the scope or essence of the disclosure of the present application. For example, a feature illustrated or described as part of one embodiment may be used in conjunction with another embodiment to still produce another embodiment. Therefore, the present application discloses such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0032] Likewise, it is understood that the phrases and terms used herein are for descriptive purposes and should not be considered restrictive. The use of "include," "comprising," or "having" and variations thereof herein is intended to encompass the items listed thereafter and their equivalents as well as additional items.

[0033] The present application will be described in more detail below with reference to different embodiments and examples of several aspects of the application.

[0034] One purpose of the embodiments described below is to address the above-mentioned drawbacks, as well as other problems.

[0035] Example 1

[0036] like Figure 1As shown, a prosthesis for treating valvular regurgitation according to an embodiment of the present application is shown, comprising a radially expandable stent body 1, wherein a biological valve is arranged in the stent body 1 (since the arrangement of the biological valve in the stent body 1 belongs to the prior art, reference may be made to the structure and arrangement of patent CN201320813283.2, and therefore it is not shown in the accompanying drawings), the biological valve is made of bovine pericardium or porcine pericardium, the stent body 1 comprises a plurality of diamond-shaped grids 11, and at least three clamping members 12 arranged at the outflow end of the stent body 1, for locating the aortic sinus and clamping the native valve leaflet, each clamping member 12 corresponding to one aortic sinus; an outwardly bulging sealing bag 13 is provided on the stent body 1 between adjacent clamping members 12, wherein The position of the sealing package 13 corresponds to the junction area of ​​the aortic valve leaflets, and the sealing package 13 fits the tissue of the junction area of ​​the aortic valve leaflets. The sealing package 13 includes a flexible fabric layer 131 and an internal skeleton 132. The flexible fabric layer 131 is fixed to a diamond grid 11 on the stent body 1 by suturing. The stent body 1 has two upper and lower diamond grids 11 located in the junction area of ​​the aortic valve leaflets. The flexible fabric layer 131 is sutured to the diamond grid 11 at the upper end. The configuration of the sealing package 13 is configured to guide the refluxed blood to be shunted to the adjacent aortic sinuses on both sides when blood refluxes. This part of the blood will be ejected from the aortic sinus when the aortic valve pumps blood next time, and will not remain in a certain area for a long time to form a thrombus.

[0037] In this embodiment, the built-in skeleton 132 is composed of a plurality of shape memory alloy wires, wherein the built-in skeleton 132 includes an arc-shaped upper section 1321 and a straight lower section 1322 , and the arc-shaped upper end is a preset shape.

[0038] In this embodiment, the internal skeleton 132 is made of nickel-titanium alloy wire.

[0039] In this embodiment, if Figure 2 As shown, when the stent body 1 is in a compressed state, the arc-shaped upper section 1321 is stretched into a straight line, and the built-in skeleton 132 is located at the central axis of the diamond grid 11. At this time, the length of the built-in skeleton 132 is equivalent to the length of the two side rods of the diamond grid 11, which makes the built-in skeleton 132 not take up additional space during compression loading and will not adversely affect the access size of minimally invasive surgery. When the stent body 1 is released, the arc-shaped upper section 1321 returns to the preset arc shape and supports the fabric layer to form the sealing bag 13, and the sealing bag 13 is located upstream of the aortic valve leaflet junction area, as shown in FIG. Figure 3 and Figure 4As shown, this makes the sealing bag 13 not need larger size to cover the junction area of aortic valve leaflets and effectively guide the regurgitant blood to the aortic sinus area on both sides.

[0040] In this embodiment, the lower end of the built-in skeleton 132 is fixedly connected with the trough 14 of the stent main body 1, the upper end of the built-in skeleton 132 is connected with the base connecting point 15 of the clamping piece 12, and a limiting ring is arranged at the joint of the arc-shaped upper section 1321 and the linear lower section 1322 of the stent main body 1, the built-in skeleton 132 passes through the limiting ring, and the limiting ring can limit the outward protrusion of the linear lower section 1322 of the built-in skeleton 132, but does not affect the movement of the arc-shaped upper section 1321 when recovering the preset arc shape.

[0041] In this embodiment, the limiting ring is a wire ring or a wire coil.

[0042] In this embodiment, the axial projection area of the sealing bag 13 covers the junction area of the aortic valve leaflets, the height of the sealing bag 13 is 3-5 mm, and the width of the sealing bag 13 is 4-7 mm.

[0043] In this embodiment, the flexible fabric layer 131 is expanded polytetrafluoroethylene or polyester woven fabric, and the thickness is 0.1-0.3 mm, and the edges of the fabric layer are fixed on the connecting rods of the diamond-shaped grid 11 by lockstitch sewing.

[0044] In this embodiment, the trough 14 of the clamping piece 12 is provided with a pressing rod piece 16, one end of the pressing rod piece 16 is fixed on the clamping piece 12, the other end of the pressing rod piece 16 is free, and the other end is directed to the center direction of the stent main body 1.

[0045] In this embodiment, the pressing rod piece 16 is designed in a T-shaped structure.

[0046] In this embodiment, the pressing rod piece 16 is made of nickel-titanium alloy material.

[0047] An exemplary treatment process of the aortic valve of the prosthesis for treating valve regurgitation according to the first embodiment is as follows: 1. The prosthesis is compressed and loaded into a delivery sheath, at this time, the built-in skeleton 132 is stretched into a linear state; 2. The delivery sheath is inserted into the aortic valve through a transapical method, the clamping piece 12 is released into the aortic sinus first, and then the stent main body 1 is released, at this time, the stent main body 1 is radially expanded, is shortened and drives the arc-shaped upper section 1321 of the built-in skeleton 132 to recover into a preset arc shape, the arc-shaped upper section 1321 props up the flexible fabric layer 131 and protrudes outward to form the sealing bag 13, and the sealing bag 13 is attached to the junction area of the aortic valve leaflets. 3. The system for withdrawing the delivery valve prosthesis is complete.

[0048] The foregoing description of the embodiments of the application has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit the application to the precise configuration, structures, and / or steps disclosed, and, clearly, many modifications and variations are possible in light of the above teachings. It is intended that the scope of the application and equivalents thereof be limited not by this description of embodiments but rather by the claims appended hereto.

Claims

1. A prosthesis for treating valvular regurgitation, comprising a radially expandable stent body, the stent body comprising a plurality of diamond-shaped grids, and at least three clamping members disposed at the outflow end of the stent body for locating the aortic sinus and clamping the native valve leaflets; characterized in that: An outwardly bulging sealing bag is provided on the stent body between adjacent clamping members, wherein the position of the sealing bag corresponds to the junction area of ​​the aortic valve leaflets, and the sealing bag fits the tissue of the junction area of ​​the aortic valve leaflets, and its configuration is configured to guide the refluxed blood to be diverted to both sides to the adjacent aortic sinuses when blood refluxes.

2. A prosthesis for treating valvular regurgitation according to claim 1, characterized in that: The sealing package includes a flexible fabric layer and a built-in skeleton. The flexible fabric layer is fixed to one of the diamond grids on the stent body in a sutured manner, and the diamond grid is located at a junction area corresponding to the aortic valve leaflet.

3. A prosthesis for treating valvular regurgitation according to claim 2, characterized in that: The built-in skeleton is composed of one or more shape memory alloy wires, wherein the built-in skeleton includes an arc-shaped upper section and a straight lower section, and the arc-shaped upper end is a preset shape.

4. A prosthesis for treating valvular regurgitation according to claim 3, characterized in that: When the bracket body is in a compressed state, the arc-shaped upper section is stretched into a straight line, and the built-in skeleton is located at the central axis of the diamond grid. When the bracket body is released, the arc-shaped upper section returns to a preset arc shape and supports the fabric layer to form the sealing package.

5. The prosthesis for treating valvular regurgitation according to claim 3, characterized in that: The lower end of the built-in skeleton is fixedly connected to the trough of the bracket body, the upper end of the built-in skeleton is connected to the base connection point of the clamping member, and a limiting ring is provided on the bracket body at the intersection of the arc-shaped upper section and the straight lower section, and the built-in skeleton passes through the limiting ring.

6. The prosthesis for treating valvular regurgitation according to claim 1, characterized in that: The axial projection area of ​​the sealing package covers the junction area of ​​the aortic valve leaflet, the height of the sealing package is 3-5 mm, and the width of the sealing package is 4-7 mm.

7. The prosthesis for treating valvular regurgitation according to claim 2, characterized in that: The flexible fabric layer is made of expanded polytetrafluoroethylene or polyester braid with a thickness of 0.1-0.3 mm. The edges of the fabric layer are fixed to the connecting rods of the diamond grid by means of lockstitching.

8. The prosthesis for treating valvular regurgitation according to claim 1, characterized in that: A pressure rod is provided at the trough of the clamping member, one end of the pressure rod is fixed on the clamping member, and the other end of the pressure rod is free and faces the center direction of the bracket body.

9. The prosthesis for treating valvular regurgitation according to claim 8, characterized in that: The compression rod is designed in a T-shaped structure.

10. A method for releasing a prosthesis for treating valvular regurgitation, comprising the prosthesis according to claim 1-9, characterized in that The method comprises the following steps: when the prosthesis is compressed and loaded, the internal skeleton is stretched into a straight state; during the release process, the radial expansion of the stent body drives the arc-shaped upper section of the internal skeleton to restore to a preset arc shape; After the shape of the built-in skeleton is restored, the arc-shaped upper section props up the flexible fabric layer and protrudes outward to form the sealing bag, and the sealing bag fits the junction area of ​​the aortic valve leaflet.

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