An anti - detachment anchoring mechanism applied to an implant prosthesis

Abstract

The present invention relates to the field of medical devices, and particularly to an anti-disengagement anchoring mechanism applied to an implantable prosthesis; it includes an implantable prosthesis, a pushing device and an anti-disengagement anchoring mechanism. The valve prosthesis includes a valve sewing section and an anchoring area. The anti-disengagement anchoring mechanism includes an anchoring member and an anti-disengagement member. One end of the anchoring member is connected to one end of the anti-disengagement member. The pushing device pushes the anti-disengagement anchoring mechanism, and the other end of the anchoring member passes through the anchoring area and is connected to the heart tissue in a matching manner. When the anti-disengagement anchoring mechanism is further pushed, the other end of the anti-disengagement member passes through the anchoring area and then folds back and finally forms two or more connection points with the anchoring area; in the present invention, the anchoring member passes through the anchoring area and is connected to the heart tissue in a matching manner, so that the stent is fixed in the heart. At the same time, the anti-disengagement member passes through the anchoring area and is finally connected to the anchoring area, so that the anti-disengagement anchoring mechanism is locked on the anchoring area, avoiding the loosening of the anchoring member relative to the anchoring area and the situation of disengaging from the anchoring area.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and particularly to an anti - detachment anchoring mechanism applied to an implantable prosthesis. Background Art

[0002] The mitral valve has a complex anatomical structure, including valve 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 valve 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 valve 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 itself is usually normal.

[0003] Currently, the treatment methods for MR mainly include drug treatment, surgical operation and interventional treatment. Drug treatment can only improve the symptoms of patients and cannot extend their survival time. Surgical operations are mainly valve repair or valve replacement, which are recognized as the preferred treatment methods for mitral regurgitation and have 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 surgery. Interventional treatment 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 treatment has become one of the research hotspots in the related fields, and many products are under development. However, due to problems such as the complexity of the mitral valve itself and its surrounding structures, 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, having an inner layer for stability and at least one outer surrounding layer, through which at least one artificial wire (33) is pulled out; 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). This technical solution uses a "spiral anchor needle" to fix the annuloplasty ring at the annulus position of the mitral valve... With the repeated pulsation of the heart, it is easy for looseness to occur between the "spiral anchor needle" and the annuloplasty ring, resulting in the detachment of the anchor needle from the annuloplasty ring, thereby causing the failure of the implanted prosthesis.

[0005] Patent CN201910354329.0 discloses a device for reducing the opening area of the mitral annulus. The device includes an anchor, a plugging member, and a connecting rope. The anchor is adapted to be connected to the mitral annulus. The plugging member has two discs with a gap therebetween. The two discs are respectively located on both sides of the interatrial septum to connect the plugging member to the interatrial septum. The two ends of the connecting rope are respectively connected to the anchor and the plugging member. By adjusting the distance between the anchor and the plugging member, the opening area of the mitral annulus can be adjusted. The device uses a connecting rope to connect the anchor and the plugging member, and relatively easily realizes the adjustment of the distance between the anchor and the plugging member, and preferably realizes the function of reducing the opening area of the mitral annulus. At the same time, the direct connection of the anchor to the mitral annulus reduces the adverse effects of the device on the vein and improves the safety of using the device. Among them, the anchor used in the technical solution is a commonly used "spiral shape" or "double hook shape". After long-term implantation of the prosthesis, since the anchor is not designed with a structure for further locking to make the anchoring more secure, the pulsation of the heart will cause the anchor to easily detach from the annulus position.

[0006] In summary, although the above-described technical solutions all use the anchor to fix the prosthesis in the patient's heart, since the anchor is not designed with a structure for further locking function to make the anchoring effect more secure, during the continuous pulsation of the heart, the anchor is very easy to detach from the belonging anchoring area, resulting in the prosthesis losing the fixing point. Summary of the Invention

[0007] The purpose of the present invention is to provide an anti-detachment anchoring mechanism applied to an implanted prosthesis. The valve prosthesis has the following advantages: the anchor passes through the anchoring area and is connected with the heart tissue in cooperation, so that the stent is fixed in the heart. At the same time, after the anti-detachment member passes through the anchoring area, it finally connects with the anchoring area, so that the anti-detachment anchoring mechanism is locked on the anchoring area, avoiding the situation that the anchor loosens and detaches from the anchoring area.

[0008] To solve the above technical problems, the present invention is solved by the following technical solutions: an anti-detachment anchoring mechanism applied to an implanted prosthesis, including an implanted prosthesis, a pushing device, and an anti-detachment anchoring mechanism arranged in the pushing device. The anti-detachment anchoring mechanism includes an anchor and an anti-detachment member. One end of the anchor is connected to one end of the anti-detachment member. The pushing device pushes the anti-detachment anchoring mechanism and makes the other end of the anchor pass through the anchoring area and be connected with the heart tissue in cooperation. When further pushing the anti-detachment anchoring mechanism, the other end of the anti-detachment member passes through the anchoring area and then folds back and finally forms two or more connection points with the anchoring area.

[0009] The present invention can also be further realized by the following technical solutions:

[0010] Preferably, the pushing device includes a delivery catheter and a push rod. The push rod and the anti - detachment anchoring mechanism are arranged inside the delivery catheter. The anti - detachment anchoring mechanism is arranged on the distal side of the push rod. The push rod pushes the anti - detachment anchoring mechanism, causing the other end of the anchoring member to pass through the anchoring area and cooperate with the heart tissue for connection. When further pushing the anti - detachment anchoring mechanism, the other end of the anti - detachment member passes through the anchoring area and then folds back, finally forming two or more connection points with the anchoring area.

[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 can be 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 anchoring area is covered with a film, and the film material includes metallic materials, polytetrafluoroethylene, polyethylene, polypropylene, polyester, or animal - derived materials.

[0022] Preferably, the stent further includes an atrial segment, which is arranged at the distal end of the valve sewing segment, and the anchoring area is arranged on the atrial segment.

[0023] In another embodiment, the stent further includes a fixing device, the anchoring region is disposed on the fixing device, and one end of the fixing device is connected to the proximal portion of the valve sewing section.

[0024] Preferably, one end of the push rod is detachably connected to the anti-disengagement anchoring mechanism.

[0025] Preferably, the other end of the anchor passes through the anchoring region and the heart tissue and then is connected to the valve sewing section.

[0026] More preferably, the other end of the anchor passes through the anchoring region, the heart tissue, and the valve sewing section and is located between the artificial valve and the valve sewing section.

[0027] More preferably, the other end of the anti-disengagement member passes through the anchoring region and the heart tissue and finally is connected to the anchoring region.

[0028] Preferably, the anti-disengagement anchoring mechanism further includes a limiting member, and one end of the anchor and one end of the anti-disengagement member are respectively fixedly connected to the limiting member.

[0029] Preferably, barbed structures are provided at the end of the other end of the anchor or micro barbs are uniformly arranged on the anchor.

[0030] Preferably, barbed structures are provided at the end of the other end of the anti-disengagement member or micro barbs are uniformly arranged on the anti-disengagement member.

[0031] Compared with the prior art, the advantages of the present invention are as follows:

[0032] 1. In the present invention, the anchor passes through the anchoring region and is cooperatively connected with the heart tissue, so that the stent is fixed in the heart. At the same time, after the anti-disengagement member passes through the anchoring region, two connection points are finally formed with the anchoring region; different from the prior art in which there is always only one connection point between the anchor and the anchoring region, resulting in only one stress point of the anchor on the anchoring region. When the stent is impacted by blood flow, the anchor is easily disengaged from the anchoring region, leading to the loss of the fixing point of the stent. However, in the present invention, the anti-disengagement member has two or more stress points on the anchoring region. When the stent is impacted by blood flow, the anti-disengagement member can disperse / dissipate the impact force to two or more stress points, thereby reducing the stress on the anchor and locking the anti-disengagement anchoring mechanism on the anchoring region to avoid the loosening of the anchor relative to the anchoring region and the situation of disengagement from the anchoring region;

[0033] 2. The length of the main locking member in the present invention is greater than that of the auxiliary locking member. The advantage of this design is that when it is used for the treatment of mitral valve diseases, the main locking member fixes the stent to the tissue. The anti-disengagement member passes through the anchoring area and finally connects to the anchoring area, so that the anti-disengagement anchoring mechanism is locked on the anchoring area. And the length of the auxiliary locking member is shorter. Therefore, during the anchoring / locking process, it will not hook or compress cardiac tissues such as nerve bundles and coronary sinus, avoiding damage or tearing of 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 to the anchoring area more stable.

[0034] 3. 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, reducing the contact and irritation to the atrium, and facilitating the withdrawal of the delivery system from the human body.

[0035] 4. In the present invention, the anchoring member passes through the anchoring area, through the cardiac tissue and is connected to the valve sewing section. The purpose of this design is that both ends of the anchoring member are connected to the stent, making the two connected as a whole. After the anchoring member is implanted, it is not easy to loosen relative to the stent, avoiding the situation that the anchoring member is pulled off / detached from the anchoring area.

[0036] 5. In the present invention, the auxiliary locking member passes through the anchoring area and the cardiac tissue and finally connects to the anchoring area. The advantage of this design is that the anti-disengagement member needs to pass through the cardiac tissue and finally connect to the anchoring area, so that the anti-disengagement member is locked in the anchoring area and at the same time connected to some cardiac tissues, further consolidating the anchoring effect of the anti-disengagement member.

[0037] 6. Barbed structures are provided at the other ends of the anchoring member and the anti-disengagement member respectively, or micro-barbs are evenly distributed on the anchoring member and the anti-disengagement member. The advantage of this design is that it can further increase the anchoring effect of the anti-disengagement anchoring mechanism and more effectively avoid the situation that the anti-disengagement anchoring mechanism is pulled off / detached from the anchoring area. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figures 1a - 1b is a schematic diagram of the overall structure of the present invention.

[0039] Figures 2a - 2e is a schematic diagram of the process of implanting and anchoring the anti-disengagement anchoring mechanism.

[0040] Figures 3a - 3b is a schematic diagram of the structure of the anchoring member forming a connection point in the anchoring section.

[0041] Figures 4a - 4m is a schematic diagram of the structures of various embodiments of the anti-disengagement anchoring mechanism.

[0042] Figures 5a - 5c Schematic diagrams of various structures for connecting the anti - detachment anchoring mechanism to heart tissue.

[0043] Figures 6a - 6b Schematic diagram of another implementation of the anti - detachment anchoring mechanism.

[0044] Figures 7a - 7e Schematic diagram of the process for another embodiment.

[0045] The names of the parts referred to by each number in the drawings are as follows: 1 - stent, 11 - valve sewing section, 12 - atrial section, 13 - anchoring area, 2 - anti - detachment anchoring mechanism, 21 - anchor, 22 - anti - detachment part, 3 - anti - detachment anchoring mechanism pushing device, 31 - delivery catheter, 32 - push rod, 4 - limiting part, 5 - barb structure, 6 - micro - barb, 7 - fixing device. Detailed implementation manners

[0046] The present invention will be further described in detail below in conjunction with the drawings and embodiments.

[0047] 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 1:

[0049] When used for the treatment of mitral valve diseases, as Figure 1a and Figure 1b shown, an anti - detachment anchoring mechanism applied to an implantable prosthesis includes a valve prosthesis 1, a pushing device 3, and an anti - detachment anchoring mechanism 2 disposed within the pushing device 3. The valve prosthesis 1 includes a valve sewing section 11, an atrial section 12, and an anchoring area 13. The atrial section 12 is disposed at the distal end of the valve sewing section 11, and the anchoring area 13 is disposed on the atrial section 12. The anti - detachment anchoring mechanism 2 is disposed on the anchoring area 13. The anti - detachment anchoring mechanism 2 includes an anchor 21 and an anti - detachment part 22. One end of the anchor 21 and one end of the anti - detachment part 22 are fixedly connected. As Figures 2a - 2e shown, the push rod 32 located within the delivery catheter 31 pushes the anti - detachment anchoring mechanism 2 such that the other end of the anchor 21 passes through the anchoring area 13 and cooperates with the heart tissue for connection. Further pushing the anti - detachment anchoring mechanism 2; as Figure 3a shown, the other end of the anti - detachment part 22 passes through the anchoring area 13 and then folds back and finally forms two connection points with the anchoring area 13. The anti - detachment part 22 restricts the anchor 21 from detaching from the anchoring area 13; the anchor 21 passes through the anchoring area 13 and cooperates with the heart tissue for connection, so that the stent 1 is fixed in the heart. At the same time, the anti - detachment part 22 finally connects with the anchoring area 13 after passing through the anchoring area 13, so that the anti - detachment anchoring mechanism 2 is locked on the anchoring area 13, avoiding the situation that the anchor 21 loosens relative to the anchoring area 13 and detaches from the anchoring area 13.

[0050] The composition and connection mode of each component of the reversibly bendable valve delivery system of the present invention will be described in detail below in conjunction with the accompanying drawings;

[0051] In this embodiment, as Figure 1b shown, the valve prosthesis further includes a pushing device 3. The pushing device 3 includes a delivery catheter 31 and a push rod 32. The push rod 32 and the anti-disengagement anchoring mechanism 2 are arranged in the delivery catheter 31. The anti-disengagement anchoring mechanism 2 is arranged on the distal side of the push rod 32. When the push rod 32 pushes the anti-disengagement anchoring mechanism 2, the other end of the anchoring member 21 passes through the anchoring area 13 and is connected with the heart tissue in a matching manner. When the push rod 32 is further pushed, the other end of the anti-disengagement member 22 passes through the anchoring area 13 and finally is connected with the anchoring area 13 in a matching manner. The anti-disengagement member 22 restricts the anchoring member 21 from disengaging from the anchoring area 13.

[0052] In another preferred embodiment, the pushing device 3 pushes the anti-disengagement anchoring mechanism 2 and makes the other end of the anchoring member 21 pass through the anchoring area 13 and be connected with the heart tissue in a matching manner. When the anti-disengagement anchoring mechanism 2 is further pushed; as Figure 3b shown, the other end of the anti-disengagement member 22 passes through the anchoring area 13 and then folds back and finally forms three connection points with the anchoring area 13. The anti-disengagement member 22 restricts the anchoring member 21 from disengaging from the anchoring area 13.

[0053] In this embodiment, the anchoring area 13 is covered with a film, and the film material includes a metal material, polytetrafluoroethylene, polyethylene, polypropylene, polyester or an animal-derived material.

[0054] In this embodiment, the length of the anchoring member 21 is greater than the length of the anti-disengagement member 22; the advantage of such a design is that the main locking member fixes the stent 1 to the tissue. The anti-disengagement member 22 passes through the anchoring area 13 and finally is connected with the anchoring area 13, so that the anti-disengagement anchoring mechanism 2 is locked on the anchoring area 13. Moreover, the length of the auxiliary locking member is shorter. Therefore, during the anchoring / locking process, it will not hook or compress heart tissues such as nerve bundles and coronary sinus, avoiding damage or tearing of the intracardiac tissues; at the same time, the shorter anti-disengagement member 22 has a smaller moment and is less likely to deform or be pulled off, which can make the locking of the anti-disengagement anchoring mechanism 2 and the anchoring area 13 more stable.

[0055] In this embodiment, the shape of the other end of the anchoring member 21 can be a spiral structure; similarly, the shape of the other end of the anti-disengagement member 22 can also be a spiral structure, as Figure 4aAs shown, when the other end of the anti-disengagement member 22 is in a spiral structure, the anti-disengagement member 22 and the anchoring region will form 4 connection points, further ensuring that the anti-disengagement member 22 will not disengage from the anchoring region 13. Furthermore, when the valve prosthesis 1 is impacted by blood flow, the anti-disengagement member 22 can disperse / dissipate the impact force to these 4 stress points, thereby reducing the stress on the anchoring member 21, locking the anti-disengagement and anchoring mechanism 2 on the anchoring region 13, and avoiding the loosening of the anchoring member 21 relative to the anchoring region 13 and the situation of disengaging from the anchoring region 13.

[0056] In another embodiment, a plurality of sharp portions may be provided at the other end of the anti-disengagement member 22, such as Figure 4b As shown, the other end of the anti-disengagement member 22 passes through the anchoring region 13 and then folds back to finally form a plurality of connection points with the anchoring region 13.

[0057] In another embodiment, the anti-disengagement and anchoring mechanism 2 is further provided with a connecting section, such as Figure 4c As shown, the connecting section is arranged in an arc structure. One end of the anchoring member 21 is connected to the connecting section, and one end of the anti-disengagement member 22 is connected to the connecting section.

[0058] In this embodiment, as Figure 4d and 4e shown, the anchoring member 21 and the anti-disengagement member 22 both have a preset shape; when the anchoring member 21 is one or more arc-shaped anchoring needles, the anti-disengagement member 22 can be one or more arc-shaped anchoring needles.

[0059] In another embodiment, as Figure 4f shown, when the anchoring member 21 is one or more arc-shaped anchoring needles, the anti-disengagement member 22 can be one or more anchoring needles with a spiral structure.

[0060] In another embodiment, as Figure 4g shown, when the anchoring member 21 can be one or more anchoring needles with a spiral structure, the anti-disengagement member 22 can be one or more arc-shaped anchoring needles.

[0061] In another embodiment, as Figure 4h and 4i shown, when the anchoring member 21 can be one or more anchoring needles with a spiral structure, the anti-disengagement member 22 can be one or more anchoring needles with a spiral structure.

[0062] In another embodiment, the anti-disengagement and anchoring mechanism 2 further includes a limiting member 4, such as Figures 4j - 4m shown, one end of the anchoring member 21 and one end of the anti-disengagement member 22 are respectively fixedly connected to the limiting member 4.

[0063] In this embodiment, one end of the push rod 32 is detachably connected to the anti - detachment anchoring mechanism 2; specifically, one end of the push rod 32 is movably connected to the limiting member 4 (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 - detachment anchoring mechanism 2 is ideal, the above - mentioned movable connection is removed, and then the pushing device 3 (including the delivery catheter 31 and the push rod 32) can be withdrawn from the human body. The advantage of such a design is that it can reduce the volume of the implant and lower the risk of thrombus formation.

[0064] In this embodiment, as Figure 5c shown, the other end of the anchoring member 21 passes through the anchoring area 13, the heart tissue and then is connected to the valve sewing section 11; more preferably, the other end of the anchoring member 21 passes through the anchoring area 13, the heart tissue, the valve sewing section 11 and is located between the artificial valve (not shown) and the valve sewing section 11; the purpose of such a design is that both ends of the anchoring member 21 are connected to the stent 1, making the two connected as a whole. After the anchoring member 21 is implanted, it is not easy to loosen relative to the stent 1, avoiding the situation that the anchoring member 21 is pulled off / detached from the anchoring area 13.

[0065] In this embodiment, as Figure 5a shown, the other end of the anti - detachment member 22 passes through the anchoring area 13, the heart tissue and finally is connected to the anchoring area 13; the advantage of such a design is that the anti - detachment member 22 needs to pass through the heart tissue and finally be connected to the anchoring area 13, so that the anti - detachment member 22 is locked in the anchoring area 13 and is connected to part of the heart tissue at the same time, further consolidating the anchoring effect of the anti - detachment member 22; similarly, as Figure 5b shown, the other end of the anchoring member 21 can pass through the anchoring area 13, the heart tissue, the valve sewing section 11 and be located between the artificial valve (not shown) and the valve sewing section 11, and the other end of the anti - detachment member 22 passes through the anchoring area 13, the heart tissue and finally is connected to the anchoring area 13.

[0066] In this embodiment, as Figure 6a shown, barbed structures 5 are arranged at the end of the other end of the anchoring member 21 or micro - barbs 6 are evenly arranged on the anchoring member 21; this can further increase the anchoring effect of the anchoring member 21 and more effectively avoid the situation that the anchoring member 21 is pulled off / detached from the anchoring area 13.

[0067] In this embodiment, as Figure 6b shown, barbed structures 5 are arranged at the end of the other end of the anti - detachment member 22 or micro - barbs 6 are evenly arranged on the anti - detachment member 22; the advantage of such a design is that it can further increase the locking effect of the anti - detachment member 22 and more effectively avoid the situation that the anchoring member 21 is pulled off / detached from the anchoring area 13. Specific Embodiment Two:

[0069] When used for the treatment of tricuspid valve diseases, such as Figures 7a - 7e shown, an anti - detachment anchoring mechanism applied to an implantable prosthesis includes a stent 1 and an artificial valve (not shown). The stent 1 includes a valve sewing section 11, a fixing device 7, and an anchoring area 13. The anchoring area 13 is arranged on the fixing device 7. An anti - detachment anchoring mechanism 2 is arranged on the anchoring area 13. One end of the fixing device 7 is connected to the proximal part of the valve sewing section 11, and the other end of the fixing device 7 is close to the position of the patient's ventricular septum. The fixing device 7 is fixed on the patient's ventricular septum through the anti - detachment anchoring mechanism 2 and restricts the axial movement of the valve prosthesis. The anti - detachment anchoring mechanism 2 includes an anchoring member 21 and an anti - detachment member 22. One end of the anchoring member 21 is fixedly connected to one end of the anti - detachment member 22. The other end of the anchoring member 21 passes through the anchoring area 13 and is connected to the heart tissue in a matching manner. The other end of the anti - detachment member 22 passes through the anchoring area 13 and then folds back and finally forms two connection points with the anchoring area 13. The anti - detachment member 22 restricts the anchoring member 21 from detaching from the anchoring area 13; the anchoring member 21 passes through the anchoring area 13 and is connected to the heart tissue in a matching manner, so that the stent 1 is fixed in the heart. At the same time, the anti - detachment member 22 passes through the anchoring area 13 and finally is connected to the anchoring area 13, so that the anti - detachment anchoring mechanism 2 is locked on the anchoring area 13, avoiding the loosening of the anchoring member 21 relative to the anchoring area 13 and the situation of detaching from the anchoring area 13.

[0070] In this embodiment, the valve prosthesis further includes a pushing device 3. The pushing device 3 includes a delivery catheter 31 and a push rod 32. The push rod 32 and the anti - detachment anchoring mechanism 2 are arranged in the delivery catheter 31. When the push rod 32 pushes the anti - detachment anchoring mechanism 2, the other end of the anchoring member 21 passes through the anchoring area 13 and is connected to the heart tissue in a matching manner. When the push rod 32 is further pushed, the other end of the anti - detachment member 22 passes through the anchoring area 13 and finally is connected to the anchoring area 13 in a matching manner. The anti - detachment member 22 restricts the anchoring member 21 from detaching from the anchoring area 13.

[0071] In this embodiment, the length of the anchoring member 21 is greater than the length of the anti - detachment member 22; the advantage of such a design is that the main locking member fixes the stent 1 to the tissue. The anti - detachment member 22 passes through the anchoring area 13 and finally is connected to the anchoring area 13, so that the anti - detachment anchoring mechanism 2 is locked on the anchoring area 13. And the length of the auxiliary locking member is shorter. Therefore, during the anchoring / locking process, it will not affect other heart tissues, avoiding the situation of damaging or tearing the intracardiac tissues; at the same time, the shorter anti - detachment member 22 has a smaller moment, is less likely to deform and be pulled off, and can make the locking of the anti - detachment anchoring mechanism 2 and the anchoring area 13 more stable.

[0072] In this embodiment, both the anchoring member 21 and the anti - detachment member 22 have a preset shape; when the anchoring member 21 is one or more arc - shaped anchoring needles, the anti - detachment member 22 can be one or more arc - shaped anchoring needles.

[0073] In another embodiment, when the anchoring member 21 is one or more arc - shaped anchoring needles, the anti - detachment member 22 can be one or more anchoring needles with a spiral structure.

[0074] In another embodiment, when the anchoring member 21 can be one or more anchoring needles with a spiral structure, the anti - detachment member 22 can be one or more arc - shaped anchoring needles.

[0075] In another embodiment, when the anchoring member 21 can be one or more anchoring needles with a spiral structure, the anti - detachment member 22 can be one or more anchoring needles with a spiral structure.

[0076] In this embodiment, the anti - detachment anchoring mechanism 2 further includes a limiting member 4, and one end of the anchoring member 21 and one end of the anti - detachment member 22 are respectively fixedly connected to the limiting member 4.

[0077] In this embodiment, one end of the push rod 32 is detachably connected to the anti - detachment anchoring mechanism 2; specifically, one end of the push rod 32 and the limiting member 4 are movably connected (the connection method can adopt well - known techniques, such as a rope sleeve, a slipknot, etc.). After confirming that the anchoring effect of the anti - detachment anchoring mechanism 2 is ideal, the above - mentioned movable connection is removed, and then the pushing device 3 (including the delivery catheter 31 and the push rod 32) can be withdrawn from the human body. The advantage of such a design is that it can reduce the implant volume and lower the risk of thrombus formation.

[0078] In this embodiment, a barbed structure 5 is provided at the end of the other end of the anchoring member 21 or micro - barbs 6 are uniformly arranged on the anchoring member 21; this can further increase the anchoring effect of the anchoring member 21 and more effectively avoid the situation that the anchoring member 21 is pulled out / detached from the anchoring area 13.

[0079] In this embodiment, a barbed structure 5 is provided at the end of the other end of the anti - detachment member 22 or micro - barbs 6 are uniformly arranged on the anti - detachment member 22; the advantage of such a design is that it can further increase the locking effect of the anti - detachment member 22 and more effectively avoid the situation that the anchoring member 21 is pulled out / detached from the anchoring area 13.

[0080] It should be noted that the anti - detachment anchoring mechanism of the present invention can be applied not only in the field of heart valve prostheses, but also on other implantable prostheses that require an anchoring mechanism / anchoring device; for example, in a occluder used to occlude a defect in the heart or blood vessel, the anti - detachment anchoring mechanism can be anchored on the occluder head, so that the occluder can fit the heart tissue better and further improve the occlusion effect of the occluder.

[0081] 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 manner and application scope. The content of this specification should not be construed as a limitation to the present invention.

Claims

1. An anti - detachment anchoring mechanism applied to an implantable prosthesis, Characterized in that: It includes an implantable prosthesis, an anchoring area arranged on the implantable prosthesis, a pushing device and an anti - detachment anchoring mechanism arranged in the pushing device. The anti - detachment anchoring mechanism includes an anchoring member, an anti - detachment member and a limiting member. One end of the anchoring member and one end of the anti - detachment member are respectively fixedly connected to the limiting member. The pushing device pushes the anti - detachment anchoring mechanism and makes the other end of the anchoring member pass through the anchoring area and the heart tissue and then connect to the valve sewing section of the implantable prosthesis. When further pushing the anti - detachment anchoring mechanism, the other end of the anti - detachment member passes through the anchoring area and the heart tissue and then folds back and finally forms more than two connection points with the anchoring area; the length of the anchoring member is greater than the length of the anti - detachment member.

2. The anti - detachment anchoring mechanism applied to an implantable prosthesis according to claim 1, Characterized in that: The anchoring member is one or more arc - shaped anchoring needles, and the anti - detachment member is one or more arc - shaped anchoring needles.

3. The anti - detachment anchoring mechanism applied to an implantable prosthesis according to claim 1, Characterized in that: The anchoring area is covered with a film.

4. The anti - detachment anchoring mechanism applied to an implantable prosthesis according to claim 1, Characterized in that: The end of the other end of the anchoring member is provided with a barbed structure or micro - barbs are evenly arranged on the anchoring member, or the end of the other end of the anti - detachment member is provided with a barbed structure or micro - barbs are evenly arranged on the anti - detachment member.

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