Prostheses and methods of delivery for treating valve regurgitation

Abstract

The application relates to the field of medical devices, in particular to 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 arranged at the outflow end of the stent body, used for positioning the aortic sinus and clamping the native valve leaflets; a sealing bag bulging outward is arranged 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 is attached to the tissue of the junction area of the aortic valve leaflets, and the configuration of the sealing bag is configured to guide the regurgitant blood to flow to the adjacent aortic sinuses on both sides when the blood regurgitates; in the application, the sealing bag guides the regurgitant blood to flow to the adjacent aortic sinuses in a diversion manner, so that blood regurgitation is avoided, and meanwhile, when the aorta pumps blood again, the blood in the aortic sinus is ejected, so that blood stasis is avoided.

Description

Technical Field

[0001] This application relates to the field of medical devices, and more particularly to a prosthesis for treating valvular regurgitation and a method for its release. Background Technology

[0002] With the continuous increase in life expectancy and the increasingly serious trend of global population aging, the incidence of valvular heart disease has shown a significant increasing trend. Among elderly patients, the incidence of valvular heart disease ranks third, after hypertension and coronary heart disease, with an incidence rate as high as 13.3%.

[0003] Heart valve diseases include aortic valve disease, mitral valve disease, tricuspid valve disease, and pulmonary valve disease. Among them, aortic valve disease includes aortic stenosis and aortic regurgitation. Aortic stenosis is mainly caused by calcification of the valve leaflets, which reduces the opening area of ​​the leaflets, preventing sufficient blood flow from the left ventricle to the aorta, resulting in increased intraventricular pressure. Aortic regurgitation mainly occurs during diastole, when the valve leaflets cannot close completely, causing blood flowing into the aorta to flow back into the left ventricle, resulting in increased intraventricular pressure.

[0004] In recent years, due to its advantages such as minimal invasiveness and rapid recovery, transcatheter aortic valve replacement (TCV) has gradually become an alternative to surgical treatment for aortic valve disease. Currently, most aortic prostheses on the market are designed for aortic stenosis, while options for aortic regurgitation are limited. Furthermore, long-term clinical observations have revealed that regurgitation persists at the leaflet junction after aortic prosthesis implantation, and long-term implantation can lead to complications such as thrombosis.

[0005] Patent CN202211080434.8 discloses an aortic prosthesis that prevents reflux at the junction, comprising a stent for support and anchoring, a positioning element for positioning and clamping the autologous valve leaflet, and a leak-proof mechanism. The stent includes multiple expandable rhomboid meshes, and the leak-proof mechanism includes a sealing membrane and a support rod. One end of the support rod is connected to the rhomboid mesh located between adjacent positioning elements and extends downward to form a filling portion convex to the outside of the stent. The other end of the support rod is free, and the sealing membrane is connected to the rhomboid mesh. When the aortic prosthesis is installed in place, the filling portion is located at the junction of the autologous valve leaflet and abuts against the vascular tissue, causing the filling portion to tilt the other end of the support rod outward from the stent with the connection point between the support rod and the rhomboid mesh as a fulcrum. The sealing membrane unfolds with the support rod to form an anti-reflux pocket to prevent blood backflow. This patented solution also addresses the issue of reflux at the junction and utilizes an anti-reflux sac to trap the refluxed blood. However, this anti-reflux sac faces the ascending aorta. If the amount of refluxed blood is large, the anti-reflux sac cannot completely trap it, causing some blood to still flow back into the left ventricle. Furthermore, some blood within the anti-reflux sac may not be able to drain, potentially leading to blood clots within the sac over time, endangering the patient's health.

[0006] In summary, existing aortic replacement prostheses, which rely on anti-reflux pockets to "catch" the refluxed blood at the leaflet junction, cannot meet the needs of most patients. Furthermore, the blood in the anti-reflux pocket may remain for a long time without being drained, leading to thrombosis and jeopardizing the patient's postoperative recovery. Summary of the Invention

[0007] This application is made in view of the above and other ideas.

[0008] One of the purposes of this application is to overcome the shortcomings of the prior art, such as the fact that the existing stent relies on an anti-reflux pocket to catch the refluxed blood at the leaflet junction, but the amount of blood that can be caught is limited and cannot be applied to most patients. Furthermore, the blood remaining in the pocket for a long time may lead to the adverse condition of thrombosis. This application provides a prosthesis that can treat valvular regurgitation.

[0009] The technical solution adopted to solve the technical problem of the present invention is to provide a prosthesis for treating valvular regurgitation, comprising a radially expandable stent body, the stent body including a plurality of rhomboid meshes, and at least three clamping members disposed at the outflow end of the stent body for positioning the aortic sinus and clamping the autologous valve leaflets; the stent body between adjacent clamping members is provided with an outwardly bulging sealing package, wherein the position of the sealing package corresponds to the junction area of ​​the aortic valve leaflets, and the sealing package conforms to the tissue of the junction area of ​​the aortic valve leaflets, and its configuration is configured to guide the regurgitated blood to the sides to the adjacent aortic sinus when blood regurgitates, and this part of the blood will be ejected from the aortic sinus when the aortic valve pumps blood again, and will not remain in a certain area for a long time to form a thrombus.

[0010] As a further improvement of the invention, the sealing package includes a flexible fabric layer and an internal skeleton, the flexible fabric layer being stitched to one of the rhomboid grids on the stent body, and the rhomboid grid being located in the junction area corresponding to the aortic valve leaflets.

[0011] As a further improvement of the present invention, 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 has a preset shape.

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

[0013] As a further improvement of the present invention, when the stent body is compressed, the upper arc-shaped section is stretched into a straight line, and the built-in skeleton is located at the central axis of the rhomboid grid. At this time, the length of the built-in skeleton is equivalent to the length of the two side bars of the rhomboid grid. This makes it possible for the built-in skeleton not to occupy additional space when compressed and loaded, and not to adversely affect the access size of the minimally invasive surgery. When the stent body is released, the upper arc-shaped section returns to the preset arc shape and supports the fabric layer to form the sealing package. The sealing package is located upstream of the aortic leaflet junction area, which means that the sealing package does not need to be large in size to cover the aortic leaflet junction area and effectively guide the regurgitated blood to the aortic sinus areas on both sides.

[0014] As a further improvement of the present invention, the lower end of the built-in skeleton is fixedly connected to the trough of the support 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 support body at the junction of the arc-shaped upper section and the straight lower section. The built-in skeleton passes through the limiting ring. The limiting ring can restrict the straight lower section of the built-in skeleton from protruding outward, but does not affect the movement of the arc-shaped upper section when restoring the preset arc shape.

[0015] As a further improvement of the present invention, the axial projected area of ​​the sealing package covers the junction area of ​​the aortic valve leaflets, the height of the sealing package is 3-5mm, and the width of the sealing package is 4-7mm.

[0016] As a further improvement of the present invention, the flexible fabric layer is expanded polytetrafluoroethylene or polyester woven fabric with a thickness of 0.1-0.3 mm, and the edge of the fabric layer is fixed to the connecting rod of the diamond grid by overlock stitching.

[0017] As a further improvement of the present invention, a pressure rod is provided at the trough of the clamping member, one end of the pressure rod is fixed to the clamping member, the other end of the pressure rod is free, and the other end is directed toward the center of the support body.

[0018] As a further improvement of the present invention, the pressure bar is designed with a T-shaped structure.

[0019] As a further improvement of the present invention, the pressure bar is made of nickel-titanium alloy material.

[0020] As a further improvement of the present invention, the following release step is included: 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 causes the upper arc-shaped section of the built-in skeleton to return to a preset arc shape. After the shape of the built-in skeleton is restored, the upper arc-shaped section supports the flexible fabric layer and protrudes outward to form the sealing package. Furthermore, the sealing package fits the junction area of ​​the aortic valve leaflets.

[0021] Compared with the prior art, the advantages of the technical solution of this application include at least the following:

[0022] In existing technologies, reflux at the leaflet junction is addressed by using a sac to catch the refluxed blood. However, the blood in the sac may not be effectively drained over a long period, leading to thrombosis. Furthermore, when the amount of refluxed blood increases, the sac may become unable to hold the blood. According to a concept proposed in this application, a bulging sealing pouch is designed on the stent at the leaflet junction. When refluxed blood occurs at the leaflet junction, the blood impacts the sealing pouch, which then diverts the impacted blood to the adjacent aortic sinus, thereby preventing blood reflux. Simultaneously, during the next pumping cycle, the refluxed blood in the aortic sinus is ejected, preventing blood from accumulating in one area and forming a thrombus.

[0023] According to a concept of this application, the sealing package consists of an internal skeleton and a fabric layer. When the stent body is compressed, the internal skeleton is stretched into a straight line. At this time, the length of the internal skeleton is equivalent to the length of the two side bars of the diamond grid. This means that the internal skeleton does not occupy extra space when compressed and loaded, which is beneficial for the access of minimally invasive surgery. When the stent body is released, the stent body expands and shortens, causing the upper arc-shaped section of the internal skeleton to return to the preset arc shape and form a sealing package. During this process, no additional operation is required from the surgeon. Its structure is simple and reliable, which can greatly improve the success rate of surgery.

[0024] According to a concept of this application, the shape of the arc-shaped upper segment will not cause unnecessary puncture to the tissue at the aortic junction, thus improving the safety of the device.

[0025] The embodiments of this application can achieve other advantageous technical effects not listed one by one. These other technical effects may be partially described below and can be expected and understood by those skilled in the art after reading this application. Attached Figure Description

[0026] The above-described features and advantages, as well as other features and advantages, and the ways in which they are implemented, of these embodiments will become more apparent and the embodiments of this application will be better understood by referring to the following description in conjunction with the accompanying drawings, in which:

[0027] Figure 1 This is a schematic diagram of the overall structure of the present invention.

[0028] Figure 2 This is a schematic diagram of the structure of the prosthesis of the present invention after compression.

[0029] Figure 3 This is a top view of the prosthesis of the present invention after it has been implanted into the aortic valve.

[0030] Figure 4 for Figure 3 A magnified view of the junction of the middle petals.

[0031] The features represented by the numbers in the attached diagram are as follows:

[0032] 1-Support body, 11-Rhombus grid, 12-Clamping component, 13-Sealing package, 131-Flexible fabric layer, 132-Built-in skeleton, 1321-Arc-shaped upper section, 1322-Straight lower section, 14-Valley, 15-Base connection point, 16-Pressure bar component. Detailed Implementation

[0033] The details of one or more embodiments of this application will be set forth in the following description of the accompanying drawings and specific embodiments. Other features, objects, and advantages of this application will become clear from these descriptions, drawings, and claims.

[0034] 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 performed in various ways. The examples are provided by way of explanation rather than limitation of the disclosed embodiments. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments of this application without departing from the scope or spirit of this disclosure. For example, features illustrated or described as part of one embodiment may be used with another embodiment to still produce another embodiment. Therefore, this disclosure covers such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0035] Similarly, it is understood that the phrases and terms used in this document are for descriptive purposes and should not be considered restrictive. The use of “including,” “contains,” or “has,” and their variations, in this document is intended to include, in an open-ended manner, the items listed thereafter, their equivalents, and any additional items.

[0036] The present application will now be described in more detail with reference to various embodiments and examples of several aspects thereof.

[0037] One of the objectives of the embodiments described below is to address the aforementioned deficiencies, as well as other problems.

[0038] Example 1

[0039] like Figure 1The illustration shows a prosthesis for treating valvular regurgitation according to an embodiment of this application, comprising a radially expandable stent body 1. A bioprosthetic valve is disposed within the stent body 1 (since the placement of the bioprosthetic valve within the stent body 1 is prior art, please refer to the structure and placement method of patent CN201320813283.2, it is not shown in the accompanying drawings). The bioprosthetic valve is made from bovine or porcine pericardium. The stent body 1 includes multiple rhomboid meshes 11 and at least three clamping members 12 located at the outflow end of the stent body 1 for positioning the aortic sinus and clamping the autologous valve leaflet. Each clamping member 12 corresponds to one aortic sinus. An outwardly bulging sealing package 13 is provided on the stent body 1 between adjacent clamping members 12. The sealing package 13 is positioned corresponding to the junction area of ​​the aortic valve leaflets, and the sealing package 13 adheres to 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 rhomboid mesh 11 on the stent body 1 by suturing. There are two rhomboid meshes 11 on the stent body 1 located in the junction area of ​​the aortic valve leaflets, one above the other. The flexible fabric layer 131 is suturing to the upper rhomboid mesh 11. The configuration of the sealing package 13 is designed to guide the refluxed blood to the sides and into the adjacent aortic sinus when blood reflux occurs. This part of the blood will be ejected from the aortic sinus when the aortic valve pumps blood once, and will not remain in a certain area for a long time to form a thrombus.

[0040] In this embodiment, the built-in skeleton 132 is composed of multiple 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.

[0041] In this embodiment, the built-in skeleton 132 is made of nickel-titanium alloy wire.

[0042] In this embodiment, as Figure 2 As shown, in the compressed state, the upper arc-shaped section 1321 of the stent body 1 is stretched into a straight line, and the internal skeleton 132 is located at the central axis of the rhomboid mesh 11. At this time, the length of the internal skeleton 132 is equivalent to the length of the two side bars of the rhomboid mesh 11. This ensures that the internal skeleton 132 does not occupy additional space during compression loading and does not adversely affect the access size of the minimally invasive surgery. When the stent body 1 is released, the upper arc-shaped section 1321 returns to the preset arc shape and supports the fabric layer to form the sealing package 13. The sealing package 13 is located upstream of the aortic valve leaflet junction area, as shown. Figure 3 and Figure 4As shown, this allows the sealing package 13 to cover the aortic valve leaflet junction area without requiring a large size, and effectively guides the regurgitated blood to the aortic sinus regions on both sides.

[0043] In this embodiment, the lower end of the built-in skeleton 132 is fixedly connected to the trough 14 of the support body 1, and the upper end of the built-in skeleton 132 is connected to the base connection point 15 of the clamping member 12. Furthermore, a limiting ring is provided on the support body 1 at the junction of the arc-shaped upper segment 1321 and the straight lower segment 1322. The built-in skeleton 132 passes through the limiting ring. The limiting ring can restrict the straight lower segment 1322 of the built-in skeleton 132 from protruding outward, but does not affect the movement of the arc-shaped upper segment 1321 when restoring the preset arc shape.

[0044] In this embodiment, the limiting ring is a wire loop or coil.

[0045] In this embodiment, the axial projected area of ​​the sealing package 13 covers the junction area of ​​the aortic valve leaflets, the height of the sealing package 13 is 3-5mm, and the width of the sealing package 13 is 4-7mm.

[0046] In this embodiment, the flexible fabric layer 131 is expanded polytetrafluoroethylene or polyester woven fabric with a thickness of 0.1-0.3 mm, and the edge of the fabric layer is fixed to the connecting rod of the diamond mesh 11 by overlock stitching.

[0047] In this embodiment, a pressure rod 16 is provided at the trough 14 of the clamping member 12. One end of the pressure rod 16 is fixed to the clamping member 12, and the other end of the pressure rod 16 is free and faces the center of the support body 1.

[0048] In this embodiment, the pressure bar 16 has a T-shaped structure design.

[0049] In this embodiment, the pressure bar 16 is made of nickel-titanium alloy.

[0050] The following is an exemplary procedure for treating aortic valve disease using a prosthesis for treating valvular regurgitation, as described in Example 1:

[0051] 1. The prosthesis is compressed and installed inside the delivery sheath, at which time the internal skeleton 132 is stretched into a straight state;

[0052] 2. The delivery sheath enters the aortic valve via the apex of the heart. First, the clamp 12 is released into the aortic sinus, and then the stent body 1 is released. At this time, the stent body 1 expands radially, shortens, and drives the upper arc-shaped section 1321 of the built-in skeleton 132 to return to the preset arc shape. The upper arc-shaped section 1321 supports the flexible fabric layer 131 and protrudes outward to form the sealing package 13. The sealing package 13 fits the junction area of ​​the aortic valve leaflets.

[0053] 3. Withdraw the system that delivers the valve prosthesis and complete the surgery.

[0054] The foregoing description of the embodiments described above is provided for illustrative purposes. This foregoing description is not intended to be exhaustive, nor is it intended to limit the application to the precise configurations, constructions, and / or steps disclosed. Clearly, many modifications and variations can be made in light of the teachings above. The scope of the invention and all its equivalents are intended to be defined by the appended claims.

Claims

1. A prosthetic device for treating valvular regurgitation, comprising a radially expandable stent body, said stent body comprising a plurality of diamond-shaped meshes, and at least three clamps provided at the outflow end of the stent body for positioning the aortic sinus and clamping native leaflets; characterized in that: The sealing bag is outwardly bulged on the stent body between the adjacent clamping members, wherein the sealing bag is located at the junction of the aortic valve leaflets, and the sealing bag is attached to the tissue of the junction of the aortic valve leaflets, and the configuration of the sealing bag is configured to guide the regurgitant blood to flow to both sides into the adjacent aortic sinus when the blood regurgitates, the sealing bag comprises a flexible fabric layer and an embedded skeleton, the flexible fabric layer is fixed to one of the diamond meshes on the stent body in a sewn manner, and the diamond mesh is located at the junction of the aortic valve leaflets, the embedded skeleton comprises an arc-shaped upper segment and a straight lower segment, the arc-shaped upper segment is in a preset shape, the arc-shaped upper segment is stretched into a straight line in the compressed state of the stent body, and the embedded skeleton is located at the central axis of the diamond mesh, 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, the lower end of the embedded skeleton is fixedly connected to the trough of the stent body, and the upper end of the embedded skeleton is connected to the base connection point of the clamping member.

2. The prosthetic device of claim 1, wherein: The embedded skeleton is composed of one or more shape memory alloy wires.

3. The prosthetic device of claim 1, wherein: A limiting ring is arranged at the junction of the arc-shaped upper segment and the straight lower segment on the stent body, and the embedded skeleton passes through the limiting ring.

4. The prosthetic device of claim 1, wherein: The axial projection area of the sealing bag covers the junction 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.

5. The prosthetic device of claim 1, wherein: The flexible fabric layer is expanded polytetrafluoroethylene or polyester knitted fabric, and the thickness is 0.1-0.3 mm, and the edges of the fabric layer are fixed to the connecting rods of the diamond mesh in a lock-stitch manner.

6. The prosthetic device of claim 1, wherein: A pressing rod is arranged at the trough of the clamping member, one end of the pressing rod is fixed to the clamping member, the other end of the pressing rod is free, and the other end is directed to the center of the stent body.

7. A prosthesis treatable for valve regurgitation according to claim 6, characterized in that: The pressing rod is designed in a T-shaped structure.

8. A method of releasing a prosthetic device for treating valvular regurgitation comprising the prosthetic device of claims 1-7, characterized in that The steps include that when the prosthesis is compressed and loaded, the embedded skeleton is stretched into a straight line, and during the release process, the radial expansion of the stent body drives the arc-shaped upper segment of the embedded skeleton to restore to the preset arc-shaped shape. After the shape of the embedded skeleton is restored, the arc-shaped upper segment supports the flexible fabric layer and protrudes outward to form the sealing bag, and the sealing bag is attached to the junction of the aortic valve leaflets.

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