CN116549180A

CN116549180A - Heart valve annuloplasty ring implantation system

Info

Publication number: CN116549180A
Application number: CN202310060580.2A
Authority: CN
Inventors: 杨柳; 曹毅; 陈卓; 古乙伶
Original assignee: Beijing Puhui Biomedical Engineering Co ltd
Current assignee: Beijing Puhui Biomedical Engineering Co ltd
Priority date: 2023-01-19
Filing date: 2023-01-19
Publication date: 2023-08-08

Abstract

The invention relates to the technical field of medical equipment, in particular to a heart valve annuloplasty ring implantation system, which comprises: the forming ring comprises a forming ring body, wherein the forming ring body comprises an annular main body which is arranged in a chain structure; the ring holder comprises a ring holding part, wherein the ring holding part comprises a shell and a ring holding sleeve member movably arranged at the lower end of the shell, the ring holding sleeve member comprises a limiting block, a movable connecting part arranged at the upper end of the limiting block and a plurality of supporting rods arranged at the periphery of the lower end of the limiting block, the tail ends of the supporting rods are provided with ring holding parts, and the shell is provided with an operation assembly; when the movable connecting part moves downwards, the support rods drive the ring holding piece to extend outwards. The invention can be adapted to a plurality of sizes of forming ring bodies; the expansion of the valve ring is not caused, and the influence of the annular main body on the contraction period of the valve ring is eliminated; the operation is simple and quick; the utility model is convenient for doctors to observe and use, provides more operation fields and is more suitable for small incision operation.

Description

Heart valve annuloplasty ring implantation system

Technical Field

The invention relates to the technical field of medical equipment, in particular to a heart valve forming ring implantation system.

Background

In prosthetic heart annuloplasty ring implantation procedures, the observation of changes in leaflet shape and position is a key factor affecting the quality of the procedure. However, the connecting part of the handle of the annuloplasty ring holder of the artificial heart valve may obstruct the surgical field of the operator, become a blind area, and are inconvenient for the operator to observe and adjust the anterior leaflet, thereby affecting the surgical effect. The artificial heart valve forming ring is made of a metal frame, silica gel, polyester threads and polyester cloth. For most patients in need of prosthetic heart valves, surgical procedures are used to implant the prosthetic heart valve annuloplasty ring into the body. During the surgical procedure, the surgeon may suture the annuloplasty ring to the tissue of the human body with the aid of the prosthetic heart annuloplasty ring holder holding the annuloplasty ring.

In the systolic and diastolic cycles of the heart, unidirectional flow of blood is achieved by means of four heart valves, respectively: mitral valve, tricuspid valve, aortic valve and pulmonary valve. When the mitral valve and tricuspid valve are closed, the aortic valve and pulmonary valve are opened, blood in the left ventricle flows into the aorta, and blood in the ventricle is prevented from flowing back to the atrium, so that the mitral valve and tricuspid valve play a role of a one-way valve. Taking the mitral valve as an example, when the mitral valve is diseased, the leaflets fail to close properly and the annulus dilates, which can cause blood to flow back from the left ventricle to the left atrium. Mitral regurgitation may reduce cardiac output and ejection fraction, and thus the end diastole volume and pressure of the left ventricle increase significantly, and patients may develop pulmonary hypertension and heart failure, ultimately leading to death.

A common treatment for mitral regurgitation is valvuloplasty. The surgeon repairs the morphology of the damaged heart valve under extracorporeal circulation, correcting the enlarged annulus, thereby treating mitral regurgitation. To maintain long-term therapeutic effect, after annuloplasty, surgeons often implant a prosthetic annuloplasty ring at the patient's annulus to ensure good shaping of the native annulus, while preventing further enlargement of the annulus to maintain therapeutic effect.

The existing forming rings in clinic mainly relate to soft rings, hard rings and semi-hard rings.

The soft ring is usually made of high polymer materials, is not beneficial to the effective closing of valve leaflets and the shaping of the valve ring, can not effectively recover the physiological structure of the heart valve, and has the problem of re-expansion in long term.

The hard ring is made of metal, has better ring body supporting strength, but the physiological curvature of the valve ring changes along with the opening and closing movement process of the mitral valve leaf, the appearance design of the existing part of products tends to conform to the three-dimensional saddle shape of the physiological curvature, but the hard ring is not easy to bend, and the change of the physiological curvature of the valve ring in the cardiac cycle cannot be realized.

The semi-rigid ring body can be rigidly adjusted, so that certain supporting strength is maintained, and curvature change between the front ring and the rear ring is met to a certain degree. From the design concept perspective, the semi-hard ring compromises the product characteristics of the soft ring and the hard ring, can prevent long-term re-expansion, and can maintain certain physiological curvature.

Currently, a semi-hard ring mainly adopts a metal ring body structure, and the purpose of adjustable hardness is realized by adding or removing materials at certain parts (as shown in fig. 13). The design seems to satisfy the 'ring body supporting strength' and the 'good adaptation physiological curvature', and the balance needs to be made among the two characteristics, if the supporting strength is ensured, the ring body cannot be designed to be too soft, and when the mitral valve is contracted, the hardness of the ring body generates certain reverse obstruction, so that the physiological curvature adaptability is sacrificed to a certain extent.

In summary, as a repair device, the annuloplasty ring needs to have two basic properties: 1. the ring body provides enough strength to prevent the valve ring from expanding; 2. the ring body is soft enough to adapt to physiological curvature in the systolic period. Obviously, two opposite purposes are achieved through the characteristics of the material, and the optimal effect is difficult to achieve.

During heart surgery, an operator can place the annuloplasty ring into the patient by means of a prosthetic heart annuloplasty ring holder, and adjust the position of the annuloplasty ring by the annuloplasty ring holder, so as to conveniently suture the annuloplasty ring with human tissue. Wherein, in order to facilitate the operation of the operator, a handle is required to be connected with the artificial heart valve annuloplasty ring holder, so that the operator can adjust the position of the artificial heart valve annuloplasty ring holder by holding the handle. The existing ring holder has complex structure and more components, and affects the vision of doctors; in addition, most clinical ring holders use transparent materials, which can indirectly affect the surgical field due to problems such as refraction or reflection of light.

Disclosure of Invention

The invention provides a heart valve annuloplasty ring implantation system which can adapt to annuloplasty ring bodies with various sizes aiming at the problems in the prior art; the annular main body has certain structural rigidity strength, so that the heart valve is prevented from being expanded again, and meanwhile, the annular main body has certain angle adjustment adaptability, so that the annular main body is released in the systolic period, the expansion of the valve annulus can not be caused, and the influence of the annular main body on the systolic period of the valve annulus is eliminated; the operation is simple and quick, the improvement of the operation efficiency and the operation stability is facilitated, the structure is novel, and the design is ingenious; the invention is in a hollowed-out state in a large area, is convenient for doctors to observe and use, provides more operation fields and is more suitable for small incision operation.

In order to solve the technical problems, the invention adopts the following technical scheme:

the present invention provides a heart annuloplasty ring implant system, comprising:

the forming ring comprises a forming ring body, wherein the forming ring body comprises an annular main body which is arranged in a chain structure; the annular main body comprises a front annular section and a rear annular section, and transition annular sections are connected between two ends of the front annular section and two ends of the rear annular section;

the ring holder comprises a ring holding part, wherein the ring holding part comprises a shell and a ring holding sleeve member movably arranged at the lower end of the shell, the ring holding sleeve member comprises a limiting block, a movable connecting part arranged at the upper end of the limiting block and a plurality of supporting rods arranged at the periphery of the lower end of the limiting block, and the supporting rods are arranged in a strip-shaped structure; the tail end of the supporting rod is provided with a ring holding piece matched with the annular main body, the ring holding piece is used for connecting the inner side wall of the annular main body, the movable connecting part is movably connected with the shell, and the shell is provided with an operation assembly for driving the movable connecting part to move and lock; when the movable connecting part moves downwards, the support rods drive the ring holding piece to extend outwards.

Wherein the support rod is made of shape memory metal; the lower end of the shell is provided with a plurality of holding ring guide holes, the support rods are in one-to-one correspondence with the holding ring guide holes, and the support rods movably penetrate through the holding ring guide holes; the limiting block is arranged in the shell in a limiting sliding manner.

Wherein the movable connecting part is a connecting screw rod; a movable inner hole which is movably connected with the connecting screw rod is arranged in the shell;

the operation assembly comprises a rotating rod and a fixed bolt, one side of the shell is provided with a rotating hole and a bolt guide hole, the rotating hole is rotationally connected with the rotating rod, the fixed bolt is movably inserted into the bolt guide hole, and the bolt guide hole and the rotating hole are respectively communicated with the movable inner hole;

the rotating rod is used for driving the movable connecting part to move up and down; the fixed bolt is used for locking and fixing the movable connecting part.

The rotary rod is characterized in that a first holding end part is arranged at one end of the rotary rod, a gear part is arranged on the periphery of the rotary rod, and the gear part is in meshed transmission connection with the connecting screw rod.

The fixing bolt comprises a fixing bolt body and is characterized in that one end of the fixing bolt body is provided with a second holding end part, the front end of the fixing bolt body is provided with a passing section, the middle part of the fixing bolt body is provided with a limiting section, a limiting piece is arranged between the limiting section and the second holding end part, and the periphery of the limiting section is provided with a limiting structure used for clamping a connecting screw.

The ring holder further comprises a handle part, a handle connecting hole is formed in the top end of the shell, the handle part comprises a handle and a connecting rod connected to the lower end of the handle, and the lower end of the connecting rod is connected with the handle connecting hole.

The annular main body comprises a front annular section and a rear annular section, and transition annular sections are connected between two ends of the front annular section and two ends of the rear annular section;

the front ring section and the rear ring section each comprise a main body tube;

the transition ring segment comprises a plurality of first connecting pieces which are connected in sequence; two adjacent first connecting pieces are movably connected; the two ends of the main body pipe are respectively and movably connected with adjacent first connecting pieces, one end of each first connecting piece is provided with a first limit connecting block, the other end of each first connecting piece is provided with a first limit connecting groove, the first limit connecting blocks are rotatably arranged in the first limit connecting grooves, and a first movable gap is arranged between each first limit connecting block and each first limit connecting groove;

the front ring section and the rear ring section both comprise connecting components which are movably connected to one end or/and two ends of the main body pipe, the connecting components comprise at least one second connecting piece, one end of the second connecting piece is movably connected with the main body pipe, and the other end of the second connecting piece is connected with the adjacent first connecting piece;

one end of the second connecting piece and one end of the main body pipe are both provided with second limiting connecting blocks, the other end of the second connecting piece and the other end of the main body pipe are both provided with second limiting connecting grooves, and the second limiting connecting blocks are rotationally arranged in the second limiting connecting grooves.

The first limit connecting block can form a movable included angle alpha of 1-5 degrees relative to the first limit connecting groove.

Wherein the annular main body is made of metal; the outer periphery of annular main part cladding has the extension bed of material, the periphery cladding of extension bed of material has the knitting layer, one side of knitting layer is provided with the sewing up position.

Preferably, the extension material layer is a silica gel layer, and the thickness of the silica gel layer is 0.2 mm-1 mm; the braided fabric layer is a polymer braided net structure, the mesh thickness of the polymer braided net structure is 0.1-0.3 mm, and the thickness of the braided fabric layer is 0.3-1 mm.

The invention has the beneficial effects that:

when the ring-shaped ring is used, a doctor drives the movable connecting part to move up and down through the operation assembly, so that the ring-shaped sleeve is driven to move up and down, the support rod and the ring-shaped sleeve are driven to move up and down, the position and the size of the ring-shaped main body are convenient to adjust during the operation of the doctor, and the ring-shaped ring can be adapted to the forming ring bodies with various sizes; the annular main body is arranged in a chain structure, so that the annular main body has certain structural rigidity strength, the heart valve is prevented from being expanded again through the strength of the annular main body, meanwhile, the annular main body is provided with certain angle adjustment adaptive capacity, the annular main body is released in the systolic period, the expansion of the valve annulus cannot be caused, and the influence of the annular main body on the systolic period of the valve annulus is eliminated; the invention has simple and quick operation, is beneficial to improving the operation efficiency and the operation stability, and has novel structure and ingenious design; the invention is in a hollowed-out state in a large area, is convenient for doctors to observe and use, provides more operation fields and is more suitable for small incision operation.

Drawings

Fig. 1 is a schematic structural diagram of the cooperation between the forming ring body and the ring holder according to embodiment 1.

Fig. 2 is a schematic view of another view angle structure of the cooperation between the forming ring body and the ring holder according to embodiment 1.

Fig. 3 is a schematic structural view of the ring holder of embodiment 1.

Fig. 4 is a schematic structural view of the handle member of embodiment 1.

Fig. 5 is a schematic structural diagram of the ring holder set of embodiment 1.

Fig. 6 is a schematic structural view of the case of embodiment 1.

Fig. 7 is a schematic structural diagram of the fixing bolt of embodiment 1.

Fig. 8 is a schematic structural view of a rotating lever of embodiment 1.

Fig. 9 is a schematic structural view of the ring holder of embodiment 1 in a contracted state.

Fig. 10 is a schematic structural diagram of the holding ring set of embodiment 1 after hiding the housing.

Fig. 11 is a cross-sectional view of the grip ring assembly of example 1.

Fig. 12 is a schematic structural diagram of the fixing latch and the movable connection part of embodiment 1.

FIG. 13 is a schematic diagram of a prior art semi-rigid ring.

Fig. 14 is a schematic structural view of the forming ring body of embodiment 1.

Fig. 15 is a schematic cross-sectional structure of the forming ring body of embodiment 1.

Fig. 16 is a schematic view showing the structure of the molded ring body of example 1 after concealing the partially stretched layer and the braid layer.

Fig. 17 is a schematic view of the structure of the molded ring body of example 1 after concealing the extensible layer and the braid layer.

Fig. 18 is a schematic structural diagram of the mating connection between the plurality of second connectors in embodiment 1.

Fig. 19 is a schematic structural view of the mating connection between the first connectors in embodiment 1.

Fig. 20 is a schematic structural diagram of the first limit connection block and the first limit connection groove of embodiment 1.

Fig. 21 is a schematic structural view of the first connector of embodiment 2.

Fig. 22 is a structural exploded view of the first connector of embodiment 2.

Fig. 23 is a schematic structural view of a ring holder set of embodiment 3.

Fig. 24 is a cross-sectional view of the grip ring assembly of example 3.

Fig. 25 is a schematic structural view of a turning handle of embodiment 3.

Fig. 26 is a schematic view showing the structure of the holding ring set of embodiment 3 after hiding the housing and turning the handle.

Fig. 27 is a schematic structural view of the case of embodiment 3.

Fig. 28 is a schematic structural view of the support rod of embodiment 4.

Fig. 29 is a schematic view of the configuration of the retainer ring of example 4 mated with an external heart valve annuloplasty ring.

Fig. 30 is a schematic structural view of the ring holder of embodiment 4.

The reference numerals in fig. 1 to 30 include:

100. a ring holding member; 200. a handle member; 300. forming a ring body;

1. a front ring segment; 2. a rear ring segment; 3. a transition ring segment; 4. a main body tube; 5. a first connector; 6. a second connector; 7. the first limit connecting block; 8. the first limit connecting groove; 9. the second limit connecting block; 10. the second limit connecting groove; 11. extending a material layer; 12. a braid layer; 13. a suture site; 14. a main connection part; 15. a secondary connection portion; 16. a positioning structure portion; 17. a positioning cavity; 18. a positioning arm;

101. a housing; 102. a limiting block; 103. a movable connection part; 104. a support rod; 105. a ring holder; 106. a rotating lever; 107. fixing the bolt; 108. a rotation hole; 109. a pin guide hole; 110. a first gripping end; 111. a gear portion; 112. a second gripping end; 113. a pass section; 114. a limiting section; 115. a limiting piece; 116. a handle connection hole; 117. a connecting rod; 118. a holding ring guide hole; 119. a clamping component; 120. a clamping hole; 121. a bonding groove; 122. a clamping block; 123. rotating the handle; 124. rotating the screw hole; 125. an external thread section; 126. a clamping groove; 127. a handle.

Detailed Description

The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. 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 fall within the scope of the invention. It is to be understood that the drawings are designed solely for the purposes of illustration and not as a definition of the limits of the invention. The connection relationships shown in the drawings are for convenience of clarity of description only and are not limiting on the manner of connection.

It is noted that when one component is considered to be "connected" to another component, it may be directly connected to the other component, or intervening components may also be present. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. It should also be noted that the terms "mounted," "connected," and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected, unless otherwise specifically defined and limited; either mechanically or electrically, or by communication between two components. 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. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

It should be further noted that, in the description of the present invention, it should be noted that, directions or positional relationships indicated by terms such as "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., are based on directions or positional relationships shown in the drawings, are merely for convenience of describing the present invention and simplifying the description, and do not indicate or imply that the apparatus or elements referred to must have a specific direction, be configured and operated in the specific direction, and thus 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.

Example 1

A heart annuloplasty ring implant system, as shown in fig. 1-20, comprising:

a forming ring body 300 including an annular main body arranged in a chain structure;

the ring holder comprises a ring holding component 100, wherein the ring holding component 100 comprises a shell 101 and a ring holding sleeve member movably arranged at the lower end of the shell 101, the ring holding sleeve member comprises a limiting block 102, a movable connecting part 103 arranged at the upper end of the limiting block 102 and a plurality of supporting rods 104 arranged at the periphery of the lower end of the limiting block 102, and the supporting rods 104 are preferably made of shape memory metal; the tail end of the supporting rod 104 is provided with a holding ring piece 105 matched with the annular main body, the holding ring piece 105 is used for abutting against the inner side wall of the annular main body, and the supporting rod 104 and the holding ring piece 105 are integrally arranged or fixedly connected with each other; the movable connecting part 103 is movably connected with the shell 101, and the shell 101 is provided with an operation component for driving the movable connecting part 103 to move and lock; the lower end of the shell 101 is provided with a plurality of holding ring guide holes 118, the support rods 104 are in one-to-one correspondence with the holding ring guide holes 118, and the support rods 104 movably penetrate through the holding ring guide holes 118; the limiting block 102 is arranged in the shell 101 in a limiting sliding manner, so that the stability of up-and-down movement of the ring holding sleeve member is improved; under the action of the holding ring guide holes 118, the moving accuracy of the support rod 104 is ensured; when the movable connecting portion 103 moves downward, the plurality of support rods 104 drive the ring holding members 105 to extend outwards.

Specifically, when the embodiment 1 is used, a doctor drives the movable connecting part 103 to move up and down through the operation assembly, so as to drive the ring holding sleeve member to move up and down, and drive the support rod 104 and the ring holding member 105 to move up and down, so that the doctor can conveniently adjust the position and the size of the annular main body during operation, and can adapt to the forming ring body 300 with various sizes; the annular main body is arranged in a chain structure, so that the annular main body of the embodiment has certain structural rigidity strength, and the heart valve is prevented from being expanded again through the strength of the annular main body; the embodiment is simple and quick to operate, is beneficial to improving the operation efficiency and the operation stability, and is novel in structure and ingenious in design; because the supporting rod 104 is in a strip structure, the shell 101 is vertically arranged, so that the embodiment is in a hollowed-out state in a large area, and is convenient for doctors to observe and use, provides more operation fields, and is more suitable for small incision operation.

In this embodiment, the movable connection portion 103 is a connection screw; a movable inner hole which is movably connected with the connecting screw rod is arranged in the shell 101; the operation assembly comprises a rotating rod 106 and a fixed plug 107, one side of the shell 101 is provided with a rotating hole 108 and a plug guide hole 109, the rotating hole 108 is rotationally connected with the rotating rod 106, the fixed plug 107 is movably inserted into the plug guide hole 109, and the plug guide hole 109 and the rotating hole 108 are respectively communicated with the movable inner hole; the rotating rod 106 is used for driving the movable connecting part 103 to move up and down; the fixing latch 107 is used for locking and fixing the movable connection part 103.

Preferably, the latch guide hole 109 and the rotation hole 108 are both horizontally arranged, and the connecting screw is vertically arranged.

In this embodiment, a first holding end 110 is provided at one end of the rotation lever 106, a gear portion 111 is provided at the outer periphery of the rotation lever 106, and the gear portion 111 is engaged with the connecting screw for transmission. Specifically, when the rotation lever 106 is rotated, the rotation of the gear portion 111 drives the connecting screw to rise or fall.

In this embodiment, one end of the fixing bolt 107 is provided with a second holding end 112, the front end of the fixing bolt 107 is provided with a passing section 113, the middle part of the fixing bolt 107 is provided with a limiting section 114, a limiting piece 115 is arranged between the limiting section 114 and the second holding end 112, and the periphery of the limiting section 114 is provided with a limiting structure for clamping the connecting screw. Specifically, the fixing bolt 107 is inserted into the bolt guide hole 109, and the limiting structure of the limiting section 114 abuts against the connecting screw rod to prevent the connecting screw rod from rotating, so that the position of the holding ring sleeve member is locked; when the fixing latch 107 is pulled to move outside the housing 101, the limiting section 114 is separated from the connecting screw, the position of the connecting screw is reached through the section 113, and the limiting piece 115 prevents the fixing latch 107 from falling off, so that the structure is reliable.

In this embodiment, the ring holder further includes a handle member 200, where the handle member 200 is disposed vertically; the top end of the housing 101 is provided with a handle connection hole 116, and the handle member 200 includes a grip 127 and a connection rod 117 connected to the lower end of the grip 127, the lower end of the connection rod 117 being connected to the handle connection hole 116. Specifically, the handle connection hole 116 may be a screw hole, and the connection rod 117 may be a screw structure that is matched with the screw hole.

In the embodiment, the ring holder is made of high-temperature-resistant metal and high-molecular materials; the material which can be reused after high-temperature steam sterilization or ethylene oxide sterilization is adopted, so that the reuse is realized, and compared with the existing disposable ring holder, the embodiment can greatly reduce the resource waste.

In this embodiment, the shape of the annular body is saddle-shaped; wherein the annular main body is made of metal; the annular main body is made of metal; the outer periphery of the annular main body is coated with an extension material layer 11, the outer periphery of the extension material layer 11 is coated with a braided fabric layer 12, one side of the braided fabric layer 12 is provided with a sewing position 13, and one side of the braided fabric layer 12 is provided with a sewing position 13; the extension material layer 11 is a silica gel layer, and the thickness of the silica gel layer is 0.2 mm-1 mm; the braided fabric layer 12 is a polymer braided net structure, the mesh thickness of the polymer braided net structure is 0.1-0.3 mm, and the thickness of the braided fabric layer 12 is 0.3-1 mm; the extension material layer 11 and the braided fabric layer 12 can protect the annular main body, the structure is reliable, and on the other hand, abrasion to the heart valve is avoided; wherein, the annular main body is hollow tubular, has consistent outer diameter and diameter range of phi 1-3 mm, and adopts metal with higher strength, such as common metal materials of implantation instruments, such as stainless steel, nickel-titanium alloy, cobalt-chromium alloy and the like.

In the embodiment, the annular main body comprises a front annular section 1 and a rear annular section 2, and a transition annular section 3 is connected between two ends of the front annular section 1 and two ends of the rear annular section 2;

the front ring section 1 and the rear ring section 2 both comprise a main body tube 4;

the transition ring segment 3 comprises a plurality of first connecting pieces 5 which are connected in sequence; two adjacent first connecting pieces 5 are movably connected; two ends of the main body pipe 4 are respectively and movably connected with adjacent first connecting pieces 5, one end of each first connecting piece 5 is provided with a first limit connecting block 7, the other end of each first connecting piece 5 is provided with a first limit connecting groove 8, the first limit connecting blocks 7 are rotatably arranged in the first limit connecting grooves 8, and a first movable gap is arranged between each first limit connecting block 7 and each first limit connecting groove 8;

specifically, the embodiment has novel structure and ingenious design, and under the arrangement, the main body tube 4 plays a role in stabilizing the front ring section 1 and the rear ring section 2, so that the embodiment has certain structural rigidity strength, and the heart valve is prevented from being expanded again through the strength of the annular main body; in addition, the transition ring section 3 is formed by movably connecting a plurality of first connecting pieces 5 which are connected in sequence, so that the embodiment has certain angle adjustment adaptability, the annular main body is released in the systole, the expansion of the valve annulus can not be caused in the systole of the heart valve, and the influence of the annular main body on the systole of the valve annulus is eliminated.

Further, the front ring section 1 and the rear ring section 2 both comprise connecting components movably connected to one end or/and two ends of the main body pipe 4, the connecting components comprise at least one second connecting piece 6, one end of the second connecting piece 6 is movably connected with the main body pipe 4, and the other end of the second connecting piece 6 is connected with the adjacent first connecting piece 5;

a second limit connecting block 9 is arranged at one end of the second connecting piece 6 and one end of the main body pipe 4, a second limit connecting groove 10 is arranged at the other end of the second connecting piece 6 and the other end of the main body pipe 4, and the second limit connecting block 9 is rotatably arranged in the second limit connecting groove 10; a second movable gap is arranged between the second limit connecting block 9 and the second limit connecting groove 10, and the adaptive expansion and contraction of the front ring section 1 and the rear ring section 2 are realized through the second movable gap.

Specifically, one end of the second connecting piece 6 and one end of the main body pipe 4 are both provided with a second limit connecting block 9, the other end of the second connecting piece 6 and the other end of the main body pipe 4 are both provided with a second limit connecting groove 10, and the second limit connecting block 9 is rotatably arranged in the second limit connecting groove 10; of course, the first limit connecting block 7 may be matched with the second limit connecting slot 10, the second limit connecting block 9 may be matched with the first limit connecting slot 8, the first limit connecting block 7 may be movably accommodated in the second limit connecting slot 10 of the adjacent second connecting piece 6, and the second limit connecting block 9 may be movably accommodated in the first limit connecting slot 8 of the adjacent first connecting piece 5; a second movable gap is arranged between the second limit connecting block 9 and the second limit connecting groove 10, and the adaptive expansion and contraction of the front ring section 1 and the rear ring section 2 are realized through the second movable gap.

In this embodiment, the movable included angle α of the first limiting connection block 7 with respect to the first limiting connection groove 8 is 1 ° to 5 °. The rotatable angle between each first connecting piece 5 is 1-5 deg.. The second limit connecting block 9 can form a movable included angle alpha of 1-5 degrees relative to the second limit connecting groove 10; specifically, the rotatable angle between each second connection member 6 is 1 to 5 °.

The first limit connecting block 7 and the second limit connecting block 9 can be in a sphere shape, an elliptic sphere shape or a polygonal shape, and after two adjacent first connecting pieces 5 are mutually locked, due to the structure of the first movable gap and the second movable gap, the two adjacent first connecting pieces can relatively move, so that the ring body strength of the annular main body is ensured, the heart valve is prevented from being expanded again, the heart valve can adapt to the systole of the heart valve, the pressure of the annular main body is released in the systole, and the influence of the formed annular body on the systole of the valve annulus is eliminated.

Example 2

This embodiment 2 differs from embodiment 1 in that: as shown in fig. 21 to 22, the first connecting member 5 includes a main connecting portion 14, a secondary connecting portion 15 and a positioning structure portion 16, a positioning cavity 17 is formed at the rear end of the main connecting portion 14, two positioning arms 18 are disposed at the front end of the secondary connecting portion 15, the main connecting portion 14 and the secondary connecting portion 15 are hollow, the positioning structure portion 16 is inserted into the secondary connecting portion 15 and the upper main connecting portion 14, the positioning structure portion 16 is located between the two positioning arms 18, and the positioning structure portion 16 is used for pushing up the two positioning arms 18 so that the positioning arms 18 are clamped in the positioning cavity 17. Specifically, the positioning arm 18 at the front end of the auxiliary connecting portion 15 extends into the positioning cavity 17, the positioning structure portion 16 is inserted between the main connecting portion 14 and the auxiliary connecting portion 15 from a hollow position, the two positioning arms 18 are pushed open so that the positioning arms 18 abut against the inner wall of the positioning cavity 17, and the main connecting portion 14 and the auxiliary connecting portion 15 are locked through the positioning arms 18.

Furthermore, the opening direction of the main connecting portion 14 can be designed to be inclined at a certain angle according to the actual requirement, so that the moving angle of the first connecting member 5 can be controlled in a specific direction and range.

In this embodiment 2, the rear end of the main connecting portion 14 is provided with an opening, the opening is communicated with the positioning cavity 17, the opening is convenient for the positioning arm 18 of the auxiliary connecting portion 15 to extend into the positioning cavity 17, preferably, the positioning cavity 17 is a circular cavity or an oval cavity, the positioning arm 18 is provided with a semicircular protruding block, the semicircular protruding block is matched with the inner wall of the positioning cavity 17 in shape and is used for being abutted with the inner wall of the circular cavity or the oval cavity, positioning effect between the positioning arm 18 and the positioning cavity 17 is guaranteed, and the structure is reliable.

Of course, the structure of the second connecting member 6 is also identical to that of the first connecting member 5 of embodiment 2, and the specific principle and structure are as above, which is not repeated here.

Example 3

This embodiment 3 differs from embodiment 1 in that: as shown in fig. 23 to 27, a clamping block 122 is arranged at the top of the movable connecting part 103, the operation assembly comprises a rotary handle 123, a rotary screw hole 124 rotationally connected with the rotary handle 123 is arranged at the top end of the shell 101, and an external thread section 125 in threaded connection with the rotary screw hole 124 in a matching manner is arranged on the peripheral wall of the lower end of the rotary handle 123; the lower end of the rotary handle 123 is provided with a clamping groove 126 which is matched and clamped with the clamping block 122. Specifically, in this arrangement, the handle member 200 of embodiment 1 is omitted, and by screwing the rotary handle 123, the movable connecting portion 103 can be driven to move up and down by the external thread section 125 and the rotary screw hole 124 being screwed together, so that the operation is simple and the use is convenient.

Example 4

This embodiment 4 differs from embodiment 1 in that: as shown in fig. 28 to 30, the end of the support rod 104 is detachably connected to the ring holding member 105, and the detachable connection can be realized by conventional screw and screw hole matching. Preferably, the tail end of the supporting rod 104 is provided with a clamping part 119, the back surface of the ring holding piece 105 is provided with a clamping hole 120 matched and clamped with the clamping part 119, the front end surface of the ring holding piece 105 is provided with a fitting groove 121 which is fitted with an external heart valve forming ring, and the fitting groove 121 can be more fitted with the outer wall of the external heart valve forming ring, so that the stability of the ring holding of the embodiment is improved, and the structure is reliable; further, the clamping component 119 includes two elastic clamping arms opposite to each other, the outer side walls of the elastic clamping arms are provided with clamping convex bodies, the two elastic clamping arms are inserted into the clamping holes 120, and the clamping convex bodies abut against the inner walls of the clamping holes 120 under the action of the elastic clamping arms, so that locking between the ring holding piece 105 and the support rod 104 is achieved.

The present invention is not limited to the preferred embodiments, but is intended to be limited to the following description, and any modifications, equivalent changes and variations in light of the above-described embodiments will be apparent to those skilled in the art without departing from the scope of the present invention.

Claims

1. A heart annuloplasty ring implant system, comprising:

a forming ring body (300) comprising an annular main body arranged in a chain-type structure; the annular main body comprises a front annular section (1) and a rear annular section (2), and a transition annular section (3) is connected between two ends of the front annular section (1) and two ends of the rear annular section (2);

the ring holder comprises a ring holding component (100), wherein the ring holding component (100) comprises a shell (101) and a ring holding sleeve member movably arranged at the lower end of the shell (101), the ring holding sleeve member comprises a limiting block (102), a movable connecting part (103) arranged at the upper end of the limiting block (102) and a plurality of supporting rods (104) arranged at the periphery of the lower end of the limiting block (102), and the supporting rods (104) are arranged in a strip-shaped structure; the tail end of the supporting rod (104) is provided with a ring holding piece (105) matched with the annular main body, the ring holding piece (105) is used for connecting the inner side wall of the annular main body, the movable connecting part (103) is movably connected with the shell (101), and the shell (101) is provided with an operation assembly for driving the movable connecting part (103) to move and lock; when the movable connecting part (103) moves downwards, the plurality of support rods (104) drive the ring holding piece (105) to extend outwards.

2. A heart annuloplasty ring implant system according to claim 1, wherein: the support rod (104) is made of shape memory metal; the lower end of the shell (101) is provided with a plurality of holding ring guide holes (118), the support rods (104) are in one-to-one correspondence with the holding ring guide holes (118), and the support rods (104) movably penetrate through the holding ring guide holes (118); the limiting block (102) is arranged in the shell (101) in a limiting sliding manner.

3. A heart annuloplasty ring implant system according to claim 1, wherein: the movable connecting part (103) is a connecting screw rod; a movable inner hole which is movably connected with the connecting screw rod is arranged in the shell (101);

the operation assembly comprises a rotating rod (106) and a fixed plug pin (107), one side of the shell (101) is provided with a rotating hole (108) and a plug pin guide hole (109), the rotating hole (108) is rotationally connected with the rotating rod (106), the fixed plug pin (107) is movably inserted into the plug pin guide hole (109), and the plug pin guide hole (109) and the rotating hole (108) are respectively communicated with the movable inner hole;

the rotating rod (106) is used for driving the movable connecting part (103) to move up and down; the fixed bolt (107) is used for locking and fixing the movable connecting part (103).

4. A heart annuloplasty ring implant system according to claim 1, wherein: one end of the rotating rod (106) is provided with a first holding end part (110), the periphery of the rotating rod (106) is provided with a gear part (111), and the gear part (111) is in meshed transmission connection with the connecting screw.

5. A heart annuloplasty ring implant system according to claim 1, wherein: one end of the fixed plug (107) is provided with a second holding end part (112), the front end of the fixed plug (107) is provided with a passing section (113), the middle part of the fixed plug (107) is provided with a limiting section (114), a limiting piece (115) is arranged between the limiting section (114) and the second holding end part (112), and the periphery of the limiting section (114) is provided with a limiting structure for clamping the connecting screw.

6. A heart annuloplasty ring implant system according to claim 1, wherein: the ring holder further comprises a handle part (200), a handle connecting hole (116) is formed in the top end of the shell (101), the handle part (200) comprises a handle (127) and a connecting rod (117) connected to the lower end of the handle (127), and the lower end of the connecting rod (117) is connected with the handle connecting hole (116).

7. A heart annuloplasty ring implant system according to claim 1, wherein: the front ring section (1) and the rear ring section (2) both comprise a main body tube (4);

the transition ring section (3) comprises a plurality of first connecting pieces (5) which are connected in sequence; two adjacent first connecting pieces (5) are movably connected; the two ends of the main body pipe (4) are respectively and movably connected with adjacent first connecting pieces (5), one end of each first connecting piece (5) is provided with a first limit connecting block (7), the other end of each first connecting piece (5) is provided with a first limit connecting groove (8), the first limit connecting blocks (7) are rotationally arranged in the first limit connecting grooves (8), and a first movable gap is formed between each first limit connecting block (7) and each first limit connecting groove (8);

the front ring section (1) and the rear ring section (2) comprise connecting components which are movably connected to one end or/and two ends of the main body pipe (4), the connecting components comprise at least one second connecting piece (6), one end of the second connecting piece (6) is movably connected with the main body pipe (4), and the other end of the second connecting piece (6) is connected with an adjacent first connecting piece (5);

one end of the second connecting piece (6) and one end of the main body pipe (4) are both provided with a second limiting connecting block (9), the other end of the second connecting piece (6) and the other end of the main body pipe (4) are both provided with a second limiting connecting groove (10), and the second limiting connecting block (9) is rotationally arranged in the second limiting connecting groove (10).

8. A heart annuloplasty ring implant system according to claim 7, wherein: the first limit connecting block (7) can form a movable included angle alpha of 1-5 degrees relative to the first limit connecting groove (8).

9. A heart annuloplasty ring implant system according to claim 1, wherein: the annular main body is made of metal; the outer periphery of the annular main body is coated with an extension material layer (11), the outer periphery of the extension material layer (11) is coated with a braided fabric layer (12), and one side of the braided fabric layer (12) is provided with a sewing part (13).

10. A heart annuloplasty ring implant system according to claim 9, wherein: the extension material layer (11) is a silica gel layer, and the thickness of the silica gel layer is 0.2 mm-1 mm; the braided fabric layer (12) is a polymer braided net structure, the mesh thickness of the polymer braided net structure is 0.1-0.3 mm, and the thickness of the braided fabric layer (12) is 0.3-1 mm.