Valve prosthesis for preventing paravalvular leakage and delivery system thereof

Abstract

This application belongs to the field of medical devices, specifically relating to a valve prosthesis and its delivery system for preventing paravalvular leakage. It includes a leak-proof device and a stent. The stent includes a valve suture segment. The leak-proof device is connected to the proximal portion of the stent. The leak-proof device has an irregular structure and has a first form and a second form. When the leak-proof device is in the first form, it is offset from the valve suture segment in the axial direction. When the leak-proof device changes from the first form to the second form, it returns to the preset form along a preset path towards the distal end of the stent, and at least a portion of the leak-proof device overlaps with the valve suture segment in the axial direction. This invention achieves a significant reduction in tube diameter and can specifically adapt to the physiological structure of the autologous valve, allowing it to better fit the autologous valve annulus and atrial tissue, effectively preventing regurgitation.

Description

Technical Field

[0001] This application belongs to the field of medical devices, specifically relating to valve prostheses and their delivery systems for preventing paravalvular leakage. Background Technology

[0002] Tricuspid regurgitation is generally caused by pulmonary hypertension, right ventricular enlargement, and tricuspid annular dilation. Clinically, it often presents with symptoms of the underlying cause of tricuspid regurgitation (left heart failure, pulmonary hypertension, etc.). After the onset of tricuspid regurgitation, symptoms of right heart failure such as fatigue, ascites, edema, liver pain, indigestion, and loss of appetite worsen. Mild tricuspid regurgitation may not present with obvious clinical symptoms, but severe regurgitation requires surgical treatment.

[0003] Traditional treatments for mitral and tricuspid valve disease include medication for mild to severe regurgitation and surgical procedures when indicated. Surgical procedures include valve replacement and valve repair. However, typical open-heart surgery is highly invasive, requires cardiopulmonary bypass, and carries a high risk of complications and infection. Many patients cannot tolerate the significant surgical risks and are left with no choice but to await death.

[0004] Following the report of the first aortic valve replacement surgery, numerous companies have conducted extensive research in interventional aortic valve technology, which has become increasingly mature. However, a significant gap remains in the field of interventional treatment for atrioventricular valves. Although a few products for interventional treatment of atrioventricular valves have been applied in transcatheter valve repair and angioplasty, no mature products have yet been launched internationally for transcatheter valve replacement.

[0005] Patent CN106264793B discloses an adaptive heart valve prosthesis, which includes a stent and an artificial valve. The stent comprises a leak-proof ring and a valve suture segment. The leak-proof ring is connected to the valve suture segment, and the artificial valve is fixedly connected to the valve suture segment. The valve suture segment is at least partially located between the patient's own valve leaflets. In a cross-section perpendicular to the central axis of the artificial valve, the cross-sectional area of ​​the valve suture segment is smaller than the cross-sectional area of ​​the patient's own valve annulus, so that the valve suture segment does not directly radially expand the patient's own valve annulus. In a free state, the cross-sectional area of ​​the leak-proof ring is larger than the cross-sectional area of ​​the patient's own valve annulus. The leak-proof ring can conform to the uneven contour of the atrial cavity wall or the patient's own valve annulus. While the anti-leakage ring in this technical solution can effectively prevent paravalvular leakage, it is fixed to the valve suture segment. During loading, the anti-leakage ring overlaps with the valve suture segment, preventing the loading tube diameter from being reduced and thus failing to meet the requirements of transvascular access. At the same time, the overlap between the anti-leakage ring and the valve suture segment greatly increases the pressure on the artificial valve during loading, which can easily damage the artificial valve and affect the lifespan of the valve prosthesis.

[0006] Patent CN106999279B discloses a transcatheter valve prosthesis including a tubular stent, comprising: an inner skirt or skirt portion connected to and covering the inner peripheral surface of the stent; and an outer skirt or skirt portion connected to and covering the outer peripheral surface of the stent. The prosthesis valve component is disposed within and fixed to the inner skirt or skirt portion. In this technical solution, the leak-proof ring and the valve suture segment do not overlap in their natural state. Although this does not affect the loading tubing diameter, it results in an increased overall length of the valve prosthesis. Its structure is only suitable for use in the aorta. However, the physiological structure of the ventricles is complex, and implanting an excessively long stent into the atrioventricular valve can cause the stent to become entangled with the chordae tendineae, potentially leading to conduction block or puncture into the apical tissue, causing damage.

[0007] Patent CN 202011314457.1 discloses an artificial heart valve, including a mesh structure and a tricuspid valve. The mesh structure includes a small-diameter segment, a folded segment, and a large-diameter segment. The small-diameter segment transitions to the large-diameter segment via the folded segment. In its natural state, the folded segment is axially folded, forming an inner and outer two-layer structure with unequal diameters between the small-diameter and large-diameter segments. When subjected to axial stretching by an external force, the small-diameter segment, the folded segment, and the large-diameter segment are axially stretched to present a single-layer structure. A tricuspid valve is placed within the small-diameter segment, and an anchor is placed on the outer surface of the large-diameter segment. Although this technical solution can reduce the loading tube diameter, due to the complex and irregular physiological structure of the tricuspid valve, the D-shaped large-diameter segment cannot meet the leakage prevention requirements. Furthermore, the anchor on the outer surface of the large-diameter segment makes it impossible to retrieve after release, resulting in low error tolerance and extremely high operational requirements for clinical personnel.

[0008] Therefore, those skilled in the art are dedicated to developing an atrioventricular valve prosthesis that can reduce the loading tube diameter, meet the requirements of transvascular access, effectively prevent paravalvular leakage, and avoid damage to ventricular tissue.

[0009] Application content

[0010] The technical problem to be solved by the present invention is to provide an atrioventricular valve prosthesis that can reduce the loading tube diameter, meet the requirements of transvascular access, effectively prevent paravalvular leakage, and avoid damage to ventricular tissue.

[0011] To solve the above-mentioned technical problems, this application provides the following technical solution:

[0012] Human heart valves have anterior leaflets, posterior leaflets, and diaphragmatic leaflets. These leaflets are closed during heart contraction. When the anterior leaflets, posterior leaflets, and diaphragmatic leaflets cannot fully align in the closed state, valve regurgitation occurs.

[0013] According to one aspect of the present invention, a valve prosthesis for preventing paravalvular leakage includes a leak-proof device and a support, the support including a valve suture segment, the leak-proof device being connected to a proximal portion of the support, the leak-proof device being an irregularly shaped structure, the leak-proof device having a first form and a second form, wherein when the leak-proof device is in the first form, the leak-proof device and the valve suture segment are staggered in the axial direction, and when the leak-proof device is in the second form, at least a portion of the leak-proof device and the valve suture segment overlap in the axial direction.

[0014] The objective of this invention can also be further achieved through the following technical solutions:

[0015] According to one embodiment, when the leak-proof device changes from a first form to a second form, the leak-proof device returns to the preset form along a preset path toward the far end of the bracket.

[0016] According to one embodiment, the leak prevention device includes a transition section, a valve annulus adaptation section, and an atrial adaptation section. The transition section is connected to the proximal end of the stent, and the valve annulus adaptation section is provided with a first protrusion and a second protrusion adapted to the morphology of the autologous valve annulus.

[0017] According to one embodiment, when the leak-proof device is in the first state, the first protrusion and the second protrusion are stretched into a linear shape. When the leak-proof device changes from the first state to the second state, the first protrusion and the second protrusion return to the preset shape along a preset path and abut against the autologous valve annulus tissue.

[0018] According to one embodiment, when the valve prosthesis is implanted into the heart, the first protrusion and the second protrusion are located in the septal region and posterior region of the autologous valve, respectively.

[0019] According to one embodiment, the rigidity of the valve annulus adaptation segment is greater than that of the atrial adaptation segment; the valve annulus adaptation segment has a certain rigidity, which can better support and conform to the autologous tissue and avoid regurgitation.

[0020] According to one embodiment, the transition section is generally S-shaped.

[0021] According to one embodiment, the transition section includes a first arc-shaped section, which is connected to the proximal end of the bracket, and the first arc-shaped section is a flexible section; the design of the first arc-shaped section is to prevent the leakage prevention device from being subjected to excessive stress during the stretching process, which could cause difficulties in loading, fatigue damage or even breakage at the connection.

[0022] According to one embodiment, the transition segment includes a second arc-shaped segment connected to the annular adaptation segment, and the rigidity of the second arc-shaped segment is greater than that of the first arc-shaped segment.

[0023] According to one embodiment, the stent has a mesh-like structure and includes multiple axially arranged unit waves. The transition section is fixedly connected to the stent between adjacent unit waves. The advantage of this design is that during pre-installation, the leak-proof device and the valve sewing section do not overlap, which can minimize the loading tube diameter and reduce the pressure on the artificial valve during loading, thus avoiding damage to the artificial valve. The transition section can be fixed to the stent by welding, sewing, or other fixed connection methods.

[0024] According to one embodiment, the cross-section of the atrial adaptation segment is elliptical, circular, D-shaped, or saddle-shaped, and the atrial adaptation segment is provided with a plurality of connecting rings, which are evenly distributed in the circumferential direction of the atrial adaptation segment.

[0025] According to one embodiment, the delivery system includes a delivery catheter, a controllable release device, and a valve prosthesis. The valve prosthesis includes a leak-proof device, a stent, and an artificial valve. The controllable release device is detachably connected to the leak-proof device. During pre-installation, the controllable release device and the valve prosthesis are disposed within the delivery catheter. When the leak-proof device is released or retrieved, manipulating the controllable release device can cause the leak-proof device to return to a preset shape or a restricted shape along a preset route.

[0026] According to one embodiment, the leak-proof device includes an atrial adaptation section, a valve annulus adaptation section, and a transition section. When the leak-proof device is in a restricted state, the transition section, valve annulus adaptation section, and valve suture section are staggered in the axial direction within the delivery catheter. When the leak-proof device returns to a preset state, at least a portion of the transition section, valve annulus adaptation section, and valve suture section overlap in the axial direction.

[0027] According to one embodiment, the center of the leak-proof device does not coincide with the center of the valve suture segment, and when retrieving the leak-proof device, the controllable release device is manipulated so that the portion of the leak-proof device away from the center of the valve suture segment is pre-retracted into the delivery catheter.

[0028] According to one embodiment, the controllable release device includes a control component and a disassembly component. The distal end of the control component is provided with a locking ring. During pre-installation, after the locking ring passes through the connecting ring, the distal end of the disassembly component is inserted into the locking ring. When the controllable release device is operated to tighten and lock the control component, a connection is formed between the leak-proof device, the control component, and the disassembly component, fixing their relative positions. When the disassembly component is operated to move axially so that the distal end of the disassembly component disengages from the locking hole, the leak-proof device is released from the control component.

[0029] Compared with the prior art, the advantages of this application are:

[0030] 1. Unlike existing technologies, in one embodiment of the present invention, the leak-proof device has an irregular shape, which can be specifically adapted to the shape of the autologous valve, resulting in a better leak-proof effect. At the same time, the leak-proof device can effectively reduce the loading tube diameter in the first form, and when it is converted from the first form to the second form, it can restore its preset shape according to the preset path. This not only achieves a significant reduction in tube diameter, but also specifically adapts to the physiological structure of the autologous valve, allowing it to better fit the autologous valve annulus and atrial tissue, effectively preventing regurgitation.

[0031] 2. Unlike the prior art, in one embodiment of the present invention, the valve annulus adaptation section is provided with a first protrusion and a second protrusion adapted to the shape of the autologous valve annulus. During pre-installation, the first protrusion and the second protrusion are stretched into a linear shape. During release, the first protrusion and the second protrusion return to the preset shape and abut against the autologous valve annulus tissue. This satisfies the pipe diameter requirements of the delivery system during loading and also allows the leak-proof device to fit tightly against the autologous tissue, thus achieving a good leak-proof effect.

[0032] 3. Unlike the prior art, in one embodiment of the present invention, when the valve prosthesis is pre-installed, the anti-leakage device and the valve sewing section do not overlap, which can minimize its loading tube diameter and reduce the pressure on the artificial valve during loading, thus avoiding damage to the artificial valve.

[0033] 4. Unlike existing technologies, in one embodiment of the present invention, the controllable release device and the leak-proof device are detachably connected. Furthermore, the controllable release device can control the release and retrieval of the leak-proof device. When the leak-proof device is released and a deviation in its release position is found, the leak-proof device can be retrieved into the delivery catheter along a preset path by manipulating the controllable release device. This overcomes the drawback of existing leak-proof devices being non-retrievable, has a higher fault tolerance rate, and can still be readjusted after the valve prosthesis is released, which has great clinical significance.

[0034] 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

[0035] 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:

[0036] Figures 1a-1b This is a schematic diagram of the leak-proof device and support of the present invention.

[0037] Figures 2a-2bThis is a schematic diagram showing the morphology of the transition segment, valve annulus adaptation segment, and atrial adaptation segment of the present invention, as well as a schematic diagram showing the structure of the first protrusion and the second protrusion.

[0038] Figures 3a-3d This is a schematic diagram showing the state of the leak-proof device in the conveying system and the process of releasing the leak-proof device.

[0039] Figures 4a-4c This is a schematic diagram showing that the center of the leak-proof device and the support do not coincide, and a schematic diagram showing the process of recycling the leak-proof device.

[0040] Figures 5a-5d This is a schematic diagram and a schematic diagram of the structure and principle of the controllable release device of the present invention, which is connected and released by the connecting ring.

[0041] The parts referred to by the numbers in the attached diagram are as follows: 1-leakage prevention device, 11-transition section, 111-first arc-shaped section, 112-second arc-shaped section, 12-annular adaptation section, 121-first protrusion, 122-second protrusion, 13-atrial adaptation section, 131-connecting ring, 2-stent, 21-valve suture section, 22-unit wave, 3-delivery system, 31-delivery catheter, 32-controllable release device, 321-control element, 3211-locking ring, 322-disassembly element, 33-valve prosthesis, 331-artificial valve. Detailed Implementation

[0042] The present application will now be described in further detail with reference to the accompanying drawings and embodiments.

[0043] The proximal end, as described in this application, refers to the end closer to the surgical operator, while the distal end refers to the end farther away from the surgical operator. Specific Implementation Example 1:

[0045] 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.

[0046] 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.

[0047] 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.

[0048] The present application will now be described in more detail with reference to various embodiments and examples of several aspects thereof.

[0049] In this application, "proximal end" refers to the end closer to the surgeon, and "distal end" refers to the end farther away from the surgeon.

[0050] Example 1

[0051] The tricuspid valve of the human heart has anterior leaflet, posterior leaflet, and diaphragmatic leaflet. The anterior leaflet, posterior leaflet, and diaphragmatic leaflet are in a closed state when the heart contracts. When any one of the anterior leaflet, posterior leaflet, or diaphragmatic leaflet fails to close properly, valvular regurgitation occurs.

[0052] According to one example, a valve prosthesis for preventing paravalvular leakage includes a leak-proof device 1 and a support 2, wherein the support 2 includes a valve suture segment 21, such as... Figures 1a-1b As shown, the leak-proof device 1 and the proximal portion of the support 2 are connected. The leak-proof device 1 has an irregular structure and has a first form and a second form. When the leak-proof device 1 is in the first form, it is offset from the valve suture segment 21 in the axial direction. When the leak-proof device 1 changes from the first form to the second form, it returns to the preset form along a preset path towards the distal end of the support 2, and at least part of the leak-proof device 1 overlaps with the valve suture segment 21 in the axial direction. When device 1 is in the second form, at least part of the leak-proof device 1 overlaps with the valve suture segment 21 in the axial direction; the leak-proof device 1 is connected to the proximal end of the stent 2, and in the first form, the leak-proof device 1 is stretched towards the proximal end of the stent 2 to make it staggered, thereby reducing its loading tube diameter. At the same time, the direction of this stretching can allow the leak-proof device 1 to change from the first form to the second form, and also from the second form to the first form. It has a high fault tolerance rate and can still be repositioned and adjusted to the most suitable fixed position for the patient after intracardiac release, which has good clinical significance.

[0053] In this embodiment, the leak-proof device 1 includes a transition section 11, a valve annulus adaptation section 12, and an atrial adaptation section 13. The transition section 11 is connected to the proximal end of the stent 2. The valve annulus adaptation section 12 is provided with a first protrusion 121 and a second protrusion 122 adapted to the morphology of the autologous valve annulus. Figure 2a As shown.

[0054] In this embodiment, when the leak-proof device 1 is in the first state, the first protrusion 121 and the second protrusion 122 are stretched into a linear shape. When the leak-proof device 1 changes from the first state to the second state, the first protrusion 121 and the second protrusion 122 return to their preset shape along a preset path and abut against the autologous valve annulus tissue, such as... Figure 2b As shown.

[0055] In this embodiment, when the valve prosthesis is implanted into the heart, the first protrusion 121 and the second protrusion 122 are located in the septal valve region and the posterior valve region of the autologous valve, respectively.

[0056] In this embodiment, the rigidity of the valve annulus adaptation segment 12 is greater than that of the atrial adaptation segment 13; the valve annulus adaptation segment 12 has a certain rigidity, which can better support and fit the autologous tissue and avoid reflux.

[0057] The transition section 11 includes a first arc-shaped section 111, which is connected to the proximal end of the bracket 2, and the first arc-shaped section 111 is a flexible section. The design of the first arc-shaped section 111 is to prevent the leakage prevention device 1 from being subjected to excessive stress during the stretching process, which could cause difficulties in loading, fatigue damage or even breakage at the connection.

[0058] In this embodiment, the transition segment 11 includes a second arc segment 112, which is connected to the valve annulus adaptation segment 12, and the rigidity of the second arc segment 112 is greater than that of the first arc segment 111.

[0059] In this embodiment, the support 2 has a mesh-like structure and includes multiple axially arranged unit waves. The transition section is fixedly connected to the support 2 between adjacent unit waves. The advantage of this design is that during pre-installation, the leak-proof device 1 and the valve sewing section 21 do not overlap, which can minimize the loading tube diameter and reduce the pressure on the artificial valve during loading, thus avoiding damage to the artificial valve. The transition section can be fixed to the support 2 by welding, sewing, or other fixed connection methods.

[0060] In this embodiment, the cross-section of the atrial adaptation segment 13 is elliptical, circular, D-shaped, or saddle-shaped, and the atrial adaptation segment 13 is provided with a plurality of connecting rings 131, which are evenly distributed in the circumferential direction of the atrial adaptation segment 13. The atrial adaptation segment 13 can adapt to the actual shape of the autologous valve annulus in the atrium, so that the anti-leakage device 1 can better fit the autologous tissue and prevent paravalvular leakage after valve prosthesis implantation.

[0061] According to another example of the invention, the delivery system 3 includes a delivery catheter 31, a controllable release device 32, and a valve prosthesis 33, such as Figure 3a As shown, the valve prosthesis 33 includes a leak-proof device 1, a support 2, and an artificial valve 331. The controllable release device 32 is detachably connected to the leak-proof device 1. During pre-installation, the controllable release device 32 and the valve prosthesis 33 are placed inside the delivery catheter 31. When releasing or retrieving the leak-proof device 1, manipulating the controllable release device 32 can cause the leak-proof device 1 to return to a preset shape or a restricted shape along a preset route. When the distal end of the delivery system 3 reaches the target release position, manipulating the controllable release device 32 can cause the leak-proof device 1 to gradually return to the preset shape distally. Ultimately, at least a portion of the transition section, the valve annulus adaptation section 12, and the valve suture section 21 overlap in the axial direction, as shown. Figures 3b-3d As shown.

[0062] In this embodiment, the leak-proof device 1 includes an atrial adaptation section 13, valve annulus adaptation section 12, and transition section 11. When the leak-proof device 1 is in the restricted state, the transition section 11, valve annulus adaptation section 12, and valve suture section 21 are staggered in the axial direction within the delivery catheter 31. The advantage of this design is that it can greatly reduce the loading diameter of the delivery catheter 31, meet the requirements of transvascular access, and cause less damage to the patient's blood vessels. When the leak-proof device 1 returns to the preset state, at least part of the transition section 11, valve annulus adaptation section 12, and valve suture section 21 are overlapped in the axial direction, which allows the leak-proof device 1 to fit tightly against the autologous tissue and has a good leak-proof effect.

[0063] In this embodiment, the center of the leak-proof device 1 does not coincide with the center of the valve suture section 21, such as... Figure 4a As shown, when retrieving the leak-proof device 1, the controllable release device 32 is manipulated so that the portion of the leak-proof device 1 furthest from the center of the valve suture section 21 is pre-retracted into the delivery catheter 31. Since the axial length of the portion of the leak-proof device 1 furthest from the center of the valve suture section 21 is longer when loaded into the delivery catheter 31, retrieving it first, and thus first retrieving the portion of the leak-proof device 1 furthest from the center of the valve suture section 21 into the delivery catheter 31, is more conducive to the complete retrieving of the leak-proof device 1 into the delivery catheter 31. Figure 4b and 4c As shown.

[0064] In this embodiment, the controllable release device 32 includes a control component 321 and a disassembly component 322, such as... Figure 5a and 5bAs shown, the distal end of the control component 321 is provided with a locking ring 3211. During pre-installation, after the locking ring 3211 passes through the connecting ring 131, the distal end of the disassembly component 322 is inserted into the locking ring 3211. When the controllable release device 32 is operated to tighten and lock the control component 321, a connection is formed between the leak-proof device 1, the control component 321, and the disassembly component 322, fixing their relative positions. When the disassembly component 322 is operated to move axially, causing its distal end to disengage from the locking hole, the leak-proof device 1 is released from the control component 321. Figure 5c and 5d As shown.

[0065] The following is an exemplary cardiac atrioventricular tricuspid valve surgery procedure for the valve prosthesis 33 and its delivery system 3 used to prevent paravalvular leakage in this embodiment:

[0066] 1. After the locking ring 3211 at the distal end of the control member 321 passes through the connecting ring 131, the distal end of the disassembly member 322 is inserted into the locking ring 3211 and pulled tight by the control member 321 so that a connection is formed between the leak-proof device 1, the control member 321, and the disassembly member 322, thereby fixing their relative positions.

[0067] 2. The control element 321 is pulled proximally, causing the transition section 11 to fold over. The leak-proof device 1 and the support 2 are pre-installed in the delivery catheter 31. At this time, the transition section 11, the valve annulus adaptation section 12, and the valve suture section 21 are staggered in the axial direction, as shown below. Figure 3a As shown;

[0068] 3. The distal end of the delivery system 3 enters the right atrium through the superior vena cava and moves towards the valve annulus to the target release position. The delivery catheter 31 is withdrawn proximally, and the stent 2 gradually returns to the preset shape. Then, the controllable release device 32 is manipulated to make the leak prevention device 1 return to the preset shape along the preset route until part of the transition section 11, the valve annulus adaptation section 12 and the valve suture section 21 overlap in the axial direction. The valve annulus adaptation section 12 is attached to the autologous valve annulus tissue, and the atrial adaptation section 13 is attached to the atrial tissue.

[0069] 4. Observe the image. If the position of the anti-leakage device 1 is accurate, operate the disassembly component 322 to move axially so that the distal end of the disassembly component 322 disengages from the locking hole, thereby releasing the anti-leakage device 1 from the control component 321. If the position of the anti-leakage device 1 is deviated, operate the control component 321 to move to the proximal end so that the anti-leakage device 1 is retracted into the delivery conduit 31.

[0070] The above content is only a preferred embodiment of this application. For those skilled in the art, there will be changes in the specific implementation and application scope based on the ideas of this application. The content of this specification should not be construed as a limitation of this application.

Claims

1. A valve prosthesis for preventing paravalvular leakage, comprising a leakage prevention device, a stent, said stent comprising a valve sewing segment, a proximal portion of said leakage prevention device and said stent being connected, characterized in that: The anti-leakage device is a special-shaped structure, and has a first shape and a second shape. When the anti-leakage device is in the first shape, the anti-leakage device and the valve sewing section are arranged in an axial direction. When the anti-leakage device is in the second shape, at least part of the anti-leakage device overlaps the valve sewing section in the axial direction. The anti-leakage device comprises a transition section, a valve ring adapting section and an atrium adapting section. The transition section is connected to the proximal end of the stent. The valve ring adapting section is provided with a first protrusion and a second protrusion which are adapted to the shape of the native valve ring. When the anti-leakage device is in the first shape, the first protrusion and the second protrusion are stretched into a linear shape. When the anti-leakage device is converted from the first shape to the second shape, the first protrusion and the second protrusion recover to a preset shape along a preset path and abut the native valve ring tissue. The transition section comprises a first arc-shaped section. The first arc-shaped section is connected to the proximal end of the stent, and the first arc-shaped section is a flexible section. The transition section comprises a second arc-shaped section. The second arc-shaped section is connected to the valve ring adapting section, and the second arc-shaped section has a greater rigidity than the first arc-shaped section.

2. The paravalvular leakage preventing valve prosthesis of claim 1, characterized in that: When the anti-leakage device is converted from the first shape to the second shape, the anti-leakage device recovers to a preset shape along a preset path towards the distal end of the stent.

3. The paravalvular leakage preventing valve prosthesis of claim 1, wherein: When the valve prosthesis is implanted in the heart, the first protrusion and the second protrusion are located in the septal valve region and the posterior valve region of the native valve respectively.

4. The paravalvular leakage preventing valve prosthesis of claim 1, wherein: The rigidity of the valve ring adapting section is greater than the rigidity of the atrium adapting section.

5. The paravalvular leakage preventing valve prosthesis of claim 1, wherein: The stent has a net tube structure, and comprises a plurality of unit waves arranged in an axial direction. The position where the transition section is fixedly connected to the stent is between adjacent unit waves.

6. The paravalvular leakage preventing valve prosthesis of claim 1, wherein: The atrium adapting section has an elliptical, circular, D-shaped or saddle-shaped structure in cross section, and a plurality of connecting rings are arranged on the atrium adapting section.

7. A delivery system of a paravalvular leakage preventing valve prosthesis according to any one of claims 1 to 6, characterized in that: The delivery system comprises a delivery catheter, a controllable release device and a valve prosthesis. The valve prosthesis comprises an anti-leakage device, a stent and an artificial valve. The controllable release device is detachably connected to the anti-leakage device. When the anti-leakage device is released or recovered, the controllable release device is operated to make the anti-leakage device recover to a preset shape or a limited shape along a preset path.

Images