WO2022042478A1

WO2022042478A1 - Anti-detachment anchoring mechanism applied to implanted prosthesis

Info

Publication number: WO2022042478A1
Application number: PCT/CN2021/114062
Authority: WO
Inventors: 吕世文; 陈志�; 陶永昶; 陈进雄
Original assignee: 宁波健世生物科技有限公司
Priority date: 2020-08-31
Filing date: 2021-08-23
Publication date: 2022-03-03
Also published as: CN212490265U

Abstract

An anti-detachment anchoring mechanism (2) applied to a valve prosthesis (1), comprising a valve prosthesis (1), a pushing device (3), and an anti-detachment anchoring mechanism (2); the valve prosthesis (1) comprises a valve stitching section (11) and an anchoring area (13); the anti-detachment anchoring mechanism (2) comprises an anchoring member (21) and an anti-detachment member (22), one end of the anchoring member (21) being connected to one end of the anti-detachment member (22); the pushing device (3) pushes the anti-detachment anchoring mechanism (2) and enables the other end of the anchoring member (21) to pass through the anchoring area (13) and cooperatively connect to the heart tissue; when the anti-detachment anchoring mechanism (2) is further pushed, the other end of the anti-detachment member (22) passes through the anchoring area (13) and then folds back and finally forms two or more connection points with the anchoring area (13); the anchoring member (21) passes through the anchoring area (13) to cooperatively connect to the heart tissue, so that the valve prosthesis (1) is fixed within the heart; meanwhile, the anti-detachment member (22) passes through the anchoring area (13) and then is finally connected to the anchoring area (13), so that the anti-detachment anchoring mechanism (2) is locked in the anchoring area (13), preventing the situation in which the anchoring member (21) loosens relative to the anchoring area (13) and detaches from the anchoring area (13).

Description

An anti-drop anchoring mechanism applied to implanted prostheses

This application claims the priority of the Chinese utility model patent application "A kind of anti-dropping anchoring mechanism applied to implanted prosthesis" with the application number CN202021856849.6 filed in China on August 31, 2020. The Chinese application The entire contents of is incorporated herein by reference.

technical field

The invention relates to the field of medical devices, in particular to an anti-dropping anchoring mechanism applied to an implanted prosthesis.

Background technique

The anatomical structure of the mitral valve is complex, including leaflets, annulus, chordae tendineae and papillary muscles, which play an important role in the maintenance of left and right ventricular function, respectively. Any structurally intact and functional disorder affecting the valve leaflets, annulus, chordae tendineae, papillary muscles, and left ventricle can lead to severe mitral regurgitation (MR), which can lead to left ventricular failure, pulmonary hypertension , atrial fibrillation, stroke and death. According to the latest epidemiological survey data from the United States and other western developed countries, mitral regurgitation is the type of valvular disease with the highest incidence in the elderly over 65 years old. At present, although there is no authoritative epidemiological survey data in my country, with the advent of the aging population, there is no doubt that the number of mitral valve regurgitation patients in my country is huge. 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, valve annulus, chordae tendineae and papillary muscles; functional MR is usually left ventricular function Abnormalities, such as annulus enlargement, but the mitral valve is usually normal.

At present, the treatment methods of MR mainly include drug therapy, surgery and interventional therapy. Drug treatment can only improve the patient's symptoms, but cannot prolong the patient's survival time. Surgery, primarily valve repair or valve replacement, is recognized as the treatment of choice for mitral regurgitation and has been shown to relieve symptoms and prolong life. However, for many elderly high-risk patients with multisystem disease, the surgical risk is high and the survival benefit is low. According to European data, the surgical success rate of such patients is only 50%, and the surgical success rate of patients with severe functional MR is even higher. as low as 16%. Therefore, transcatheter interventional mitral valve repair and replacement could theoretically benefit high-risk patients who have lost the opportunity for surgery. Interventional therapy is to load the artificial implant on the delivery system in vitro, along the vascular path or puncture the apex to deliver the mitral valve annulus, and then release and fix it to completely or partially replace the function of the native valve. At present, mitral valve interventional therapy has become one of the research hotspots in related fields, and many products are under research and development. However, due to the complex structure of the mitral valve itself and its surrounding structure, the development of mitral valve interventional devices faces many special difficulties.

Patent CN201880035165.9 discloses a minimally invasive implantable device and a mitral valve implant system, comprising 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 which the annuloplasty ring (11) is compressed to sized and inserted into the left atrium (12), in the open configuration, the annuloplasty ring (11) is expanded to its original initial shape (58) to impact the anatomical opening (9) and is secured at the anatomical opening ; - generally annular, having an inner layer for stabilization and at least one outer envelope through which at least one artificial thread (33) is drawn; and - having a circular ring body (27), said circular annulus (27);- having an anterior portion (20) engaging the tissue anchor position (24) of the anterior side (31) of the mitral valve annulus (13) of the anterior leaflet (16), and- Tissue anchor location (24) of the posterior side (32) of the mitral valve annulus (13) having a posterior portion (21) engaging the posterior leaflet (17), which is the tissue anchor location of the annuloplasty ring (11) (24) providing at least one tissue anchor wire (33) from at least one tissue anchor (15); wherein the tissue anchors (15) are positionable around the mitral valve annulus (13) and each implanted in the mitral valve annulus The tissue anchor (15) on (13) is provided with a tissue anchor wire (33) to secure the annuloplasty ring (11) to the tissue anchor (15). This technical solution uses a "spiral anchoring needle" to fix the annuloplasty ring at the annulus position of the mitral valve... And with the repeated beating of the heart, the "spiral anchoring needle" and the annuloplasty The rings are prone to loosening, causing the anchoring pin to fall off the annuloplasty ring, resulting in failure of the implanted prosthesis.

Patent CN201910354329.0 discloses a device for reducing the opening area of the mitral valve annulus. The device includes an anchoring member, a blocking member and a connecting rope. The anchoring member is adapted to be connected with the mitral valve annulus. The blocking member It has two discs, there is a gap between the two discs, and the two discs are located on both sides of the interatrial septum, so as to realize the connection between the blocking piece and the interatrial septum, and the two ends of the connecting rope are respectively connected to the anchor piece and the blocking piece. The connection is made by adjusting the distance between the anchor and the occluder, so as to adjust the opening area of the mitral valve annulus. The device uses a connecting rope to connect the anchoring piece and the blocking piece, so that the distance between the anchoring piece and the blocking piece can be adjusted easily, and the function of reducing the opening area of the mitral valve annulus is better achieved. At the same time, the direct connection of the anchoring piece on the mitral valve annulus reduces the adverse effect of the device on the vein and improves the safety of the device in use. Among them, the anchors used in the technical solution are commonly used "spiral" or "double hook", and after long-term implantation of the prosthesis, the anchors are not designed to further lock the structure to make the anchoring more reliable. , the beating of the heart can easily disengage the anchor from the annulus.

To sum up, although the anchors are used to fix the prosthesis in the patient's heart in the technical solutions described above, since the anchors are not designed with a further locking function to make the anchoring effect more reliable, Therefore, in the process of continuous beating of the heart, the anchoring piece is easily detached from the anchoring area to which it belongs, resulting in the loss of the fixation point of the prosthesis.

SUMMARY OF THE INVENTION

The purpose of the present invention is to provide an anti-detachment anchoring mechanism applied to an implanted prosthesis, and the valve prosthesis has the following advantages: the anchoring member passes through the anchoring area and is connected with the cardiac tissue, so that the stent is fixed in the heart At the same time, after passing through the anchoring area, the anti-detachment piece is finally connected to the anchoring area, so that the anti-detachment anchoring mechanism is locked on the anchoring area, so as to prevent the anchoring piece from loosening and detaching from the anchoring area;

In order to solve the above technical problems, the present invention is solved by the following technical solutions: an anti-dropping anchoring mechanism applied to an implanted prosthesis, comprising an implanted prosthesis, a pushing device and an anti-dropping anchor arranged in the pushing device An anchoring mechanism, the anti-dropping anchoring mechanism includes an anchor piece and an anti-dropping piece, one end of the anchor piece is connected with one end of the anti-dropping piece, and the pushing device pushes the anti-dropping anchoring mechanism and makes the anchor The other end of the fixing piece passes through the anchoring area and is matched with the heart tissue, and when the anti-dropping anchoring mechanism is further pushed, the other end of the anti-dropping piece passes through the anchoring area and then folds back and finally connects with the heart tissue. The anchor regions form two or more attachment points.

The present invention can also be further realized through the following technical solutions:

Preferably, the pushing device includes a delivery catheter and a push rod, the push rod and the anti-detachment anchoring mechanism are arranged in the delivery catheter, and the anti-detachment anchoring mechanism is arranged on the side of the push rod. At the distal end, the push rod pushes the anti-detachment anchoring mechanism and makes the other end of the anchor pass through the anchoring area and is connected with the heart tissue, and when the push rod further pushes the anti-detachment anchoring mechanism , the other end of the anti-falling piece passes through the anchoring area and then folds back and finally forms two or more connection points with the anchoring area.

Preferably, the length of the anchoring member is greater than the length of the anti-falling member.

Preferably, both the anchoring member and the anti-falling member have a predetermined shape.

Preferably, the anchors are one or more arcuate anchoring needles.

More preferably, the anchoring member may be one or more anchoring needles in a helical structure.

Preferably, the anti-falling element can be one or more arc-shaped anchoring needles.

More preferably, the anti-shedding member may be one or more anchoring needles in a helical structure.

More preferably, when the anchoring member is one or more arc-shaped anchoring needles, the anti-dropping member may be one or more arc-shaped anchoring needles.

More preferably, when the anchoring member is one or more arc-shaped anchoring needles, the anti-dropping member may be one or more anchoring needles of helical structure.

More preferably, when the anchoring member can be one or more anchoring needles of helical structure, the anti-dropping member can be one or more arc-shaped anchoring needles.

More preferably, when the anchoring member can be one or more anchoring needles with a helical structure, the anti-dropping member can be one or more anchoring needles with a helical structure.

Preferably, the anchoring region is covered with a film, and the film material includes metal material, polytetrafluoroethylene, polyethylene, polypropylene, polyester or animal-derived material.

Preferably, the stent further comprises an atrial segment disposed distally of the valve suture segment, and the anchoring region is disposed on the atrial segment.

In another embodiment, the stent further comprises a fixation device on which the anchoring region is disposed, and one end of the fixation device is connected to the proximal end portion of the valve suture segment.

Preferably, one end of the push rod is detachably connected to the anti-dropping anchoring mechanism.

Preferably, the other end of the anchoring member is connected to the valve suture segment after passing through the anchoring region and the cardiac tissue.

More preferably, the other end of the anchor passes through the anchoring region, the heart tissue, behind the valve sewing segment and is between the prosthetic valve and the valve sewing segment.

More preferably, after passing through the anchoring region and the cardiac tissue, the other end of the anti-falling element is finally connected to the anchoring region.

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

Preferably, the end of the other end of the anchoring member is provided with a barb structure or the anchoring member is evenly provided with micro-thorns.

Preferably, the end of the other end of the anti-dropping member is provided with a barb structure or the anti-dropping member is evenly provided with micro-thorns.

Compared with the prior art, the advantages of the present invention are:

1. The anchoring member in the present invention is connected with the heart tissue through the anchoring area, so that the stent is fixed in the heart, and at the same time, after the anti-dropping member passes through the anchoring area, it finally forms two connection points with the anchoring area; In the prior art, there is always only one connection point between the anchor and the anchor area, so that the anchor has only one point of force on the anchor area. When the stent is impacted by blood flow, the anchor can easily escape from the anchor area. Therefore, the stent loses its fixed point, and the anti-detachment member of the present invention has two or more stress points on the anchoring area, so that when the stent is impacted by blood flow, the anti-detachment member can disperse/dissolve the impact force. to 2 or more stress points, thereby reducing the stress of the anchor, so that the anti-drop anchor mechanism is locked on the anchor area, preventing the anchor from loosening relative to the anchor area and from the anchor area. disengagement;

2. The length of the main locking piece in the present invention is greater than the length of the auxiliary locking piece. The advantage of this design is that: when it is used for the treatment of mitral valve disease, the main locking piece fixes the stent and the tissue, and the anti-dropping piece passes through the anchor. The anchoring area is finally connected with the anchoring area, so that the anti-detachment anchoring mechanism is locked on the anchoring area, and the length of the auxiliary locking member is short, so it will not hook or compress the nerve bundle during the anchoring/locking process. Coronary venous sinus and other cardiac tissues, avoiding damage or tearing of intracardiac tissues; at the same time, the shorter anti-dropping parts have smaller torque, and are less prone to deformation and pull-off, which can make the anti-dropping anchoring mechanism and anchoring The locking of the area is more stable;

3. One end of the push rod in the present invention is detachably connected to the anti-dropping anchoring mechanism. When the push rod pushes and anchors the anti-dropping anchoring mechanism to the target position, the push rod can be evacuated from the human body, which greatly reduces the Implants that reduce contact and stimulation of the atrium and facilitate the evacuation of the delivery system from the body;

4. In the present invention, the anchoring piece passes through the anchoring area, passes through the heart tissue and is connected with the valve suture segment. The purpose of this design is: both ends of the anchoring piece are connected with the stent, so that the two are connected to each other. As a whole, it is not easy to loosen between the relative stents after the anchors are implanted, so as to avoid the pull-off/detachment of the anchors from the anchoring area;

5. In the present invention, the auxiliary locking member is finally connected to the anchoring area after passing through the anchoring area and the heart tissue. The advantage of this design is that the anti-dropping member needs to pass through the heart tissue and finally connect to the anchoring area, so that the anti-dropping member needs to pass through the heart tissue and finally connect to the anchoring area. While locked in the anchoring area, it is connected with part of the heart tissue, further consolidating the anchoring effect of the anti-dropping piece;

6. In the present invention, the other end of the anchoring piece and the other end of the anti-dropping piece are both provided with a barb structure or the anchoring piece and the other end of the anti-dropping piece are evenly provided with a micro-thorn structure. The anchoring effect of the de-anchoring mechanism can more effectively avoid the pull-off/detachment of the anti-detachment anchoring mechanism from the anchoring area.

Description of drawings

1a-1b are schematic diagrams of the overall structure of the present invention.

Figures 2a-2e are schematic diagrams of the process of implanting the anchorage by the anti-dropping anchoring mechanism.

Figures 3a-3b are schematic diagrams of the structure of the anchoring member forming the connection point in the anchoring section.

4a-4m are schematic structural diagrams of various embodiments of the anti-dropping anchoring mechanism.

5a-5c are schematic diagrams of various structures of the connection between the anti-dropping anchoring mechanism and the cardiac tissue.

6a-6b are schematic structural diagrams of another embodiment of the anti-dropping anchoring mechanism.

7a-7e are schematic process diagrams of another embodiment.

The names of the parts referred to by the numbers in the drawings are as follows: 1-Stent, 11-Valve suture segment, 12-Atrial segment, 13-Anchoring area, 2-Anchoring mechanism for anti-shedding, 21-Anchoring piece, 22 -Anti-detachment piece, 3-Anchoring mechanism pushing device, 31-Delivery catheter, 32-Push rod, 4-Limiting piece, 5-Barb structure, 6-Micro-thorn, 7-Fixing device.

detailed description

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

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 away from the apex of the heart.

Specific embodiment one:

When used for the treatment of mitral valve disease, as shown in Fig. 1a and Fig. 1b, an anti-detachment anchoring mechanism applied to an implanted prosthesis includes a valve prosthesis 1, a pushing device 3, and a pushing device disposed on the pushing device The anti-detachment anchoring mechanism 2 in 3, the valve prosthesis 1 comprises a valve sewing segment 11 atrial segment 12 and an anchoring region 13, the atrial segment 12 is arranged at the distal end of the valve sewing segment 11, The anchoring region 13 is arranged on the atrium segment 12 , and the anchoring region 13 is provided with an anti-dropping anchoring mechanism 2 , and the anti-dropping anchoring mechanism 2 includes an anchoring member 21 and a falling-off preventing member 22 . , one end of the anchoring member 21 is fixedly connected with one end of the anti-dropping member 22 , as shown in FIGS. 2 a to 2 e , the push rod 32 located in the delivery catheter 31 pushes the anti-dropping anchoring mechanism 2 and makes the The other end of the anchoring member 21 passes through the anchoring area 13 and is connected to the cardiac tissue, and further pushes the anti-dropping anchoring mechanism 2; as shown in FIG. 3a, the other end of the anti-dropping member 22 passes through the The anchoring area 13 is folded back and finally forms two connection points with the anchoring area 13. The anti-dropping member 22 restricts the anchoring member 21 from leaving the anchoring area 13; the anchoring member 21 passes through the anchoring area. 13 is matched and connected with the heart tissue, so that the stent 1 is fixed in the heart, and the anti-detachment member 22 is finally connected to 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. , to avoid the situation in which the anchor 21 is loosened relative to the anchor area 13 and detached from the anchor area 13 .

The composition and connection mode of each component of the reversibly adjustable valve delivery system of the present invention will be described in detail below with reference to the accompanying drawings;

In this embodiment, as shown in FIG. 1b, 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-drop anchoring mechanism 2 Set in the delivery catheter 31, the anti-detachment anchoring mechanism 2 is set on the distal end side of the push rod 32. When the push rod 32 pushes the anti-detachment anchoring mechanism 2, the The other end of the anchoring member 21 passes through the anchoring area 13 and is connected with the heart tissue. When the push rod 32 is pushed further, the other end of the anti-dropping member 22 passes through the anchoring area 13 and finally connects with the anchor. The anchoring area 13 is matched and connected, and the disengagement prevention member 22 restricts the anchoring member 21 from being separated from the anchoring area 13 .

In another preferred embodiment, the pushing device 3 pushes the anti-detachment anchoring mechanism 2 and makes the other end of the anchoring piece 21 pass through the anchoring area 13 to be connected with the cardiac tissue, and further push the anti-detachment anchoring mechanism 2 . When the anchoring mechanism 2 is disengaged; as shown in FIG. 3b, the other end of the disengagement prevention member 22 passes through the anchoring area 13 and then folds back to form three connection points with the anchoring area 13. 22 restricts the anchoring member 21 from disengaging from the anchoring region 13 .

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

In this embodiment, the length of the anchoring member 21 is greater than the length of the anti-dropping member 22 ; the advantage of this design is that the main locking member fixes the stent 1 and the tissue, and the anti-dropping member 22 passes through the anchoring area 13 and Finally, it is connected with the anchoring area 13 so that the anti-dropping anchoring mechanism 2 is locked on the anchoring area 13, and the length of the auxiliary locking member is short, so it will not hook or compress the nerve bundle during the anchoring/locking process, Coronary venous sinus and other cardiac tissues can avoid damage or tearing of intracardiac tissues; at the same time, the shorter anti-dropping member 22 has a smaller torque and is less prone to deformation and pull-off, which can make the anti-dropping anchoring mechanism 2 and the The locking of the anchoring area 13 is more secure.

In this embodiment, the shape of the other end of the anchoring member 21 may be a spiral structure; similarly, the shape of the other end of the anti-dropping member 22 may also be a spiral structure, as shown in FIG. 4a , when When the shape of the other end of the anti-dropping member 22 is a helical structure, the anti-dropping member 22 and the anchoring area will form four connection points to further ensure that the anti-dropping member 22 will not be detached from the anchoring area 13. In this way, it is ensured that when the valve prosthesis 1 is impacted by blood flow, the anti-detachment member 22 can disperse/dissolve the impact force to these four stress points, thereby reducing the force of the anchoring member 21 and making the anti-detachment anchoring mechanism 2 is locked on the anchoring area 13 to prevent the anchoring piece 21 from loosening relative to the anchoring area 13 and detaching from the anchoring area 13 .

In another embodiment, the other end of the anti-dropping member 22 may be provided with a plurality of sharp parts, as shown in FIG. 4b , the other end of the anti-dropping member 22 passes through the anchoring area 13 and then is folded back and finally A plurality of connection points are formed with the anchoring region 13 .

In another embodiment, the anti-detachment anchoring mechanism 2 is further provided with a connecting section, as shown in FIG. 4c , the connecting section is arranged in an arc structure, and one end of the anchoring member 21 is connected to the connecting section. A segment is connected, and one end of the anti-falling member 22 is connected with the connection segment.

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

In another embodiment, as shown in FIG. 4f , when the anchoring member 21 is one or more arc-shaped anchoring needles, the anti-dropping member 22 can be one or more anchors of helical structure Fixed needle.

In another embodiment, as shown in FIG. 4g , when the anchoring member 21 can be one or more anchoring needles of helical structure, the anti-dropping member 22 can be one or more arc-shaped anchors Fixed needle.

In another embodiment, as shown in Figures 4h and 4i, when the anchoring member 21 can be one or more anchoring needles in helical structure, the anti-dropping member 22 can be one or more helical structures Anchoring needle of the like structure.

In another embodiment, the anti-dropping anchoring mechanism 2 further includes a limiting member 4. As shown in Figures 4j to 4m, one end of the anchoring member 21 and one end of the anti-dropping member 22 are respectively connected to the limiting member 4. Piece 4 is fixedly connected.

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 a known technology , such as rope sets, slip knots, etc.), after confirming that the anchoring effect of the anti-fall anchoring mechanism 2 is ideal, remove the above-mentioned movable connection, and then the pushing device 3 (including the delivery catheter 31 and the pushing The rod 32) is withdrawn from the human body, and the advantage of this design is that it can reduce the volume of the implant and reduce the risk of thrombosis.

In this embodiment, as shown in FIG. 5c , the other end of the anchoring member 21 is connected to the valve sewing segment 11 after passing through the anchoring region 13 and the heart tissue; more preferably, the other end of the anchoring member 21 is One end passes through the anchoring region 13, the heart tissue, and the valve sewing segment 11 and is between the prosthetic valve (not shown) and the valve sewing segment 11; the purpose of this design is that both ends of the anchoring member 21 are connected to the stent. 1 is connected, so that the two are connected as a whole, and the relative stent 1 is not easily loosened after the anchor 21 is implanted, so as to avoid the situation that the anchor 21 is pulled/detached from the anchor area 13 .

In this embodiment, as shown in FIG. 5a, after the other end of the anti-dropping member 22 passes through the anchoring region 13 and the heart tissue, it is finally connected to the anchoring region 13; the advantages of this design are: 22 needs to be finally connected to the anchoring area 13 after passing through the heart tissue, so that the anti-shedding member 22 is locked in the anchoring area 13 and connected with part of the heart tissue, further consolidating the anchoring effect of the anti-falling member 22; the same As shown in FIG. 5b, the other end of the anchoring member 21 can be passed through the anchoring region 13, the heart tissue, behind the valve sewing segment 11 and between the prosthetic valve (not shown) and the valve sewing segment 11. , and the other end of the anti-dropping member 22 is finally connected to the anchoring region 13 after passing through the anchoring region 13 and the cardiac tissue.

In this embodiment, as shown in Fig. 6a, the other end of the anchoring member 21 is provided with a barb structure 5 or the anchoring member 21 is evenly provided with micro-thorns 6; the anchoring member can be further increased The anchoring effect of 21 can more effectively avoid the pull-off/detachment of the anchoring member 21 from the anchoring area 13 .

In this embodiment, as shown in Fig. 6b, the end of the other end of the anti-dropping member 22 is provided with a barb structure 5 or the anti-dropping member 22 is evenly provided with micro-thorns 6; the advantages of this design are: The locking effect of the anti-releasing member 22 can be further increased, and the situation that the anchoring member 21 is pulled/detached from the anchoring area 13 is more effectively avoided.

Specific embodiment two:

When used for the treatment of tricuspid valve disease, as shown in Figs. 7a to 7e, an anti-detachment anchoring mechanism applied to an implanted prosthesis includes a stent 1 and a prosthetic valve (not shown), the stent 1 It includes a valve sewing segment 11, a fixing device 7 and an anchoring area 13, the anchoring area 13 is set on the fixing device 7, and the anchoring area 13 is provided with an anti-detachment anchoring mechanism 2, the One end of the fixation device 7 is connected to the proximal end portion of the valve sewing segment 11 , and the other end of the fixation device 7 is close to the patient's ventricular septum. The valve prosthesis is placed on the patient's ventricular septum and the axial movement of the valve prosthesis is restricted. The other end of the anchoring member 21 passes through the anchoring area 13 and is connected with the heart tissue, and the other end of the anti-dropping member 22 passes through the anchoring area 13 and then is folded back and finally forms two parts with the anchoring area 13 . The anchoring member 22 restricts the anchoring member 21 from being separated from the anchoring area 13; the anchoring member 21 is connected to the heart tissue through the anchoring area 13, so that the stent 1 is fixed in the heart, while preventing from falling off. After passing through the anchoring area 13, the component 22 is finally connected to the anchoring area 13, so that the anti-dropping anchoring mechanism 2 is locked on the anchoring area 13, so as to prevent the anchoring component 21 from loosening relative to the anchoring area 13 and removing the anchoring area from the anchoring area 13. 13 on the case of disengagement.

In this embodiment, the valve prosthesis further includes a pushing device 3, and the pushing device 3 includes a delivery catheter 31 and a push rod 32, and the push rod 32 and the anti-detachment anchoring mechanism 2 are provided in the delivery In the catheter 31 , when the push rod 32 pushes the anti-detachment anchoring mechanism 2 , the other end of the anchor 21 passes through the anchoring area 13 and is connected with the cardiac tissue, and when the push rod 32 is further pushed , the other end of the anti-dropping member 22 passes through the anchoring area 13 and is finally connected with the anchoring area 13 , and the anti-dropping member 22 restricts the anchoring member 21 from being separated from the anchoring area 13 .

In this embodiment, the length of the anchoring member 21 is greater than the length of the anti-dropping member 22 ; the advantage of this design is that the main locking member fixes the stent 1 and the tissue, and the anti-dropping member 22 passes through the anchoring area 13 and The final connection with the anchoring area 13 makes the anti-detachment anchoring mechanism 2 locked on the anchoring area 13, and the length of the auxiliary locking piece is short, so it will not affect other cardiac tissues during the anchoring/locking process, avoiding the need for The intracardiac tissue is damaged or torn; at the same time, the shorter anti-dropping member 22 has a smaller torque and is less likely to be deformed and pulled off, which can make the locking of the anti-dropping anchoring mechanism 2 and the anchoring region 13 more stable.

In this embodiment, both the anchoring member 21 and the anti-dropping member 22 have preset shapes; when the anchoring member 21 is one or more arc-shaped anchoring needles, the anti-dropping member 22 can be Anchor pins for one or more arcs.

In another embodiment, when the anchoring member 21 is one or more arc-shaped anchoring needles, the anti-dropping member 22 can be one or more anchoring needles of helical structure.

In another embodiment, when the anchoring member 21 can be one or more anchoring needles of helical structure, the anti-dropping member 22 can be one or more arc-shaped anchoring needles.

In another embodiment, when the anchoring member 21 can be one or more anchoring needles with a helical structure, the anti-dropping member 22 can be one or more anchoring needles with a helical structure.

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

In this embodiment, the end of the other end of the anchoring member 21 is provided with a barb structure 5 or the anchoring member 21 is evenly provided with micro-thorns 6; the anchoring effect of the anchoring member 21 can be further increased, It is more effective to avoid the pull-off/detachment of the anchoring member 21 from the anchoring region 13 .

In this embodiment, the end of the other end of the anti-dropping member 22 is provided with a barb structure 5 or the anti-dropping member 22 is evenly provided with micro-thorns 6; the advantage of this design is that the anti-dropping member can be further increased. The locking effect of 22 can more effectively avoid the pull-off/detachment of the anchoring member 21 from the anchoring area 13 .

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 in some other implanted prostheses that require anchoring mechanisms/anchoring devices; for example, in the field of occlusion For the occluder lacking in the heart or blood vessel, the anti-detachment anchoring mechanism can be anchored on the head of the occluder, so that the occluder can better fit the heart tissue and further improve the occlusion effect of the occluder.

The above contents are only preferred embodiments 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 embodiments and application scope. limits.

Claims

An anti-dropping anchoring mechanism applied to an implanted prosthesis, comprising: an implanted prosthesis, an anchoring area arranged on the implanted prosthesis, a pushing device, and an anti-dropping anchoring mechanism arranged in the pushing device, The anti-dropping anchoring mechanism includes an anchoring piece and an anti-dropping piece, one end of the anchoring piece is connected with one end of the anti-dropping piece, and the pushing device pushes the anti-dropping anchoring mechanism and makes the anchoring piece move. The other end passes through the anchoring area and is matched with the heart tissue. When the anti-dropping anchoring mechanism is further pushed, the other end of the anti-dropping piece passes through the anchoring area and then folds back and finally connects with the anchor. A certain area forms two or more connection points.
The anti-detachment anchoring mechanism applied to an implanted prosthesis according to claim 1, wherein the pushing device comprises a delivery catheter and a push rod, and the push rod and the anti-detachment anchoring mechanism are provided Within the delivery catheter, the anti-detachment anchoring mechanism is provided on the distal side of the push rod.
The anti-dropping anchoring mechanism applied to an implanted prosthesis according to claim 1, wherein the length of the anchoring member is greater than the length of the anti-dropping member.
The anti-dropping anchoring mechanism applied to an implanted prosthesis according to claim 1, wherein the anchoring member is one or more arc-shaped anchoring needles, and the anti-dropping member is one or more Arc Anchoring Needle.
The anti-detachment anchoring mechanism applied to an implanted prosthesis according to claim 1, wherein the anchoring region is covered with a membrane.
The anti-dropping anchoring mechanism applied to an implanted prosthesis according to claim 2, wherein one end of the push rod is detachably connected to the anti-dropping anchoring mechanism.
The anti-detachment anchoring mechanism applied to an implanted prosthesis according to claim 1, wherein the other end of the anchoring member is connected to the valve sewing segment after passing through the anchoring area and the heart tissue.
The anti-dropping anchoring mechanism applied to an implanted prosthesis according to claim 1, wherein the other end of the anti-dropping piece passes through the anchoring region and the heart tissue in sequence, and finally connects with the anchoring member. regional connection.
The anti-dropping anchoring mechanism applied to an implanted prosthesis according to claim 1, wherein the anti-dropping anchoring mechanism further comprises a limiting member, and one end of the anchoring member and one end of the anti-dropping member are respectively fixedly connected with the limiter.
The anti-detachment anchoring mechanism applied to an implanted prosthesis according to claim 1, wherein the end of the other end of the anchoring member is provided with a barb structure, or the anchoring member is evenly arranged on the anchoring member There are micro-thorns, or the end of the other end of the anti-dropping member is provided with a barb structure, or the anti-dropping member is evenly provided with micro-thorns.