CN114452039A - Mitral valve forming ring - Google Patents

Abstract

The invention discloses a mitral valve annuloplasty ring, comprising: a contraction wire having a shape memory function and being annular in a free state; the forming ring body comprises a plurality of sections of contraction joints which are sequentially sleeved on the periphery of the contraction line and are of soft structures, the plurality of sections of contraction joints can be connected end to form an annular structure, and a contraction interval is arranged between every two adjacent sections of contraction joints. The forming ring body drives the plurality of contraction joints to be connected end to form an annular structure under the action of the contraction wire, the contraction joints are of soft structures and can be relatively close to the physiological activity of the mitral valve annulus, and the coordinated motion with the cardiac cycle can be realized; further, the ring body can be formed in a linear shape when it is loaded into the loading chamber of the transport system, and has an advantage of a smaller transport diameter than a ring body of a folding type structure.

Description

A mitral annuloplasty ring

technical field

The invention relates to the technical field of medical devices, in particular to a mitral valve angioplasty ring.

Background technique

Mitral valvuloplasty treats mitral regurgitation heart valve disease by implanting an artificial mitral valvuloplasty ring. Prosthetic mitral valvuloplasty rings are used as part of mitral valvuloplasty to aid in the correction of heart valve defects such as mitral regurgitation. The mitral valve includes the mitral valve annulus, valve leaflets, papillary muscles, and chordae tendineae. Mitral regurgitation is the backflow of blood from the left ventricle through the mitral valve to the left atrium when the left ventricle contracts. Dilation of the mitral valve annulus impedes the ability of the valve, resulting in a distortion of the normal shape of the valve orifice.

For the surgical treatment of mitral regurgitation, mitral valvuloplasty has significant advantages over mitral valve replacement in terms of survival, valve complications, and valve durability. There are two main types of mitral annuloplasty rings: rigid rings and flexible rings. The material of the rigid ring is hard, not easy to bend, and cannot achieve coordinated movement with the cardiac cycle. The flexible annulus is similar to the normal mitral valve annulus in physiological activity, and has little effect on left ventricular function, but has poor supporting and shaping effects.

Before performing mitral valvuloplasty, the forming ring needs to be adjusted to be linearly loaded into the forming ring loading cavity of the delivery system. The rigid ring is generally loaded into the forming ring loading cavity in a folded structure, but the folded structure has The delivery diameter of the rigid ring is large, and the size of the loading cavity of the forming ring is relatively high; while the flexible ring has a small delivery diameter, but the supporting and forming effects are poor, and the recurrence of mitral regurgitation is prone to occur after surgery.

Therefore, it is necessary to design a mitral annuloplasty ring that can meet the requirements of support strength and deliver a smaller diameter.

SUMMARY OF THE INVENTION

Therefore, the technical problem to be solved by the present invention is to overcome the defect that the mitral annuloplasty ring in the prior art is difficult to have both high support strength and small delivery diameter, so as to provide a mitral annuloplasty ring.

For solving the above-mentioned technical problems, the technical scheme of the present invention is as follows:

A mitral annuloplasty ring, comprising:

Shrinking wire, with shape memory function, is annular in free state;

The forming ring body includes a plurality of shrinking sections which are sequentially sleeved on the outer periphery of the shrinking line and have a soft structure. Contraction interval.

Further, the annular structure formed by the end-to-end connection of the plurality of shrinking segments is an intermittent annular structure, and the surfaces of the two adjacent shrinking segments at the shrinking interval are cross-sections.

Further, the annular structure formed by the end-to-end connection of a plurality of the contraction joints is a complete annular structure, and two adjacent contraction joints are provided with link segments at the contraction interval.

Further, the shape of the annular structure formed by connecting the multiple segments end to end is matched with the physiological structure of the human mitral valve.

Further, the shrinkage section is made of silicone material.

Further, the shrinking wire is made of memory alloy material.

Further, the shrinking joint includes a head-end shrinking joint, a plurality of middle-section shrinking joints and a tail-end shrinking joint which are arranged in sequence; The body is in a ring structure.

Further, the buckle structure includes a clip provided on the first end shrinking section and a clip provided on the tail end contraction section and engaged with the clip.

Further, the end face of the tail end shrinking section facing the tail end shrinking section is a wire take-up end, and the buckle is connected to the wire take-up end.

Further, the end face of the head end constriction joint toward the tail end constriction joint is the outgoing end, a part of the clip is arranged in the inner cavity of the outgoing end, and the other part extends outward from the outgoing end. .

Further, the outer surface of the clamping strip is provided with clamping strip barbs, the inner surface of the clamping buckle is provided with clamping claws, and the clamping strip barbs are engaged with the clamping claws.

Further, the clips are arc-shaped or straight-shaped.

Further, the end of the clip located in the outlet end is the head end of the clip, the other end of the clip extending out of the outlet end is the tail end of the clip, and the tail end of the clip into the buckle.

Further, one end of the shrinking wire is fixedly connected to the head end of the clip, and the other end of the shrinking wire is fixedly connected to the buckle.

Further, each section of the shrinking section is provided with a guide groove, the shrinkage line includes a guide exposed section corresponding to the opening of the guide groove, and the guide exposed section is surrounded with a shaped guide wire, and the Both ends of the shaping guide wire extend from the guide slot and are connected to the delivery system.

Further, the guide groove is arranged on a side of the shrinking joint close to the center of the annular structure.

Further, a traction hole is opened on the proximal end side of the tail end constriction joint, a traction wire is passed through the tail end of the clip, and the two ends of the traction wire are connected to the traction hole after passing through the traction hole. Conveyor system.

Further, the surface of the shrinking section of each section is covered with a coating substrate.

Further, the cladding base material includes a nickel-titanium alloy mesh, and the nickel-titanium alloy mesh includes a cladding segment that is clad on the surface of the shrinkage joint and that is connected to the cladding segment and faces away from the annular structure. An extension that extends outward in the direction of the center.

Further, the coating base material also includes a ring-shaped PET mesh cloth, the PET mesh cloth includes an upper layer PET mesh cloth and a lower layer PET mesh cloth, and the upper layer PET mesh cloth and the lower layer PET mesh cloth are wrapped on the outer surface of the extension of the nitinol mesh.

Further, the coating base material further comprises a ring-shaped PET mesh cloth, and the PET mesh cloth is coated on the outer surfaces of the plurality of segments of the shrinking joints and the plurality of the nickel-titanium alloy meshes.

Further, the coating base material further includes a fan-shaped multi-segment PET mesh cloth, and each segment of the PET mesh cloth coats a corresponding section of the shrinking section and the outer surface of the nickel-titanium alloy mesh above.

Further, the nickel-titanium alloy mesh is fan-shaped.

Further, the forming ring body is connected with the autologous valve leaflets of the human body through rivets passing through the covering base material.

The technical scheme of the present invention has the following advantages:

1. The mitral annuloplasty ring provided by the present invention, the forming ring body includes a constriction line with a memory function and an annular shape in a free state and a plurality of contractile segments that are soft structures. When the forming ring body reaches the atrial septum with the delivery system. When the mitral valve is above the mitral valve, operate the delivery system to release the forming ring body. Under the force of the contraction line returning to its free form, the forming ring body drives multiple contraction segments to connect end to end to form an annular structure. The physiological activity of the cusp valve annulus is relatively close, and the coordinated movement with the cardiac cycle can be realized. Because the contraction line is a rigid structure and has a memory function, the contraction line can provide the support force for the ring body to maintain the annular state, so that the ring body can be It can meet the required supporting force requirements; moreover, when the forming ring body is loaded into the loading cavity of the conveying system, it can be in a straight shape. Successful implantation of the cusp annuloplasty ring.

2. In the mitral valve angioplasty ring provided by the present invention, the annular structure formed by the end-to-end connection of the multiple constricting segments is an interrupted annular structure. When the operation delivery system releases the angioplasty ring body, the constricting segments hinder the retraction line from recovering its free form. The force is small, which is favorable for the end-to-end connection of the contractile segments to form an annular structure of a desired shape, so as to achieve matching with the physiological structure of the human mitral valve.

3. The mitral annuloplasty ring provided by the present invention adopts the contractile joint made of silica gel material, which has good elasticity and good biocompatibility, and can conform to the physiological activity of the mitral valve annulus of the human body.

4. In the mitral valve angioplasty ring provided by the present invention, the constriction section at the head end and the constriction section at the tail end are connected by a buckle structure to form the ring body into a ring structure, and the buckle structure can increase the retention of the ring body after it is formed into a ring. The stability of the formed ring shape is beneficial to improve the support strength of the formed ring body after the ring is formed.

5. In the mitral annuloplasty ring provided by the present invention, the buckle structure adopts a structure in which the clips on the constricting section at the head end and the clipping strips on the constricting section at the tail end are engaged. Under the action of the shrink line, the clip and the clip can be automatically buckled, reducing external force operation, which is conducive to the smooth operation of the operation.

6. In the mitral valve angioplasty ring provided by the present invention, the clip is arc-shaped, which is adapted to the curvature of the forming ring body, which is beneficial for the clip to be inserted into the buckle to automatically realize the engagement.

7. The mitral valve angioplasty ring provided by the present invention has a guide groove on each constriction section, and the shaping guide wire is wound around the guide exposed section corresponding to the guide groove of the shrink line, and the two ends of the shaping guide wire are After extending from the guide groove, it is connected to the conveying system; by pulling the shaping guide wire through the conveying system, the shape of the forming ring body after being formed into a ring can be fine-tuned, so that the forming ring body can be shaped, which is conducive to the formation of the desired shape after the forming ring body is released. ring structure.

8. The mitral valve angioplasty ring provided by the present invention is provided with a traction hole on the proximal side of the caudal constriction joint, a traction wire is pierced at the tail end of the clip, and the two ends of the traction wire are pierced through the traction hole. After exiting, it is connected to the conveying system; in this way, the movement of the traction line can be operated through the conveying system, and then the clip can be driven to move into the retracted joint at the tail end, and the length of the clip extending into the clip can be adjusted, thereby increasing the clip and clip. bar connection reliability.

9. The mitral valve angioplasty ring provided by the present invention is covered with a covering base material on the surface of the constriction joint, and the forming ring body is connected with the autologous valve leaflets of the human body through rivets passing through the covering base material, so there is no need to shrink the ring. Holes are punched on the joints, and the covering substrate can be used as the base surface for rivet positioning, which is convenient for rivet driving, avoiding the situation of inaccurate rivet positioning and repeated damage to the biological tissue when the rivet is pulled out.

Description of drawings

In order to illustrate the specific embodiments of the present invention or the technical solutions in the prior art more clearly, the following briefly introduces the accompanying drawings that need to be used in the description of the specific embodiments or the prior art. Obviously, the accompanying drawings in the following description The drawings are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can also be obtained based on these drawings without creative efforts.

1 is a three-dimensional structural diagram of a mitral annuloplasty ring according to an embodiment of the present invention;

2 is a top view of a mitral annuloplasty ring according to an embodiment of the present invention;

3 is a schematic diagram of the wire outlet end and the wire take-up end on the mitral annuloplasty ring in an embodiment of the present invention;

4 is a front view of a mitral annuloplasty ring according to an embodiment of the present invention;

FIG. 5 is a cross-sectional view of the BB plane in FIG. 4;

Fig. 6 is the sectional view of AA plane in Fig. 4;

7 is a schematic diagram of the connection relationship between the coating base material and the shrinkage joint in the first embodiment of the embodiment of the present invention;

8 is a schematic diagram of the connection relationship between the coating base material and the shrinkage joint in the second embodiment of the embodiment of the present invention;

9 is a schematic diagram of the connection relationship between the coating base material and the shrinkage joint in the third embodiment of the embodiment of the present invention;

10 is a schematic diagram of the connection relationship between the coating base material and the shrinkage joint in the fourth embodiment of the embodiment of the present invention;

FIG. 11 is a positional relationship diagram of a rivet and a forming ring loading cavity on a conveying system according to an embodiment of the present invention;

Figure 12 is a schematic diagram of the physiological anatomy of the human mitral valve;

13 is a schematic diagram of an annular structure formed by connecting end to end multi-section shrinkage sections with a “D” shape in the fifth implementation of the embodiment of the present invention;

FIG. 14 is a schematic diagram of a complete annular structure formed by connecting end-to-end multi-segment shrinkage segments provided with link segments in the sixth implementation manner of the embodiment of the present invention.

Description of reference numerals: 1. Shrinkage section; 101, Shrinkage interval; 102, Guide groove; 110, Head end shrinkage section; 111, Outgoing wire end; ;132, traction hole; 140, clip; 141, clip barb; 142, clip head; 143, clip tail; 150, buckle; 151, jaw; 160, link segment; 2, shrink Wire; 201, guide exposed section; 3, shape guide wire; 4, traction wire; 5, coated substrate; 501, nickel-titanium alloy mesh; 502, PET mesh; 6, rivet; 7, forming ring loading cavity; 8. Autologous valve leaflets.

Detailed ways

The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are a part of the embodiments of the present invention, but not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. The indicated azimuth or positional relationship is based on the azimuth or positional relationship shown in the attached drawings, "proximal end" refers to the end farther away from the operator, and "distal end" refers to the end farther away from the operator. The invention and simplified description do not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operate in a particular orientation, and therefore should not be construed as limiting the invention. Furthermore, the terms "first", "second", and "third" are used for descriptive purposes only and should not be construed to indicate or imply relative importance.

In the description of the present invention, it should be noted that the terms "installed", "connected" and "connected" should be understood in a broad sense, unless otherwise expressly specified and limited, for example, it may be a fixed connection or a detachable connection Connection, or integral connection; can be mechanical connection, can also be electrical connection; can be directly connected, can also be indirectly connected through an intermediate medium, can be internal communication between two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood in specific situations.

In addition, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

As shown in Figures 1-11, a mitral valve angioplasty ring includes a shrinking wire 2 and a forming ring body; wherein, the shrinking wire 2 has a shape memory function and is annular in a free state; the forming ring body includes sequentially sleeved On the outer periphery of the shrink line 2, the multi-segmented contraction joints 1 having a soft structure can be connected end to end to form an annular structure, and a contraction interval 101 exists between two adjacent contraction joints 1.

In this mitral angioplasty ring, when the angioplasty ring body passes through the atrial septum with the delivery system and reaches the top of the mitral valve, the delivery system is operated to release the angioplasty ring body, and under the force of the retraction wire 2 to restore the free form, the angioplasty ring body drives many The systolic segments 1 are connected end to end to form an annular structure. Since the systolic segment 1 is a soft structure, it is closer to the normal mitral valve annulus physiological activity, and can achieve coordinated movement with the cardiac cycle. Memory function, the shrinking line 2 can provide the supporting force for the forming ring body to maintain the annular state, so that the forming ring body can meet the required supporting force requirements; The straight shape, compared with the existing foldable structure of the angioplasty ring body, has a smaller delivery diameter, which is beneficial to the smooth implantation of the mitral annuloplasty ring.

In a specific implementation of this embodiment, the shrinking joint 1 includes a head-end shrinking joint 110 , a four-stage middle-section shrinking joint 120 and a tail-end shrinking joint 130 arranged in sequence, and the first-end shrinking joint 110 and the tail-end shrinking joint 130 pass through The engagement of the snap structures makes the forming ring body into an annular structure. In an alternative embodiment, the number of the mid-section constriction joints 120 may also be 2, 3, 5 or more. The manner in which the first-end constriction joint 110 and the tail-end constriction joint 130 are connected by the buckle structure to make the forming ring body form a ring structure can increase the stability of maintaining the ring shape after the forming ring body is formed into a ring, which is beneficial to improve the forming ring body Support strength after ring formation.

Specifically, the shrinkage section 1 is made of silica gel material, the shrinkage wire 2 is made of nickel-titanium memory alloy material, and the shrinkage wire 2 is passed between the multiple-section shrinkage sections 1 . The contraction joint 1 made of silicone material has good biocompatibility and good elasticity, and can conform to the physiological activities of the human mitral valve annulus; and the silicone contraction joint 1 is a mass-produced material that can be produced by injection molding, and also has The advantages of low production cost and high production efficiency. The nickel-titanium memory alloy has a strong function of restoring its own state, which is conducive to the formation of a ring-shaped ring body.

In a specific implementation of this embodiment, the annular structure formed by the end-to-end connection of the multiple-section shrinking joints 1 is an intermittent annular structure, and the surfaces of the two adjacent shrinking joints 1 at the shrinking interval 101 are cross-sections; The shape of the annular structure formed by the end-to-end connection of the constricted segments 1 is a "D" shape, which matches the physiological structure of the human mitral valve. With the forming ring body of this structure, when the conveying system is operated to release the forming ring body, the impeding force of the shrinking section 1 on the recovery of the shrinking wire 2 to its free form is small, which is beneficial to the end-to-end connection of the shrinking section 1 to form a ring structure of the desired shape , to match the physiological structure of the human mitral valve. In an alternative embodiment, the annular structure formed by the end-to-end concatenation of the multiple constricted joints 1 is a complete annular structure, and two adjacent constricted joints 1 are provided with link segments 160 at the constricted interval 101 .

In a specific implementation of this embodiment, the buckle structure includes a clip 140 disposed in the head end contraction section 110 and a clip 150 disposed on the tail end contraction section 130 and matched with the clip strip 140 . The outer surface of the clip 140 is integrally formed with a plurality of clip barbs 141 arranged along the length direction, the clip 150 is a tubular structure, and the inner surface of the clip 150 is formed with a clip 151, the clip barb 141 and the clip 151 fit together. The buckle structure adopts the structure in which the clips 140 on the first end shrinking section 110 and the clips 140 on the tail end shrinking section 130 are fastened together. The strip 140 and the buckle 150 can be automatically buckled to reduce external force operation, which is beneficial to the smooth operation of the operation. In alternative embodiments, the positions of the clips 150 and the clips 140 may be interchanged.

In this embodiment, the end face of the tail end constricting joint 130 toward the tail end constricting joint 130 is specifically the wire take-up end 131 , and the end face of the head end constricting joint 110 facing the tail end constricting joint 130 is the wire outlet end 111 . The clip 150 is connected to the wire take-up end 131 ; a part of the clip 140 extends into the inner cavity of the wire outlet end 111 , and the other part extends outward from the wire outlet end 111 .

In a specific implementation of this embodiment, the clip 140 is in an arc shape, which can be adapted to the curvature of the forming ring body, which is beneficial for the clip 140 to be inserted into the interior of the clip 150 to automatically engage, thereby realizing the forming ring self-locking. The end of the clip 140 located in the outlet end 111 is the head end of the clip 140 , and the other end of the clip 140 extending out of the outlet end 111 is the tail end of the clip 140 . One end of the shrinking wire 2 is fixedly connected with the head end of the clip 140 , and the other end of the shrinking wire 2 passes out of the head end shrinking joint 110 , passes through the middle section shrinking section 120 and the tail end shrinking section 130 in turn and is fixedly connected to the buckle 150 . In an alternative embodiment, the clip 140 can also be in a straight shape, and the other end of the shrinking wire 2 can also be fixedly connected with the tail end shrinking section 130 .

In this embodiment, a guide groove 102 is provided on the side of each shrinking section 1 close to the center of the annular structure, and the part of the shrinking line 2 corresponding to the opening of the guide groove 102 is the guide-exposed section 201 , and the guide-exposed section 201 surrounds the A shaping guide wire 3 is provided, and the two ends of the shaping guide wire 3 protrude from the guide groove 102 and are connected to the conveying system. By pulling the setting guide wire 3 by the conveying system, the shape of the forming ring body after being formed into a ring can be fine-tuned, so that the forming ring body can be shaped, which is conducive to forming a ring structure with a desired shape after the forming ring body is released, and connecting the forming ring with the conveying system. Stable connection.

In this embodiment, a pulling hole 132 is formed on the proximal side of the tail end shrinking joint 130 , and a pulling wire 4 is passed through the tail end of the clip 140 . The pulling hole 132 is pierced and connected to the delivery system. Among them, the proximal end and the distal end respectively refer to the end near the operator and the far end. In this way, the traction wire 4 can be operated by the conveying system to move, and then the clip 140 can be driven to move toward the rear end contraction joint 130, and the length of the clip 140 extending into the clip 150 can be adjusted, thereby increasing the clip 150 and clip 150. 140 connection reliability and achieve forming shrinkage.

In this embodiment, the surface of each shrinking section 1 is covered with a matching covering base material 5 . The forming ring body is connected to the body's own valve leaflets through the rivets 6 passing through the covering base material 5; in this way, there is no need to drill holes on the shrinkage joint 1, and the covering base material 5 can be used as the base surface for the rivets 6 to be positioned. The driving of the rivet 6 is convenient, and the problems of inaccurate positioning and easy falling off of the rivet 6 are avoided.

In the first implementation of this embodiment, as shown in FIG. 7 , the coating base material 5 includes a nickel-titanium alloy mesh 501 , the nickel-titanium alloy mesh 501 is fan-shaped, and the nickel-titanium alloy mesh 501 includes a coating on the shrinkage joint 1 . A cladding section of the surface of the cladding section and an extension section connected to the cladding section and extending outward in a direction away from the center of the annular structure. Under the action of the nickel-titanium alloy mesh 501, the nickel-titanium alloy mesh 501 can maintain a fan-shaped surface to fit the upper surface of the autologous valve leaflet of the human body. .

In the second embodiment of this embodiment, as shown in FIG. 8 , the difference from the first embodiment is that the covering substrate 5 further includes a ring-shaped PET mesh cloth 502 , and the PET mesh cloth 502 includes The upper layer PET mesh cloth 502 and the lower layer PET mesh cloth 502, the upper layer PET mesh cloth 502 and the lower layer PET mesh cloth 502 are wrapped on the outer surface of the extension section of the nickel-titanium alloy mesh 501 by sewing.

In the third embodiment of this embodiment, as shown in FIG. 9 , the difference from the second embodiment is that the PET mesh cloth 502 is wrapped around the multi-section shrinkage section 1 and the plurality of nickel-titanium alloy meshes 501 the outer surface.

In the fourth embodiment of this embodiment, as shown in FIG. 10 , the difference from the third embodiment is that the coating substrate 5 has multiple sections, and each section of the coating substrate 5 is fan-shaped. There is a gap between two adjacent sections of cladding base material 5 , and the length of each section of cladding base material 5 covering the corresponding shrinking joint 1 is the same as the length of the shrinking joint 1 .

In this embodiment, the structure of the delivery system is shown in FIG. 11 , a forming ring loading cavity 7 is arranged in the middle of the delivery system. Before the operation, the forming ring body is linearly loaded into the forming ring loading cavity 7 of the delivery system. middle. The delivery system is also connected to a plurality of rivets 6 on the outer periphery of the forming ring loading chamber 7 on the end face of the outlet of the forming ring loading chamber 7 , and the rivets 6 are used to fix the forming ring body on the outer circumference of the native valve leaflet. Specifically, the rivets 6 pass through the upper layer PET mesh cloth 502, the Nitinol alloy mesh 501, the lower layer PET mesh cloth 502 and the autologous valve leaflets in sequence from top to bottom. The upper end of the rivet 6 is hung on the PET mesh 502 and the Nitinol mesh 501 through a barb-shaped structure or other structures, and the lower end of the rivet 6 is abutted against the lower surface of the native valve leaflet through the barb-shaped structure. After the forming ring body is initially formed by the shrinking wire 2, the corresponding rivets 6 are then driven to form a ring structure with the desired shape.

Specifically, as shown in FIGS. 1-10 , the shape of the annular structure formed by the multiple segments of the constricted segments 1 of the mitral annuloplasty ring being connected end to end is an annular shape that matches the physiological structure of the human mitral valve;

In this embodiment, as shown in Fig. 12 is a schematic diagram of the physiological anatomy of the human mitral valve: the physiological structure of the human mitral valve is close to the "D" shape, and the edge of the A region (including A1, A2, A3) is close to the "D" shape. The straight side of the D" shape, the edge of the P area (including P1, P2, P3) is the arc edge close to the "D" shape;

In the fifth implementation of this embodiment, as shown in FIG. 13 , in order to be closer to the physiological structure of the mitral valve of the human body, in a preferred embodiment, multiple segments of the contraction segments 1 are formed end to end. The shape of the annular structure is in the shape of a "D" that matches the physiological structure of the human mitral valve. Specifically, at least one of the multiple constricted segments 1 is a linear constricted segment; the linear constricted segment corresponds to It is matched with the edge of the area A of the physiological structure of the human mitral valve, and the other contraction joints 1 are attached to the edge of the P area of the physiological structure of the human mitral valve; further, the two ends of the linear contraction joint are provided with There are bending heads, and the bending heads are all bent toward the adjacent contraction joints 1;

In the sixth implementation of this embodiment, as shown in FIG. 14 , the annular structure formed by connecting multiple segments of the shrinking segments 1 end to end is a complete annular structure, and two adjacent segments of the shrinking segments 1 are in the A link segment 160 is provided at the contraction interval. Specifically, the link segment 160 keeps the adjacent contraction segments 1 at a certain distance. The link segment 160 is compressed only. During the compression process, the link segment is bent outward to form an "Ω" shape, and the formed ring body forms a ring structure similar to the above-mentioned embodiment.

The working principle of this mitral annuloplasty ring is as follows: before performing the operation, the ring body is adjusted to be linearly loaded into the ring loading cavity 7 of the delivery system, at this time the ring is in the direction of the proximal end to the distal end. , followed by the buckle 150 , the tail end shrinking joint 130 , the four-section middle-section shrinking joint 120 , and the head end shrinking joint 110 . When the delivery system reaches the top of the mitral valve through the interatrial septum, the delivery system is operated to release the forming ring body, and the forming ring body is initially formed into a ring under the action of the shrinking wire 2 made of nickel-titanium alloy. Next, shape the forming ring body. The surface of the contraction joint 1 is covered with a nickel-titanium alloy mesh 501 and a PET mesh cloth 502, and the fan-shaped surface is maintained under the action of the nickel-titanium alloy mesh 501 to fit the upper surface of the autologous valve leaflet of the human body; a number of rivets 6 are punctured by operating the delivery system , through the upper layer of PET mesh cloth 502, the nickel-titanium alloy mesh 501, the lower layer of PET mesh cloth 502, the human body's autologous valve leaflets, and finally through the barbs or barbs of the delivery system to fix the forming ring and the autologous valve leaflets.

After fixing the forming ring body and the native valve leaflet, the clip 140 is inserted toward the buckle 150 by pulling the pulling wire 4 until the forming ring shrinks to the required size, and the claws 151 of the clip 150 and the clip barbs 141 are mutually locked. , to complete the contraction. When disconnecting the conveying system, one end of each pulling wire 4 is cut off, and the other end is pulled to recover.

To sum up, in the mitral annuloplasty ring provided by the embodiment of the present invention, the annuloplasty ring body includes a constriction wire 2 with a memory function and an annular shape in a free state and a plurality of constriction segments 1 with a soft structure. When the delivery system passes through the interatrial septum and reaches the top of the mitral valve, operate the delivery system to release the forming ring body, and the forming ring body drives multiple contractile segments 1 end to end to form a ring structure under the force of the contraction wire 2 to restore its free form. The systolic segment 1 is a soft structure, which is close to the physiological activity of the normal mitral valve annulus, and can realize coordinated movement with the cardiac cycle. In addition, since the systolic line 2 is a rigid structure and has a memory function, the systolic line 2 can provide the forming ring body. The supporting force in the annular state is maintained, so that the forming ring body can meet the required supporting force requirements; moreover, when the forming ring body is loaded into the loading cavity of the conveying system, it can be in a straight shape, which is different from the forming ring of the existing folding structure. Compared with the body, the delivery diameter is smaller, which is beneficial to the smooth implantation of the mitral annuloplasty ring.

Obviously, the above-mentioned embodiments are only examples for clear description, and are not intended to limit the implementation manner. For those of ordinary skill in the art, changes or modifications in other different forms can also be made on the basis of the above description. There is no need and cannot be exhaustive of all implementations here. And the obvious changes or changes derived from this are still within the protection scope of the present invention.

Claims (24)

1. a mitral annuloplasty ring, is characterized in that, comprises; The shrinking line (2) has a shape memory function and is annular in a free state; The forming ring body comprises multiple shrinking joints (1) which are sequentially sleeved on the outer periphery of the shrinking line (2) and have a soft structure. A contraction interval (101) is provided between the two contraction segments (1). 2. The mitral annuloplasty ring according to claim 1, characterized in that, the annular structure formed by the end-to-end connection of multiple said constricting segments (1) is an interrupted annular structure, and the two adjacent constricting segments (1) are discontinuous annular structures. 1) The surface at the shrinkage interval (101) is a section. 3. The mitral annuloplasty ring according to claim 1, characterized in that, the annular structure formed by connecting multiple segments (1) end to end is a complete annular structure, and two adjacent segments (1) of the contraction segments ( 1) A link segment (160) is provided at the contraction interval (101). 4 . The mitral annuloplasty ring according to claim 1 , characterized in that the shape of the annular structure formed by connecting multiple segments ( 1 ) end to end matches the physiological structure of the human mitral valve. 5 . 5 . The mitral annuloplasty ring according to claim 1 , wherein the constriction section ( 1 ) is made of silicone material. 6 . 6 . The mitral annuloplasty ring according to claim 1 , wherein the shrinking wire ( 2 ) is made of memory alloy material. 7 . 7 . The mitral annuloplasty ring according to claim 1 , wherein the constriction segment ( 1 ) comprises a head end constriction segment ( 110 ), a plurality of middle segment constriction segments ( 120 ) and a tail end constriction segment arranged in sequence. 8 . (130); the head end constriction section (110) and the tail end constriction section (130) are connected by a snap structure, so that the forming ring body is formed into a ring structure. 8 . The mitral annuloplasty ring according to claim 7 , wherein the buckle structure comprises a clip ( 140 ) arranged on the contraction section ( 110 ) at the head end and a clip ( 140 ) arranged at the tail end. 9 . A buckle (150) on the contraction joint (130) and engaged with the clip (140). 9 . The mitral annuloplasty ring according to claim 8 , wherein the end face of the caudal constriction section ( 130 ) toward the caudal constriction section ( 130 ) is the take-up end ( 131 ), and the The buckle (150) is connected to the wire take-up end (131). 10. The mitral annuloplasty ring according to claim 8, wherein the end face of the head-end constriction section (110) toward the tail-end constriction section (130) is an outlet end (111), and the clip A part of the strip (140) is arranged in the inner cavity of the wire outlet end (111), and the other part extends outward from the wire outlet end (111). 11 . The mitral annuloplasty ring according to claim 8 , characterized in that, the outer surface of the clip ( 140 ) is provided with clip barbs ( 141 ), and the inner surface of the clip ( 150 ) is provided on the inner surface of the clip ( 150 ). A clamping claw (151) is provided, and the clamping bar barb (141) is engaged with the clamping claw (151). 12. The mitral annuloplasty ring according to claim 8, wherein the clip (140) is arc-shaped or linear. 13. The mitral annuloplasty ring according to claim 12, wherein the end of the clip (140) located in the outlet end (111) is the head end of the clip (140). The other end of the strip (140) extending out of the wire outlet end (111) is the tail end of the clip (140), and the tail end of the clip (140) extends into the buckle (150). 14. The mitral annuloplasty ring according to claim 13, wherein one end of the contraction wire (2) is fixedly connected to the head end of the clip (140), and the other end of the contraction wire (2) is fixedly connected. One end is fixedly connected with the buckle (150). 15. The mitral annuloplasty ring according to any one of claims 1-14, wherein a guide groove (102) is provided on each of the contraction segments (1), and the contraction lines ( 2) It includes a guide exposed segment (201) corresponding to the opening of the guide groove (102), the guide exposed segment (201) is surrounded with a shaping guide wire (3), and the shaping guide wire (3) is Both ends protrude from the guide slot (102) and are connected to the delivery system. 16. The mitral annuloplasty ring according to claim 15, characterized in that, the guide groove (102) is provided on the side of the constriction (1) close to the center of the annular structure. 17. The mitral annuloplasty ring according to claim 14, wherein a traction hole (132) is opened on the proximal end side of the caudal constrictor (130), and the caudal end of the clip (140) is provided with a traction hole (132). A pulling wire (4) is passed through, and the two ends of the pulling wire (4) are connected to the conveying system after passing through the pulling hole (132). 18. The mitral annuloplasty ring according to any one of claims 1-14, characterized in that, the surface of each segment of the contraction segment (1) is coated with a coating substrate (5). 19. The mitral annuloplasty ring according to claim 18, characterized in that, the coating base material (5) comprises a nickel-titanium alloy mesh (501), and the nickel-titanium alloy mesh (501) comprises a A cladding section of the surface of the constriction (1) and an extension section connected to the cladding section and extending outward in a direction away from the center of the annular structure. 20. The mitral annuloplasty ring according to claim 18, characterized in that, the coating substrate (5) further comprises a ring-shaped PET mesh (502), the PET mesh (502) comprising an upper layer A PET mesh cloth (502) and a lower layer of PET mesh cloth (502), the upper layer of PET mesh cloth (502) and the lower layer of PET mesh cloth (502) are covered on the extending section of the nickel-titanium alloy mesh (501) The outer surface. 21. The mitral annuloplasty ring according to claim 18, characterized in that, the covering base material (5) further comprises a ring-shaped PET mesh cloth (502), and the PET mesh cloth (502) wraps On the outer surfaces of the plurality of sections of the shrinking section (1) and the plurality of the nickel-titanium alloy meshes (501). 22. The mitral annuloplasty ring according to claim 18, characterized in that, the coating base material (5) further comprises a fan-shaped multi-section PET mesh cloth (502), and each section of the PET mesh cloth (502) ) covers the outer surface of the corresponding shrinkage section (1) and the nickel-titanium alloy mesh (501) above. 23. The mitral annuloplasty ring according to any one of claims 19-22, wherein the nitinol mesh (501) is fan-shaped. 24. The mitral annuloplasty ring according to claim 18, characterized in that, the annulus body is connected to the native valve leaflets of the human body by rivets (6) passing through the covering base material (5).

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