Mitral valve forming ringTechnical Field
The invention relates to the technical field of medical appliances, in particular to a mitral valve shaping ring.
Background
Mitral valve angioplasty treats mitral regurgitation heart valve disease by implanting a prosthetic mitral annuloplasty ring. A prosthetic mitral valve annuloplasty ring is used as part of a mitral valve arthroplasty to assist in the correction of heart valve defects, such as mitral insufficiency. The mitral valve includes the mitral annulus, leaflets, papillary muscles and chordae tendineae. Mitral regurgitation is the regurgitation of blood from the left ventricle through the mitral valve to the left atrium when the left ventricle contracts. Dilation of the mitral annulus can prevent the ability of the valve, resulting in distortion of the normal shape of the valve orifice.
For surgical treatment of mitral regurgitation, mitral valve angioplasty 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 in common use today, rigid rings and flexible rings. The rigid ring is hard in material, not easy to bend and can not realize coordinated movement with the cardiac cycle. The flexible ring is closer to the normal mitral valve annulus physiological activity, has smaller influence on the left ventricle function, has poorer supporting and shaping effects, is easy to cause mitral regurgitation recurrence after operation, and has higher operation rate.
Before performing a mitral valve annuloplasty, the annuloplasty ring needs to be adjusted to be linearly loaded into an annuloplasty ring loading chamber of a delivery system, and the rigid ring is generally loaded into the annuloplasty ring loading chamber in a folded structure, but the delivery diameter of the rigid ring in the folded structure is larger, and the size requirement on the annuloplasty ring loading chamber is higher, while the flexible ring has smaller delivery diameter, but has poorer supporting and shaping effects, and mitral regurgitation recurrence easily occurs after operation.
Accordingly, there is a need to design a mitral annuloplasty ring that meets the support strength requirements and delivers a smaller diameter.
Disclosure of Invention
Therefore, the technical problem to be solved by the invention is to overcome the defect that the mitral valve shaping ring in the prior art is difficult to have high supporting strength and small conveying diameter, so as to provide the mitral valve shaping ring.
In order to solve the technical problems, the technical scheme of the invention is as follows:
a mitral valve annuloplasty ring, comprising:
the shrinkage wire has a shape memory function and is 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 wire 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.
Further, the annular structure formed by connecting the multiple sections of the contraction sections end to end is an intermittent annular structure, and the surfaces of two adjacent sections of the contraction sections at the contraction interval are cross sections.
Further, the annular structure formed by connecting the plurality of sections of contraction sections end to end is a complete annular structure, and the adjacent two sections of contraction sections are provided with linking sections at the contraction interval.
Further, the shape of the annular structure formed by connecting the plurality of sections of contraction sections end to end is matched with the physiological structure of the human mitral valve.
Further, the contraction joint is made of a silica gel material.
Further, the shrink wire is made of a memory alloy material.
The shrinkage joint comprises a head end shrinkage joint, a plurality of middle section shrinkage joints and a tail end shrinkage joint which are sequentially arranged, and the head end shrinkage joint is connected with the tail end shrinkage joint through a buckle structure so that the forming ring body forms an annular structure.
Further, the buckle structure comprises a clamping strip arranged on the head end shrinkage section and a buckle arranged on the tail end shrinkage section and buckled with the clamping strip.
Further, the end face of the tail end shrinkage section, which faces the tail end shrinkage section, is a wire collecting end, and the buckle is connected to the wire collecting end.
Further, the end face of the head end shrinkage section, which faces the tail end shrinkage section, is an outgoing line end, one part of the clamping strip is arranged in the inner cavity of the outgoing line end, and the other part of the clamping strip extends outwards from the outgoing line end.
Further, a clamping strip barb is arranged on the outer surface of the clamping strip, a claw is arranged on the inner surface of the buckle, and the clamping strip barb is buckled with the claw.
Further, the clamping strip is arc-shaped or linear.
Further, the end part of the clamping strip, which is positioned in the outgoing line end, is a clamping strip head end, the other end part of the clamping strip, which extends out of the outgoing line end, is a clamping strip tail end, and the clamping strip tail end extends into the buckle.
Further, one end of the shrinkage wire is fixedly connected with the first end of the clamping strip, and the other end of the shrinkage wire is fixedly connected with the buckle.
Further, each section of the contraction section is provided with a guide groove, the contraction wire comprises a guide exposure section which is arranged corresponding to the opening of the guide groove, the guide exposure section is wound with a shaping guide wire, and two end parts of the shaping guide wire extend out of the guide groove and are connected to the conveying system.
Further, the guide groove is arranged on one side of the contraction joint close to the center of the annular structure.
Further, a traction hole is formed in one side of the proximal end of the tail end shrinkage joint, a traction wire is arranged at the tail end of the clamping strip in a penetrating mode, and two end portions of the traction wire are connected to the conveying system after penetrating out of the traction hole.
Further, the surface of each shrinkage section is coated with a coating substrate.
Further, the coating substrate comprises a nickel-titanium alloy net, and the nickel-titanium alloy net comprises a coating section coated on the surface of the shrinkage section and an extension section connected with the coating section and extending outwards in a direction deviating from the center of the annular structure.
Further, the cladding substrate is still including being annular PET screen cloth, the PET screen cloth includes upper PET screen cloth and lower floor's PET screen cloth, upper PET screen cloth with the cladding of lower floor's PET screen cloth is in the surface of nickel titanium alloy net's extension.
Further, the coating substrate further comprises a ring-shaped PET mesh, and the PET mesh is coated on the outer surfaces of the plurality of shrinkage sections and the plurality of nickel-titanium alloy meshes.
Further, the coating substrate further comprises fan-shaped multi-section PET mesh fabrics, and each section of PET mesh fabrics coats the corresponding section of shrinkage section and the outer surface of the nickel-titanium alloy mesh thereon.
Further, the nickel-titanium alloy net is fan-shaped.
Further, the shaped ring body is attached to the native valve leaflet of the human body by rivets passing through the coated substrate.
The technical scheme of the invention has the following advantages:
1. The mitral valve shaping ring comprises a shaping ring body, a plurality of contraction lines and a plurality of contraction joints, wherein the contraction lines have a memory function and are annular in a free state, the contraction joints are of a soft structure, when the shaping ring body passes through a room along with a conveying system and reaches the upper part of a mitral valve, the conveying system is operated to release the shaping ring body, the shaping ring body drives the contraction joints to be connected end to end under the action force of restoring the free form of the contraction lines to form an annular structure, and as the contraction joints are of the soft structure, the physiological activity of the mitral valve ring is closer to that of a normal mitral valve, the coordinated movement of the mitral valve ring can be realized, and as the contraction lines are of a rigid structure and have the memory function, the contraction lines can provide a supporting force for the shaping ring body for maintaining the annular state, so that the shaping ring body can meet the required supporting force requirement.
2. The annular structure formed by connecting the plurality of sections of contraction joints end to end is an intermittent annular structure, when the operation conveying system releases the forming ring body, the contraction joint has small blocking acting force on the contraction wire to recover the free form, and the annular structure which is beneficial to forming the required shape by connecting the contraction joint end to end is realized so as to be matched with the physiological structure of the human mitral valve.
3. The mitral valve shaping ring provided by the invention adopts the contraction joint made of the silica gel material, has better elasticity and good biocompatibility, and can conform to the physiological activities of the mitral valve ring of a human body.
4. According to the mitral valve forming ring provided by the invention, the head end contraction joint and the tail end contraction joint are connected through the buckle structure to enable the forming ring body to form an annular structure, and the buckle structure can increase the stability of the forming ring body after forming the ring and keep the annular shape, so that the support strength of the forming ring body after forming the ring is improved.
5. According to the mitral valve forming ring, the clamping strips on the head end shrinkage joint and the clamping strips on the tail end shrinkage joint are buckled, when the forming ring body is released on the conveying system, the clamping strips and the clamping buckles can be automatically buckled under the action of the shrinkage wire, external force operation is reduced, and smooth operation is facilitated.
6. The clamping strip of the mitral valve forming ring provided by the invention is arc-shaped and is adapted to the radian of the forming ring body, so that the clamping strip can be conveniently inserted into the buckle to automatically realize clamping.
7. The mitral valve shaping ring provided by the invention has the advantages that the guide groove is formed in each contraction section, the shaping guide wire is wound on the guide exposed section of the corresponding guide groove of the contraction wire, the two end parts of the shaping guide wire extend out of the guide groove and are connected to the conveying system, the shaping guide wire is pulled by the conveying system to finely adjust the shape of the shaping ring body after being looped, so that the shaping ring body is shaped, and the shaping ring body is beneficial to forming a ring structure with a required shape after being released.
8. The mitral valve forming ring provided by the invention has the advantages that the traction hole is formed in one side of the proximal end of the tail end contraction section, the traction wire is penetrated through the tail end of the clamping strip, two ends of the traction wire penetrate out of the traction hole and are connected to the conveying system, and the traction wire can be operated to move through the conveying system so as to drive the clamping strip to move into the tail end contraction section, so that the length of the clamping strip extending into the inner part of the clamping buckle can be adjusted, and the connection reliability of the clamping buckle and the clamping strip is further improved.
9. According to the mitral valve forming ring, the surface of the contraction joint is coated with the coating base material, and the forming ring body is connected with the self-body valve leaflet of a human body through the rivet penetrating through the coating base material, so that holes do not need to be drilled on the contraction joint, the coating base material can be used as a base surface for positioning the rivet, the rivet can be driven in conveniently, and the situations that the rivet is positioned inaccurately and repeated damage is caused to biological tissues when the rivet is pulled out are avoided.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are needed in the description of the embodiments or the prior art will be briefly described, and it is obvious that the drawings in the description below are some embodiments of the present invention, and other drawings can be obtained according to the drawings without inventive effort for a person skilled in the art.
FIG. 1 is a perspective view of a mitral valve annuloplasty ring provided in an embodiment of the present invention;
FIG. 2 is a top view of a mitral valve annuloplasty ring provided by an embodiment of the present invention;
FIG. 3 is a schematic view of the wire outlet and wire inlet ends on a mitral valve annuloplasty ring in an embodiment of the present invention;
FIG. 4 is an elevation view of a mitral valve annuloplasty ring provided by an embodiment of the present invention;
FIG. 5 is a cross-sectional view taken along the plane B-B in FIG. 4;
FIG. 6 is a cross-sectional view taken along the A-A plane in FIG. 4;
FIG. 7 is a schematic diagram showing the connection between a wrapping substrate and a shrinkage joint according to the first embodiment of the present invention;
FIG. 8 is a schematic diagram showing the connection between a wrapping substrate and a shrinkage joint according to a second embodiment of the present invention;
FIG. 9 is a schematic diagram showing the connection between a wrapping substrate and a shrinkage joint according to a third embodiment of the present invention;
FIG. 10 is a schematic diagram showing the connection between a wrapping substrate and a shrinkage joint according to a fourth embodiment of the present invention;
FIG. 11 is a diagram of the position of a rivet, forming ring loading chamber on a conveyor system provided by an embodiment of the present invention;
FIG. 12 is a schematic illustration of the physiological anatomy of a human mitral valve;
FIG. 13 is a schematic view of a ring structure formed by connecting multiple sections of the "D" shaped shrinking sections end to end in a fifth embodiment of the invention;
fig. 14 is a schematic view of a complete annular structure formed by connecting multiple sections of contraction joints with each other end to end in a sixth embodiment of the present invention.
The reference numerals are 1, shrinkage joint, 101, shrinkage interval, 102, guide groove, 110, head end shrinkage joint, 111, wire outlet end, 120, middle shrinkage joint, 130, tail end shrinkage joint, 131, wire collecting end, 132, traction hole, 140, clamping strip, 141, clamping strip barb, 142, clamping strip head end, 143, clamping strip tail end, 150, buckle, 151, claw, 160, link section, 2, shrinkage wire, 201, guide exposure section, 3, shaping guide wire, 4, traction wire, 5, coating substrate, 501, nickel titanium alloy net, 502, PET mesh cloth, 6, rivet, 7, forming ring loading cavity, 8, self-body valve blade.
Detailed Description
The following description of the embodiments of the present invention will be made apparent and fully in view of the accompanying drawings, in which some, but not all embodiments of the invention are shown. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
In the description of the present invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," "outer," and the like indicate orientations or positional relationships based on the orientation or positional relationships shown in the drawings, "proximal" refers to an end that is further from the practitioner, "distal" refers to an end that is further from the practitioner, only for convenience in describing the present invention and for simplicity in description, and do not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.
In the description of the present invention, unless explicitly stated or limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected, mechanically connected, electrically connected, directly connected, indirectly connected via an intervening medium, or in communication between two elements. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.
In addition, the technical features of the different embodiments of the present invention described below may be combined with each other as long as they do not collide with each other.
The mitral valve shaping ring comprises a contraction wire 2 and a shaping ring body, wherein the contraction wire 2 has a shape memory function and is annular in a free state, the shaping ring body comprises a plurality of sections of contraction joints 1 which are sleeved on the periphery of the contraction wire 2 in sequence and are of soft structures, the plurality of sections of contraction joints 1 can be connected end to form an annular structure, and a contraction interval 101 is arranged between every two adjacent sections of contraction joints 1.
When the shaping ring body passes through the room space along with the conveying system and reaches the upper part of the mitral valve, the conveying system is operated to release the shaping ring body, the shaping ring body drives the plurality of contraction joints 1 to be connected end to form an annular structure under the action force of the contraction wire 2 for restoring the free form, and the contraction joints 1 are of a soft structure and are close to the physiological activity of the normal mitral valve annulus, so that the coordinated movement with the cardiac cycle can be realized, and the contraction wire 2 is of a rigid structure and has a memory function, so that the contraction wire 2 can provide the shaping ring body with the supporting force for maintaining the annular state, the shaping ring body can meet the required supporting force requirement, and the shaping ring body can be of a straight line shape when being loaded into a loading cavity of the conveying system.
In a specific implementation manner of this embodiment, the shrinkage section 1 includes a head end shrinkage section 110, four sections of middle shrinkage sections 120 and a tail end shrinkage section 130, which are sequentially arranged, and the head end shrinkage section 110 and the tail end shrinkage section 130 are connected through a fastening structure so that the forming ring body forms a ring structure. In alternative embodiments, the number of middle section constrictions 120 may also be 2, 3, 5 or more. The head end shrinkage section 110 and the tail end shrinkage section 130 are connected through the fastening structure to form the annular structure of the forming ring body, so that the stability of the forming ring body in retaining the annular shape after forming the ring can be improved, and the support strength of the forming ring body after forming the ring can be improved.
Specifically, the shrinkage joints 1 are made of silica gel materials, the shrinkage wires 2 are made of nickel-titanium memory alloy materials, and the shrinkage wires 2 are arranged between the multiple shrinkage joints 1 in a penetrating mode. The contraction joint 1 made of the silica gel material has good biocompatibility and elasticity, can conform to the physiological activities of the mitral valve annulus of a human body, and the silica gel contraction joint 1 is a mass production material capable of being produced by injection molding and has the advantages of low production cost and high production efficiency. The nickel-titanium memory alloy has a strong function of recovering the state of the nickel-titanium memory alloy, and is beneficial to forming a forming ring body with an annular structure.
In a specific implementation manner of this embodiment, the annular structure formed by the end-to-end connection of the multiple sections of shrinkage sections 1 is a discontinuous annular structure, the surfaces of the adjacent two sections of shrinkage sections 1 at the shrinkage interval 101 are cross sections, and the annular structure formed by the end-to-end connection of the multiple sections of shrinkage sections 1 is in a shape of a "D" and is matched with the physiological structure of the human mitral valve. When the shaping ring body with the structure is released by operating the conveying system, the obstruction acting force of the contraction joint 1 to the free form recovery of the contraction wire 2 is small, so that the end-to-end connection of the contraction joint 1 to form an annular structure with a required shape is facilitated, and the physiological structure of the human mitral valve is matched. In an alternative embodiment, the annular structure formed by connecting the multiple sections of contraction joints 1 end to end is a complete annular structure, and the adjacent two sections of contraction joints 1 are provided with the link sections 160 at the contraction intervals 101.
In a specific implementation of this embodiment, the fastening structure includes a clip strip 140 disposed in the head end shrinkage section 110 and a fastener 150 disposed on the tail end shrinkage section 130 and engaged with the clip strip 140. The outer surface integrated into one piece of card strip 140 has a plurality of card strip barbs 141 that set up along length direction, and buckle 150 is tubular structure, and the internal surface shaping of buckle 150 has jack catch 151, card strip barb 141 and jack catch 151 looks lock. The buckle structure adopts the structure that the clamping strip 140 on the head end shrinkage joint 110 and the clamping strip 140 of the tail end shrinkage joint 130 are buckled, when the forming ring body is released on the conveying system, under the action of the shrinkage wire 2, the clamping strip 140 and the buckle 150 can be automatically buckled, the external force operation is reduced, and the smooth operation is facilitated. In alternative embodiments, the positions of the catch 150 and the clip strip 140 may be interchanged.
In the present embodiment, the end face of the tail end shrinkage section 130 facing the tail end shrinkage section 130 is specifically a wire winding end 131, and the end face of the head end shrinkage section 110 facing the tail end shrinkage section 130 is specifically a wire outgoing end 111. The clip 150 is connected to the wire receiving end 131, and one part of the clip strip 140 extends into the internal cavity of the wire outlet end 111, and the other part extends out from the wire outlet end 111.
In a specific implementation manner of this embodiment, the clamping strip 140 is arc-shaped, which can adapt to the radian of the forming ring body, so that the clamping strip 140 is beneficial to be inserted into the buckle 150 to be automatically clamped, and further self-locking of the forming ring is realized. The end of the clamping strip 140 located in the wire outlet end 111 is the head end of the clamping strip 140, and the other end of the clamping strip 140 extending out of the wire outlet end 111 is the tail end of the clamping strip 140. One end of the shrinkage wire 2 is fixedly connected with the head end of the clamping strip 140, the other end of the shrinkage wire 2 penetrates out of the head end shrinkage joint 110 and sequentially penetrates through the middle shrinkage joint 120 and the tail end shrinkage joint 130 to be fixedly connected with the clamping buckle 150. In an alternative embodiment, the clamping strip 140 may also be linear, and the other end of the contraction wire 2 may also be fixedly connected with the tail end contraction section 130.
In this embodiment, a guiding slot 102 is formed on one side of each shrinkage section 1 near the center of the annular structure, the portion of the shrinkage wire 2 corresponding to the opening of the guiding slot 102 is a guiding exposed section 201, the guiding exposed section 201 is wound with a shaping guide wire 3, and two ends of the shaping guide wire 3 extend from the guiding slot 102 and are connected to a conveying system. The shaping guide wire 3 is pulled by the conveying system, so that the shape of the shaping ring body after being looped can be finely adjusted, the shaping ring body is shaped, the shaping ring body is favorably released to form an annular structure with a required shape, and the shaping ring is stably connected with the conveying system.
In this embodiment, the proximal end of the tail end contraction section 130 is provided with a traction hole 132, the tail end of the clamping strip 140 is provided with a traction wire 4 in a penetrating manner, and two ends of the traction wire 4 sequentially penetrate out of the tail end of the clamping strip 140 and the traction hole 132 and then are connected to the conveying system. Wherein, the proximal end and the distal end respectively refer to the end near and the end far from the operator. So set up, can operate the motion of haulage line 4 through conveying system, and then drive card strip 140 to tail end shrink section 130 internal motion, can adjust card strip 140 and stretch into the length of buckle 150 internal portion, and then increase buckle 150 and card strip 140's connection reliability to realize the shrink of shaping.
In this embodiment, the surface of each shrinkage joint 1 is coated with a coating substrate 5 matched with the shrinkage joint. The forming ring body is connected with the self-body valve leaflet of the human body through the rivet 6 penetrating through the cladding base material 5, the mode does not need to punch holes in the contraction joint 1, the cladding base material 5 can be used as a base surface for positioning the rivet 6, the rivet 6 can be conveniently driven in, and the problems that the rivet 6 is positioned inaccurately and is easy to fall off are avoided.
In the first implementation of this embodiment, as shown in fig. 7, the coating substrate 5 includes a nickel-titanium alloy net 501, where the nickel-titanium alloy net 501 has a fan shape, and the nickel-titanium alloy net 501 includes a coating section coated on the surface of the shrinkage section 1 and an extension section connected to the coating section and extending outward in a direction away from the center of the ring structure. The nickel-titanium alloy net 501 can maintain the sector surface to be attached to the upper surface of the self-body valve leaflet of the human body under the action of the nickel-titanium alloy net 501, and the extending section of the nickel-titanium alloy net 501 can facilitate the accurate driving of the rivets 6 into the biological tissues of the human body.
In the second implementation manner of this embodiment, as shown in fig. 8, the difference from the first implementation manner is that the wrapping substrate 5 further includes a ring-shaped PET mesh 502, the PET mesh 502 includes an upper PET mesh 502 and a lower PET mesh 502, and the upper PET mesh 502 and the lower PET mesh 502 are wrapped on the outer surface of the extension section of the nitinol mesh 501 by stitching.
In the third implementation of the present embodiment, as shown in fig. 9, the difference from the second implementation is that the PET mesh cloth 502 is wrapped on the outer surfaces of the multi-section shrinkage section 1 and the plurality of nickel-titanium alloy meshes 501.
In the fourth embodiment of the present embodiment, as shown in fig. 10, the difference from the third embodiment is that the wrapping base material 5 has a plurality of segments, each segment of the wrapping base material 5 has a fan shape, a gap is provided between two adjacent segments of the wrapping base material 5, and the length of the portion of each segment of the wrapping base material 5 wrapping the corresponding contraction joint 1 is the same as the length of the contraction joint 1.
In this embodiment, as shown in fig. 11, the structure of the delivery system is that a forming ring loading chamber 7 is provided in the middle of the delivery system, and the forming ring body is loaded into the forming ring loading chamber 7 of the delivery system in a straight line before the operation is performed. The delivery system is further connected to a plurality of rivets 6 located at the outer periphery of the forming ring loading chamber 7 on the end face of the outlet of the forming ring loading chamber 7, the rivets 6 being used to secure the forming ring body to the outer circumferential portion of the native leaflet. Specifically, the rivet 6 penetrates through the upper PET mesh cloth 502, the nickel titanium alloy mesh 501, the lower PET mesh cloth 502 and the self valve leaflet from top to bottom in sequence. The upper end of the rivet 6 is hung on the PET mesh 502 and the nickel titanium alloy 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 self-leaflet through the barb-shaped structure. After the forming ring body is preliminarily formed through the shrinkage wire 2, corresponding rivets 6 are driven into the forming ring body to form an annular structure with a required shape.
Specifically, as shown in fig. 1-10, the annular structure formed by connecting the plurality of contraction sections 1 of the mitral valve forming ring end to end has a circular ring shape matched with the physiological structure of the human mitral valve;
In the embodiment, as shown in the physiological anatomical schematic diagram of the human mitral valve in FIG. 12, the physiological structure of the human mitral valve is approximate to a shape of a "D", wherein the edge of the A region (comprising A1, A2 and A3) is approximate to the straight edge of the shape of the "D", and the edge of the P region (comprising P1, P2 and P3) is approximate to the arc edge of the shape of the "D";
In a fifth implementation manner of the present embodiment, as shown in fig. 13, in order to be closer to the physiological structure of the human mitral valve, in a preferred embodiment, the annular structure formed by connecting the plurality of contraction sections 1 end to end has a shape of "D" that matches with the physiological structure of the human mitral valve, specifically, at least one of the plurality of contraction sections 1 is a linear contraction section, the linear contraction section is correspondingly matched with the edge of the area a of the physiological structure of the human mitral valve, and the other contraction sections 1 are adhered to the edge of the area P of the physiological structure of the human mitral valve;
In a sixth implementation manner of this embodiment, as shown in fig. 14, the annular structure formed by connecting the multiple sections of the contraction sections 1 end to end is a complete annular structure, and the adjacent two sections of the contraction sections 1 are provided with link sections 160 at the contraction intervals, specifically, the link sections 160 make the adjacent contraction sections 1 always spaced a certain distance, and in operation, after the shaping ring body is fixed with the self-leaflet 8, the link sections 160 are compressed only when the traction wire 4 is pulled, and in the compression process, the link sections are bent outwards to form an omega shape, and the shaping ring body forms an annular structure similar to that of the above embodiment.
The mitral valve shaping ring works on the principle that before the operation is performed, the shaping ring body is adjusted to be linearly loaded into the shaping ring loading cavity 7 of the conveying system, and then the shaping ring sequentially comprises a buckle 150, a tail end contraction joint 130, four middle contraction joints 120 and a head end contraction joint 110 along the direction from the proximal end to the distal end. When the conveying system passes through the room septum and reaches the upper part of the mitral valve, the conveying system is operated to release the shaping ring body, the shaping ring body is preliminarily formed into a ring shape under the action of the contraction wire 2 made of nickel-titanium alloy, and the shaping ring body is shaped under the fine adjustment operation of the shaping guide wire 3. The surface of the contraction joint 1 is coated with a nickel-titanium alloy net 501 and a PET net cloth 502, a sector surface is maintained under the action of the nickel-titanium alloy net 501 to be attached to the upper surface of a self-body valve leaflet of a human body, a plurality of rivets 6 are penetrated through an operation conveying system, sequentially pass through the upper PET net cloth 502, the nickel-titanium alloy net 501, the lower PET net cloth 502 and the self-body valve leaflet of the human body, and finally, a forming ring and the self-body valve leaflet are fixed through barbs or barbs of the conveying system.
After the forming ring body and the self-body valve leaf are fixed, the clamping strip 140 is inserted towards the clamping buckle 150 by pulling the traction wire 4 until the forming ring is contracted to a required size, and the clamping claw 151 of the clamping buckle 150 and the clamping strip barb 141 are mutually locked to finish contraction. When the conveying system is disconnected, one end of each traction wire 4 is cut off, and the other end is pulled to be recovered.
In summary, the mitral valve shaping ring provided by the embodiment of the invention comprises the annular contraction wire 2 with a memory function and in a free state and a plurality of contraction joints 1 with a soft structure, when the shaping ring body passes through a room space along with a conveying system and reaches above the mitral valve, the conveying system is operated to release the shaping ring body, the shaping ring body drives the plurality of contraction joints 1 to be connected end to form an annular structure under the acting force of the contraction wire 2 to restore the free state, and the contraction joint 1 is in a soft structure and is closer to the physiological activity of the normal mitral valve annulus, so that the coordinated movement with the cardiac cycle can be realized, and the contraction wire 2 is in a rigid structure and has the memory function, so that the contraction wire 2 can provide the supporting force for the shaping ring body to keep the annular state, thereby the shaping ring body can meet the required supporting force requirement, and when the shaping ring body is installed in a loading cavity of the conveying system, the shaping ring body with a straight line shape, and compared with the shaping ring body with the existing folding structure, the conveying diameter is smaller, and the implantation of the mitral valve shaping ring is facilitated.
It is apparent that the above examples are given by way of illustration only and are not limiting of the embodiments. Other variations or modifications of the above teachings will be apparent to those of ordinary skill in the art. It is not necessary here nor is it exhaustive of all embodiments. While still being apparent from variations or modifications that may be made by those skilled in the art are within the scope of the invention.