A multi-dimensional fixed heart valve prosthesis

Abstract

The present invention relates to the field of medical devices, and particularly to a multi-dimensionally fixed heart valve prosthesis, which comprises a stent and a valve. The stent includes a valve sewing section and an atrial section. The valve is fixedly connected to the valve sewing section. The valve sewing section is cooperatively connected with the atrial section. A leaflet clamping member is arranged on the valve sewing section, and an anti-disengagement anchoring mechanism is arranged on the atrial section. After the heart valve prosthesis is released, the leaflet clamping member is cooperatively connected with the anterior leaflet of the patient, and the anti-disengagement anchoring mechanism passes through the atrial section and is fixedly connected with the posterior leaflet tissue of the patient. The present invention ingeniously utilizes the physiological and anatomical structure of the heart, sets a leaflet clamping member in the anterior leaflet area for fixing the anterior leaflet, and sets a bi-directional anchoring device in the posterior leaflet area to fix the posterior leaflet area of the patient. The combination of the two enables the valve prosthesis to have multi-dimensional anchoring force, ensuring the anchoring effect of the valve prosthesis in the heart.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and particularly to a multi-dimensionally fixed cardiac valve prosthesis. Background Art

[0002] The mitral valve has a complex anatomical structure, including leaflets, annulus, chordae tendineae, and papillary muscles, which respectively play important roles in maintaining the functions of the left and right ventricles. Any disease that affects the structural integrity and normal function of the leaflets, annulus, chordae tendineae, papillary muscles, and left ventricle may lead to severe mitral regurgitation (MR), which can cause left ventricular failure, pulmonary hypertension, atrial fibrillation, stroke, and death. Mitral regurgitation can be divided into degenerative MR and functional MR. Degenerative MR is caused by pathological changes in one or more of the leaflets, annulus, chordae tendineae, and papillary muscles; functional MR is usually due to abnormal left ventricular function, such as annulus dilation, but the mitral valve is usually normal.

[0003] Currently, the treatment methods for MR mainly include drug therapy, surgical operation, and interventional therapy. Drug therapy can only improve the symptoms of patients and cannot extend their survival time. Surgical operations mainly include valve repair or valve replacement, which is recognized as the preferred treatment method for mitral regurgitation and has been proven to relieve the symptoms of patients and extend their lifespan. However, for many high-risk patients with advanced age and multiple systemic diseases, the surgical risk is high and the survival benefit is small. Therefore, transcatheter mitral valve repair and replacement can theoretically benefit high-risk patients who have lost the opportunity for surgical operation. Interventional therapy is to load an artificial implant onto a delivery system outside the body, deliver it to the mitral annulus along the vascular path or by puncturing the apex of the heart, and then release and fix it to completely or partially replace the function of the autologous valve. Currently, mitral valve interventional therapy has become one of the research hotspots in the related field, and many products are under development. However, due to the complex structure of the mitral valve itself and its surrounding structures, etc., the development of mitral valve interventional devices faces many special difficulties.

[0004] Patent CN201880035165.9 discloses a minimally invasive implantable device and a mitral valve implant system, which includes a device (10) having an annuloplasty ring (11), wherein the annuloplasty ring (11): - has at least one tissue anchor (15); - is deformable between a delivery configuration (57) and an open configuration (X), in the delivery configuration, the annuloplasty ring (11) is compressed to a certain size and inserted into the left atrium (12), in the open configuration, the annuloplasty ring (11) expands to its original initial shape (58) to affect the anatomical opening (9) and is fixed at the anatomical opening; - is generally annular, has an inner layer for stability and at least one outer surrounding layer, and at least one artificial wire (33) is pulled out through the outer surrounding layer; and - has a circular ring body (27), the circular ring body (27); - has a front part (20) that engages the tissue anchor position (24) on the front side (31) of the mitral valve annulus (13) of the anterior leaflet (16), and - has a rear part (21) that engages the tissue anchor position (24) on the rear side (32) of the mitral valve annulus (13) of the posterior leaflet (17), which provides at least one tissue anchor wire (33) from at least one tissue anchor (15) for the tissue anchor position (24) of the annuloplasty ring (11); wherein the tissue anchor (15) can be positioned around the mitral valve annulus (13), and each tissue anchor (15) implanted on the mitral valve annulus (13) is provided with a tissue anchor wire (33) to fix the annuloplasty ring (11) to the tissue anchor (15). The defect of this technical solution is that: according to the physiological and anatomical structure of the mitral valve, the anterior valve region of the mitral valve is close to the aortic region. Therefore, when performing needle insertion in the anterior valve region, the operation difficulty is very high, and it is very easy to puncture the patient's aortic valve region. Moreover, the blood vessel wall in the anterior valve region is very thin and is easily torn after needle insertion, resulting in the failure of the operation; in addition, if only needle insertion and fixation are performed in the posterior valve region, the fixation effect is not ideal enough, and the anterior valve region of the prosthesis will become detached, resulting in the failure of prosthesis fixation.

[0005] Patent CN201410478565.0 discloses a prosthetic device for implantation into the natural mitral valve region of the heart. The natural mitral valve has a natural annulus and anterior and posterior natural valve leaflets. The prosthetic device includes: a radially compressible and self-expandable spacer configured to be placed between the anterior and posterior natural valve leaflets, where the spacer does not allow blood to flow through it; a first ventricular anchor extending from the spacer and configured to be placed behind the anterior natural valve leaflet; and a second ventricular anchor extending from the spacer and configured to be placed behind the posterior natural valve leaflet. This design uses the first and second ventricular anchors to fix the anterior and posterior valve leaflets in the patient's heart respectively. However, the technical defect of this solution is that: according to the physiological and anatomical structure of the mitral valve, the length of the patient's posterior valve leaflet is very short, and its second ventricular anchor cannot effectively clamp and fix the posterior valve leaflet. At the same time, during the actual operation, due to the very short length of the posterior valve leaflet, the difficulty of clamping and anchoring is very high, which will consume a large amount of surgical time. The extension of surgical time is extremely unfavorable for the patient's postoperative recovery and may cause surgical complications. Summary of the Invention

[0006] The object of the present invention is to provide a multi-dimensionally fixed cardiac valve prosthesis, which has the following advantages: Utilizing the physiological and anatomical structure of the heart, a leaflet clamping member is provided in the anterior leaflet region for fixing the anterior leaflet; a bidirectional anchoring device is provided in the posterior leaflet region to fix the patient's posterior leaflet region; the combination of the two enables the valve prosthesis to have multi-dimensional anchoring force, ensuring the anchoring effect of the valve prosthesis in the heart.

[0007] To solve the above technical problems, the present invention is solved by the following technical solutions: A multi-dimensionally fixed cardiac valve prosthesis includes a stent and a valve. The stent includes a valve sewing section and an atrial section. The valve is fixedly connected to the valve sewing section. The valve sewing section is cooperatively connected to the atrial section. A leaflet clamping member is provided on the valve sewing section, and an anti-disengagement anchoring mechanism is provided on the atrial section. When the cardiac valve prosthesis is released, the leaflet clamping member is cooperatively connected to the patient's anterior valve leaflet, and the anti-disengagement anchoring mechanism passes through the atrial section and is fixedly connected to the patient's posterior valve tissue or the anti-disengagement anchoring mechanism passes through the atrial section and is fixedly connected to the patient's posterior valve tissue and the tissue at the junction of the posterior and anterior valve leaflets.

[0008] The present invention can also be further realized by the following technical solutions:

[0009] Preferably, the anti - detachment anchoring mechanism includes an anchoring member and an anti - detachment member. One end of the anchoring member is fixedly connected to one end of the anti - detachment member. The other end of the anchoring member passes through the atrial segment and is cooperatively connected with the cardiac tissue. The other end of the anti - detachment member passes through the atrial segment and then folds back to form two or more connection points with the atrial segment.

[0010] Preferably, the cardiac valve prosthesis further includes a pushing device for the anti - detachment anchoring mechanism. The pushing device for the anti - detachment anchoring mechanism includes a delivery catheter and a push rod. The push rod and the anti - detachment anchoring mechanism are arranged inside the delivery catheter. When the push rod pushes the anti - detachment anchoring mechanism, the other end of the anchoring member passes through the atrial segment and is cooperatively connected with the cardiac tissue. When the push rod is further pushed, the other end of the anti - detachment member passes through the atrial segment and then folds back to form two or more connection points with the atrial segment, and the anti - detachment member restricts the anchoring member from detaching from the atrial segment.

[0011] Preferably, the length of the anchoring member is greater than the length of the anti - detachment member.

[0012] Preferably, both the anchoring member and the anti - detachment member have a preset shape.

[0013] Preferably, the anchoring member is one or more arc - shaped anchoring needles.

[0014] More preferably, the anchoring member can be one or more anchoring needles with a spiral structure.

[0015] Preferably, the anti - detachment member is one or more arc - shaped anchoring needles.

[0016] More preferably, the anti - detachment member can be one or more anchoring needles with a spiral structure.

[0017] More preferably, when the anchoring member is one or more arc - shaped anchoring needles, the anti - detachment member can be one or more arc - shaped anchoring needles.

[0018] More preferably, when the anchoring member is one or more arc - shaped anchoring needles, the anti - detachment member can be one or more anchoring needles with a spiral structure.

[0019] More preferably, when the anchoring member can be one or more anchoring needles with a spiral structure, the anti - detachment member can be one or more arc - shaped anchoring needles.

[0020] More preferably, when the anchoring member can be one or more anchoring needles with a spiral structure, the anti - detachment member can be one or more anchoring needles with a spiral structure.

[0021] Preferably, the atrial segment is covered with a film, and the film material includes metal materials, polytetrafluoroethylene, polyethylene, polypropylene, polyester, or animal - derived materials.

[0022] Preferably, one end of the push rod is detachably connected to the anti - detachment anchoring mechanism.

[0023] More preferably, the other end of the anchoring member passes through the atrial segment and the cardiac tissue and then is connected to the valve sewing segment.

[0024] Preferably, after the other end of the anti - detachment member passes through the atrial segment and the cardiac tissue, it is finally connected to the atrial segment.

[0025] Preferably, the anti - detachment anchoring mechanism further includes a limiting member, and one end of the anchoring member and one end of the anti - detachment member are respectively fixedly connected to the limiting member.

[0026] Preferably, a barbed structure is provided at the end of the other end of the anchoring member or micro - barbs are uniformly arranged on the anchoring member.

[0027] Preferably, a barbed structure is provided at the end of the other end of the anti - detachment member or micro - barbs are uniformly arranged on the anti - detachment member.

[0028] Preferably, the leaflet clamping member includes a fixed end and a free end. The fixed end is cooperatively connected to the valve sewing segment. The free end extends from its fixed end towards the proximal end, passes through a first bending point and then extends towards the distal end to form a leaflet accommodation cavity. When the leaflet clamping member is completely released, the native leaflet is folded and clamped in the leaflet accommodation cavity.

[0029] Compared with the prior art, the advantages of the present invention are as follows:

[0030] 1. The present invention ingeniously utilizes the physiological and anatomical structure of the heart. By using the characteristics that the blood vessel wall in the anterior leaflet area of the mitral valve is very thin, close to the aortic area, and at the same time the anterior leaflet is relatively long, a leaflet clamping member is provided to fold the leaflet of the anterior leaflet and achieve anchoring of the anterior leaflet area; while the posterior leaflet of the mitral valve is not suitable for anchoring by folding the leaflet due to its short length, and because the tissue thickness in the posterior leaflet area of the mitral valve is large, it is very suitable for needle - type anchoring. Therefore, an anti - detachment anchoring mechanism is designed in the posterior leaflet area to anchor the posterior leaflet area; the perfect combination of the two anchoring methods enables the valve prosthesis to have multi - dimensional anchoring force and ensures the anchoring effect of the valve prosthesis in the heart.

[0031] 2. In the present invention, the anchoring member passes through the atrial segment and is cooperatively connected with the cardiac tissue, so that the stent is fixed in the heart. At the same time, after passing through the atrial segment, the anti-disengagement member finally forms two connection points with the atrial segment. Different from the prior art where there is always only one connection point between the anchoring member and the atrial segment, resulting in only one stress point of the anchoring member on the atrial segment. When the stent is impacted by blood flow, the anchoring member is easily disengaged from the atrial segment, causing the stent to lose its fixing point. However, the anti-disengagement member in the present invention has two stress points on the atrial segment. When the stent is impacted by blood flow, the anti-disengagement member can disperse / dissipate the impact force to the two stress points, thereby reducing the stress on the anchoring member and locking the anti-disengagement anchoring mechanism on the atrial segment, avoiding the loosening of the anchoring member relative to the atrial segment and the situation of detachment from the atrial segment.

[0032] 3. The length of the anchoring member in the present invention is greater than that of the anti-disengagement member. The advantage of this design is that the anchoring member fixes the stent to the tissue, and the anti-disengagement member passes through the atrial segment and finally connects with the atrial segment, locking the anti-disengagement anchoring mechanism on the atrial segment. Moreover, the length of the anti-disengagement member is shorter, so it will not hook or compress cardiac tissues such as nerve bundles and coronary sinus during the anchoring / locking process, avoiding damage or tearing of the intracardiac tissues. At the same time, the shorter anti-disengagement member has a smaller moment, is less likely to deform or be pulled off, and can make the locking of the anti-disengagement anchoring mechanism with the atrial segment more stable.

[0033] 4. One end of the push rod in the present invention is detachably connected to the anti-disengagement anchoring mechanism. After the push rod pushes and anchors the anti-disengagement anchoring mechanism to the target position, the push rod can be withdrawn from the human body, greatly reducing the implant and minimizing the contact and irritation to the atrium, facilitating the withdrawal of the delivery system from the human body.

[0034] 5. In the present invention, the anchoring member passes through the atrial segment, through the cardiac tissue and is connected to the valve sewing segment. The purpose of this design is that both ends of the anchoring member are connected to the stent, making the two integrated. After the anchoring member is implanted, it is not easy to loosen relative to the stent, avoiding the situation of the anchoring member being pulled off / detached from the atrial segment.

[0035] 6. In the present invention, the anti-disengagement member passes through the atrial segment and the cardiac tissue and finally connects with the atrial segment. The advantage of this design is that the anti-disengagement member needs to pass through the cardiac tissue and finally connect with the atrial segment, locking the anti-disengagement member on the atrial segment while being connected to some cardiac tissues, further consolidating the anchoring effect of the anti-disengagement member.

[0036] 7. Barbed structures are provided at the other ends of the anchoring member and the anti-disengagement member in the present invention, or micro-barbed structures are evenly distributed on the anchoring member and the anti-disengagement member. The advantage of this design is that it can further enhance the anchoring effect of the anti-disengagement anchoring mechanism and more effectively avoid the situation of the anti-disengagement anchoring mechanism being pulled off / detached from the atrial segment.

[0037] 8. The free end of the leaflet clamping member of the present invention forms a leaflet accommodation cavity. The purpose of this design is that after the native leaflets are folded, they can fill the space of the leaflet accommodation cavity, so that the anchoring force of the leaflet clamping member is greater and the anchoring effect is better. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1 Schematic diagram of the heart valve prosthesis of the present invention passing through the atrioventricular valve.

[0039] Figure 2 Schematic diagram of the retraction of the outer sheath of the present invention.

[0040] Figures 3a - 3e Schematic diagram of the leaflet clamping member of the present invention fixing the anterior leaflet tissue.

[0041] Figures 4a - 4g Schematic diagram of the anti - detachment anchoring mechanism of the present invention fixing the posterior leaflet tissue; wherein Figure 4g is the top view after the anti - detachment anchoring mechanism is fixed.

[0042] Figures 5a - 5c Schematic diagram of the structure after fixation after implantation of the present invention; wherein Figure 5b is Figure 5a a partial enlarged view of Figure 5c for another embodiment.

[0043] Figures 6a - 6n Schematic diagram of various embodiments of the anchoring member structure of the present invention.

[0044] Figure 7a and Figure 7b Schematic diagram of various embodiments of the micro - spines arrangement of the anchoring member of the present invention.

[0045] Figures 8a - 8d Schematic diagram of various embodiments of the atrial segment of the present invention.

[0046] The names of the parts referred to by the numbers in the drawings are as follows: 1 - stent, 11 - valve sewing section, 12 - atrial segment, 2 - leaflet clamping member, 3 - anti - detachment anchoring mechanism, 31 - anchoring member, 32 - anti - detachment member, 33 - anti - detachment anchoring mechanism pushing device, 331 - delivery catheter, 332 - push rod, 34 - limiting member, 21 - fixed end, 22 - free end, 23 - leaflet accommodation cavity. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0047] The present invention will be further described in detail below with reference to the drawings and embodiments.

[0048] In the present invention, the proximal end refers to the end close to the apex of the heart, and the distal end refers to the end far from the apex of the heart. Specific Embodiment

[0049] As Figure 1As shown, a multi-dimensionally fixed heart valve prosthesis includes a stent 1 and a valve (not shown). As Figure 5a shown, the stent 1 includes a valve sewing section 11 and an atrial section 12. The valve (not shown) is fixedly connected to the valve sewing section 11, and the valve sewing section 11 is cooperatively connected with the atrial section 12. As Figures 3a - 3e shown, a leaflet clamping member 2 is provided on the valve sewing section 11, and the leaflet clamping member 2 is cooperatively connected with the anterior leaflet of the patient; As Figure 4g shown, an anti-disengagement anchoring mechanism 3 is provided on the atrial section 12. The anti-disengagement anchoring mechanism 3 passes through the atrial section 12 and is fixedly connected to the posterior leaflet tissue of the patient, or the anti-disengagement anchoring mechanism 3 passes through the atrial section 12 and is fixedly connected to the posterior leaflet tissue of the patient and the tissue at the junction of the posterior leaflet and the anterior leaflet; The anti-disengagement anchoring mechanism 3 includes an anchoring member 31 and an anti-disengagement member 32. One end of the anchoring member 31 is fixedly connected to one end of the anti-disengagement member 32. The other end of the anchoring member 31 passes through the atrial section 12 and is cooperatively connected with the heart tissue. The other end of the anti-disengagement member 32 passes through the atrial section 12 and finally cooperates with the atrial section 12. The anti-disengagement member 32 restricts the anchoring member 31 from disengaging from the atrial section 12; The leaflet clamping member 2 includes a fixed end 21 and a free end 22. The fixed end 21 is cooperatively connected with the valve sewing section 11. The free end 22 extends proximally from its fixed end 21, and after passing through a first bending point, extends distally to form a leaflet receiving cavity 23. When the leaflet clamping member 2 is fully released, the native leaflet is folded and clamped in the leaflet receiving cavity 23; According to the physiological and anatomical structure of the heart, by using the characteristics that the blood vessel wall in the anterior leaflet area of the mitral valve is very thin, close to the aortic area, and at the same time the anterior leaflet is relatively long, the leaflet clamping member 2 is provided to fold the leaflet of the anterior leaflet and achieve anchoring of the anterior leaflet area; However, the posterior leaflet of the mitral valve is not suitable for anchoring by folding the leaflet due to its short length, and because the tissue thickness in the posterior leaflet area of the mitral valve is large, it is very suitable for needle anchoring. Therefore, the anti-disengagement anchoring mechanism 3 is designed in the posterior leaflet area to anchor the posterior leaflet area; The perfect combination of the two anchoring methods enables the valve prosthesis to have multi-dimensional anchoring force and ensures the anchoring effect of the valve prosthesis in the heart.

[0050] Next, the composition and connection method of each component of the reversibly bendable valve delivery system of the present invention will be described in detail with reference to the accompanying drawings;

[0051] In this embodiment, the heart valve prosthesis further includes an anti-disengagement anchoring mechanism pushing device 33. As Figures 4a - 4fAs shown, the anti - detachment anchoring mechanism pushing device 33 includes a delivery catheter 331 and a push rod 332. The push rod 332 and the anti - detachment anchoring mechanism 3 are arranged inside the delivery catheter 331. When the push rod 332 pushes the anti - detachment anchoring mechanism 3, the other end of the anchoring member 31 passes through the atrial segment 12 and is cooperatively connected with the heart tissue. When the push rod 332 is further pushed, the other end of the anti - detachment member 32 passes through the atrial segment 12 and finally forms two connection points with the atrial segment 12 (as shown in Figure 5b ), and the anti - detachment member 32 restricts the anchoring member 31 from detaching from the atrial segment 12.

[0052] In another embodiment, the other end of the anti - detachment member 32 passes through the atrial segment 12, then folds back and forms three connection points with the atrial segment 12 (as shown in Figure 5c ), and the anti - detachment member 32 restricts the anchoring member 31 from detaching from the atrial segment 12.

[0053] In this embodiment, the length of the anchoring member 31 is greater than the length of the anti - detachment member 32. The advantage of this design is that the anchoring member fixes the stent 1 to the tissue, and the anti - detachment member 32 passes through the atrial segment 12 and finally connects with the atrial segment 12, so that the anti - detachment anchoring mechanism 3 is locked on the atrial segment 12. Moreover, since the length of the anti - detachment member is shorter, it will not hook or compress heart tissues such as nerve bundles and coronary sinus during the anchoring / locking process, avoiding damage or tearing of the intracardiac tissues. At the same time, the shorter anti - detachment member 32 has a smaller moment, is less likely to deform or be pulled off, and can make the locking of the anti - detachment anchoring mechanism 3 with the atrial segment 12 more stable. Both the anchoring member 31 and the anti - detachment member 32 have a preset shape.

[0054] In this embodiment, the anchoring member 31 is one or more arc - shaped anchoring needles; or the anchoring member 31 can be one or more anchoring needles with a spiral structure, as shown in Figures 6a - 6f .

[0055] In this embodiment, the anti - detachment member 32 is one or more arc - shaped anchoring needles; or the anti - detachment member 32 can be one or more anchoring needles with a spiral structure, as shown in Figures 6a - 6f .

[0056] In some preferred embodiments, when the anchoring member 31 is one or more arc - shaped anchoring needles, the anti - detachment member 32 can be one or more arc - shaped anchoring needles, as shown in Figures 6a - 6f .

[0057] In some preferred embodiments, when the anchoring member 31 is one or more arc - shaped anchoring needles, the anti - detachment member 32 can be one or more anchoring needles with a spiral structure, as shown in Figures 6a - 6f .

[0058] In some preferred embodiments, when the anchoring member 31 can be one or more anchoring needles in a spiral structure, the anti-disengagement member 32 can be one or more arc-shaped anchoring needles, as Figures 6a - 6f shown.

[0059] In some preferred embodiments, when the anchoring member 31 can be one or more anchoring needles in a spiral structure, the anti-disengagement member 32 can be one or more anchoring needles in a spiral structure, as Figures 6a - 6f shown.

[0060] In some preferred embodiments, the shape of the other end of the anchoring member 31 can be a spiral structure; similarly, the shape of the other end of the anti-disengagement member 32 can also be a spiral structure, as Figure 6g shown. When the shape of the other end of the anti-disengagement member 32 is a spiral structure, the anti-disengagement member 32 and the anchoring region will form 4 connection points, further ensuring that the anti-disengagement member 32 will not disengage from the anchoring region 12. Furthermore, when the valve prosthesis 1 is subjected to blood flow impact, the anti-disengagement member 32 can disperse / dissipate the impact force to these 4 force-bearing points, thereby reducing the force on the anchoring member 31, so that the anti-disengagement and anchoring mechanism 2 is locked on the anchoring region 12, avoiding the situation that the anchoring member 31 loosens relative to the anchoring region 12 and disengages from the anchoring region 12.

[0061] In some preferred embodiments, the anti-disengagement and anchoring mechanism 2 is further provided with a connecting section, as Figure 6h shown. The connecting section is arranged in an arc shape. One end of the anchoring member 31 is connected to the connecting section, and one end of the anti-disengagement member 32 is connected to the connecting section.

[0062] In some preferred embodiments, as Figure 6i and 6j shown, both the anchoring member 31 and the anti-disengagement member 32 have a preset shape; when the anchoring member 31 is one or more arc-shaped anchoring needles, the anti-disengagement member 32 can be one or more arc-shaped anchoring needles.

[0063] In some preferred embodiments, as Figure 6k shown, when the anchoring member 31 is one or more arc-shaped anchoring needles, the anti-disengagement member 32 can be one or more anchoring needles in a spiral structure.

[0064] In some preferred embodiments, as Figure 6l shown, when the anchoring member 31 can be one or more anchoring needles in a spiral structure, the anti-disengagement member 32 can be one or more arc-shaped anchoring needles.

[0065] In some preferred embodiments, as Figure 6m and 6nAs shown, when the anchor 31 can be one or more anchor pins with a spiral structure, the anti-disengagement member 32 can be one or more anchor pins with a spiral structure.

[0066] In this embodiment, the atrial segment 12 is covered with a film, and the film material includes a metal material, polytetrafluoroethylene, polyethylene, polypropylene, polyester, or an animal-derived material.

[0067] As Figure 4b shown, one end of the push rod 332 is detachably connected to the anti-disengagement anchoring mechanism 3; specifically, one end of the push rod 332 is movably connected to the limiting member 34 (the connection method can adopt well-known technologies, such as a rope sleeve, a slipknot, etc.). After confirming that the anchoring effect of the anti-disengagement anchoring mechanism 3 is ideal, the above-mentioned movable connection is removed, and the anti-disengagement anchoring mechanism pushing device 33 (including the delivery catheter 331 and the push rod 332) can be withdrawn from the human body. The advantage of this design is that it can reduce the volume of the implanted object and reduce the risk of thrombus formation.

[0068] In this embodiment, the other end of the anchor 31 passes through the atrial segment 12 and the heart tissue and then is connected to the valve sewing segment 11; more preferably, the other end of the anchor 31 passes through the atrial segment 12, the heart tissue, and the valve sewing segment 11 and is located between the artificial valve and the valve sewing segment 11. The other end of the anti-disengagement member 32 passes through the atrial segment 12 and the heart tissue and finally is connected to the atrial segment 12, as Figure 8a shown; the advantage of this design is that: the anti-disengagement member 32 needs to pass through the heart tissue and finally be connected to the atrial segment 12, so that the anti-disengagement member 32 is locked to the atrial segment 12 and at the same time is connected to part of the heart tissue, further consolidating the anchoring effect of the anti-disengagement member 32; at the same time, both ends of the anchor 31 are connected to the stent 1, so that the two are connected into a whole, and it is not easy to loosen between the anchor 31 and the stent 1 after the anchor 31 is implanted, avoiding the situation that the anchor 31 is pulled off / detached from the atrial segment 12.

[0069] In another embodiment, as Figure 8b shown, the other end of the anchor 31 passes through the atrial segment 12 and the heart tissue and then is connected to the valve sewing segment 11; the other end of the anti-disengagement member 32 passes through the atrial segment 12 and finally is connected to the atrial segment 12 and forms two connection points with the atrial segment 12.

[0070] In another embodiment, as Figure 8c shown, the other end of the anchor 31 passes through the atrial segment 12 and is connected to the patient's heart tissue; the other end of the anti-disengagement member 32 passes through the atrial segment 12 and the heart tissue and finally is connected to the atrial segment 12 and forms two connection points with the atrial segment 12.

[0071] In another embodiment, asFigure 8d As shown, the other end of the anchor 31 passes through the atrial segment 12 and is connected to the patient's heart tissue; the other end of the anti-disengagement member 32 passes through the atrial segment 12, and finally is connected to the atrial segment 12 and forms two connection points with the atrial segment 12.

[0072] In this embodiment, barbs are provided at the end of the other end of the anchor 31 or micro barbs are uniformly arranged on the anchor 31, as Figure 7a and Figure 7b shown; this can further increase the anchoring effect of the anchor 31 and more effectively avoid the situation that the anchor 31 is pulled off / detached from the atrial segment 12.

[0073] In this embodiment, barbs are provided at the end of the other end of the anti-disengagement member 32 or micro barbs are uniformly arranged on the anti-disengagement member 32, as Figure 7a and Figure 7b shown; the advantage of such a design is that it can further increase the locking effect of the anti-disengagement member 32 and more effectively avoid the situation that the anchor 31 is pulled off / detached from the atrial segment 12.

[0074] The working process steps of the present invention are as follows (refer to the attached drawings):

[0075] 1. Insert the delivery catheter 331 equipped with the heart valve prosthesis into the right atrium, pass through the atrial septum and enter the left atrium;

[0076] 2. Remove the outer sheath tube, so that the free end 22 of the leaflet holder 2 extends proximally from its fixed end 21, passes through the first bending point and then extends distally to form a leaflet receiving cavity 23. When the leaflet holder 2 is completely released, the native leaflets are folded and clamped in the leaflet receiving cavity 23;

[0077] 3. Continue to withdraw the outer sheath tube, the valve prosthesis is completely released, and then the anti-disengagement and anchoring mechanism pushing device 33 is used to fix the anti-disengagement and anchoring mechanism 3 in the posterior leaflet area at the right atrium. Specifically, when the push rod 332 pushes the anti-disengagement and anchoring mechanism 3, the other end of the anchor 31 first passes through the atrial segment 12 and is connected to the heart tissue in cooperation. When the push rod 332 is further pushed, the other end of the anti-disengagement member 32 passes through the atrial segment 12 and finally is connected to the atrial segment 12 in cooperation;

[0078] 4. Withdraw the delivery catheter 331 from the human body;

[0079] The above content is only a preferred embodiment of the present invention. For those of ordinary skill in the art, according to the idea of the present invention, there will be changes in the specific implementation manners and application scopes. The content of this specification should not be construed as a limitation to the present invention.

Claims

1. A multi-dimensionally fixed heart valve prosthesis, comprising a stent and a valve, characterized in that: The stent includes a valve sewing section and an atrial section. The valve is fixedly connected to the valve sewing section. The valve sewing section is cooperatively connected with the atrial section. A leaflet clamping member is provided on the valve sewing section, and an anti-disengagement anchoring mechanism is provided on the atrial section. After the heart valve prosthesis is released, the leaflet clamping member is cooperatively connected with the anterior leaflet of the patient. The anti-disengagement anchoring mechanism passes through the atrial section and is fixedly connected to the posterior leaflet tissue of the patient. The anti-disengagement anchoring mechanism includes an anchoring member and an anti-disengagement member. The length of the anchoring member is greater than that of the anti-disengagement member. One end of the anchoring member and one end of the anti-disengagement member are fixedly connected. The other end of the anchoring member passes through the atrial section and the heart tissue and then is connected to the valve sewing section. The other end of the anti-disengagement member passes through the atrial section and the heart tissue and then folds back to form more than two connection points with the atrial section and finally is connected to the atrial section.

2. The multidimensionally fixed heart valve prosthesis according to claim 1, wherein: The heart valve prosthesis further includes an anti-disengagement anchoring mechanism pushing device. The anti-disengagement anchoring mechanism pushing device includes a delivery catheter and a push rod. The push rod and the anti-disengagement anchoring mechanism are arranged in the delivery catheter. When the push rod pushes the anti-disengagement anchoring mechanism, the other end of the anchoring member passes through the atrial section and is cooperatively connected with the heart tissue. When the push rod is further pushed, the other end of the anti-disengagement member passes through the atrial section and then folds back to form more than two connection points with the atrial section. The anti-disengagement member restricts the anchoring member from disengaging from the atrial section.

3. A multi-dimensionally fixed heart valve prosthesis according to claim 1, characterized in that: The anchoring member is one or more arc-shaped anchoring needles, and the anti-disengagement member is one or more arc-shaped anchoring needles.

4. A multi-dimensionally fixed heart valve prosthesis according to claim 2, characterized in that: One end of the push rod is detachably connected to the anti-disengagement anchoring mechanism.

5. A multi-dimensionally fixed heart valve prosthesis according to claim 1, wherein: The atrial section is covered with a film.

6. A multi-dimensionally fixed heart valve prosthesis according to claim 1, characterized in that: The anti-disengagement anchoring mechanism further includes a limiting member. One end of the anchoring member and one end of the anti-disengagement member are respectively fixedly connected to the limiting member.

7. A multi-dimensionally fixed heart valve prosthesis according to claim 1, wherein: The leaflet clamping member includes a fixed end and a free end. The fixed end is cooperatively connected with the valve sewing section. The free end extends from its fixed end to the proximal end, passes through a first bending point and then extends to the distal end to form a leaflet receiving cavity. When the leaflet clamping member is fully released, the native leaflet is folded and clamped in the leaflet receiving cavity.

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