CN219126880U

CN219126880U - Annuloplasty ring

Info

Publication number: CN219126880U
Application number: CN202223414981.3U
Authority: CN
Inventors: 杨柳; 陈卓
Original assignee: Beijing Puhui Biomedical Engineering Co ltd
Current assignee: Beijing Puhui Biomedical Engineering Co ltd
Priority date: 2022-12-20
Filing date: 2022-12-20
Publication date: 2023-06-06
Anticipated expiration: 2032-12-20

Abstract

The utility model relates to the technical field of heart valve forming rings, in particular to an annuloplasty ring which comprises an annular main body and a protective layer wrapping the periphery of the annular main body; 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 section comprises at least two first connecting pieces which are connected in sequence; two adjacent first connecting pieces are movably connected; two ends of the main body pipe are respectively and movably connected with the adjacent first connecting pieces. The heart valve has novel structure and certain structural rigidity strength, and the heart valve is prevented from being expanded again through the strength of the annular main body; the utility model has a certain angle adjusting adaptability, realizes the release of the annular main body in the systole, does not cause the expansion of the valve annulus in the systole of the heart valve, and eliminates the influence of the annular main body on the systole of the valve annulus.

Description

Annuloplasty ring

Technical Field

The utility model relates to the technical field of heart valve forming rings, in particular to an valve forming ring.

Background

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.

At present, a semi-hard ring mainly adopts a metal ring body structure, and the aim of adjustable hardness is fulfilled by adding or removing materials at certain parts (shown in figure 1). 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.

Disclosure of Invention

Aiming at the problems in the prior art, the utility model provides an annuloplasty ring which has novel structure and certain structural rigidity strength, and prevents the heart valve from expanding again through the strength of an annular main body; in addition, the transition ring section is formed by movably connecting at least two first connecting pieces which are sequentially connected, so that 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.

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

the utility model provides an annuloplasty ring, which comprises an annular main body and a protective layer wrapping the periphery of the annular main body;

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 section comprises at least two first connecting pieces which are connected in sequence; two adjacent first connecting pieces are movably connected; two ends of the main body pipe are respectively and movably connected with the adjacent first connecting pieces.

The front ring section and the rear ring section respectively comprise a connecting component movably connected to one end or/and two ends of the main body pipe, the connecting component comprises 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.

The one end of first connecting piece is provided with first spacing connecting block, the other end of first connecting piece is provided with first spacing spread groove, first spacing connecting block rotate set up in the first spacing spread groove.

The one end of second connecting piece with the one end of main part pipe all is provided with the spacing connecting block of second, the other end of second connecting piece with the other end of main part pipe all is provided with the spacing spread groove of second, the spacing connecting block of second rotate set up in the spacing spread groove of second.

Wherein the annular main body is made of metal; the protective layer comprises an extension material layer and a braided fabric layer, wherein the extension material layer is coated on the periphery of the annular main body, the braided fabric layer is coated on the periphery of the extension material layer, and one side of the braided fabric layer is provided with a sewing position.

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.

Wherein the annular main body is hollow tubular.

The first connecting piece comprises a main connecting part, an auxiliary connecting part and a positioning structure part, wherein a positioning cavity is formed in the rear end of the main connecting part, two positioning arms which are just opposite to each other are arranged at the front end of the auxiliary connecting part, the main connecting part and the auxiliary connecting part are in hollow states, the positioning structure part is inserted into the auxiliary connecting part and the main connecting part, the positioning structure part is located between the two positioning arms, and the positioning structure part is used for pushing up the two positioning arms so that the positioning arms are clamped in the positioning cavity.

The utility model has the beneficial effects that:

the heart valve has novel structure and ingenious design, and the main body tube plays a role in stabilizing the front ring section and the rear ring section, so that the heart valve 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 is formed by movably connecting at least two first connecting pieces which are sequentially connected, so that 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.

Drawings

FIG. 1 is a schematic diagram of a prior art semi-rigid ring.

Fig. 2 is a schematic structural view of an annuloplasty ring of embodiment 1.

Fig. 3 is a schematic cross-sectional structure of embodiment 1.

Fig. 4 is a schematic structural diagram of embodiment 1 after a part of the protective layer is hidden.

Fig. 5 is a schematic structural diagram of embodiment 1 after concealing the protective layer.

Fig. 6 is a schematic structural diagram of the mating connection between the plurality of second connectors in embodiment 1.

Fig. 7 is a schematic structural diagram of the mating connection between the first connectors in embodiment 1.

Fig. 8 is a schematic structural diagram of the first limit connection block and the first limit connection groove of embodiment 1.

Fig. 9 is a schematic structural view of the first connector of embodiment 2.

Fig. 10 is a structural exploded view of the first connector of embodiment 2.

The reference numerals in fig. 1 to 10 include:

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. positioning arms.

Detailed Description

The following description of the embodiments of the present utility model 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 utility model, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the utility model without making any inventive effort, are intended to fall within the scope of the utility model. 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 utility model. 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 utility model 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 utility model will be understood in specific cases by those of ordinary skill in the art. The terminology used herein in the description of the utility model is for the purpose of describing particular embodiments only and is not intended to be limiting of the utility model.

It should be further noted that, in the description of the present utility model, 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 utility model 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 utility model. 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

An annuloplasty ring comprising an annular body and a protective layer wrapped around the annular body; the shape of the annular main body is saddle-shaped; wherein the annular main body is made of metal; the protective layer comprises an extension material layer 11 and a braided fabric layer 12, wherein the extension material layer 11 is coated on the periphery of the annular main body, the braided fabric layer 12 is coated on the periphery of the extension material layer 11, and one side of the braided fabric layer 12 is provided with a sewing part 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 protective layer can protect the annular main body on one hand, the structure is reliable, and on the other hand, abrasion to the heart valve is avoided; the annular main body is hollow and 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.

Further, 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 at least two 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 the adjacent first connecting pieces 5.

Specifically, the heart valve 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 heart valve 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 at least two first connecting pieces 5 which are sequentially connected, so that 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.

In this embodiment 1, the front ring section 1 and the rear ring section 2 each include a connection assembly movably connected to one end or/and both ends of the main body tube 4, the connection assembly includes at least one second connection member 6, one end of the second connection member 6 is movably connected to the main body tube 4, and the other end of the second connection member 6 is connected to the adjacent first connection member 5; one end of the first connecting piece 5 is provided with a first limit connecting block 7, the other end of the first connecting piece 5 is provided with a first limit connecting groove 8, the first limit connecting block 7 is rotatably arranged in the first limit connecting groove 8, a first movable gap is arranged between the first limit connecting block 7 and the first limit connecting groove 8, and the adaptive expansion and contraction of the transition ring section 3 are realized through the first movable gap; 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; 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.

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. 9 to 10, the first connector 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 a rear end of the main connecting portion 14, two positioning arms 18 opposite to each other are disposed at a front end of the secondary connecting portion 15, the main connecting portion 14 and the secondary connecting portion 15 are both in a hollow state, the positioning structure portion 16 is inserted into the secondary connecting portion 15 and the 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, so that the positioning effect between the positioning arm 18 and the positioning cavity 17 is ensured, 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 described above, which is not repeated here.

The present utility model 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 utility model.

Claims

1. An annuloplasty ring, characterized by: comprises an annular main body and a protective layer coated on the periphery of the annular main body;

2. An annuloplasty ring according to claim 1, wherein: the front ring section and the rear ring section respectively comprise a connecting component movably connected to one end or/and two ends of the main body pipe, the connecting component comprises 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.

3. An annuloplasty ring according to claim 1, wherein: one end of the first connecting piece is provided with a first limiting connecting block, the other end of the first connecting piece is provided with a first limiting connecting groove, and the first limiting connecting block is rotationally arranged in the first limiting connecting groove.

4. An annuloplasty ring according to claim 2, wherein: 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.

5. An annuloplasty ring according to claim 1, wherein: the annular main body is made of metal; the protective layer comprises an extension material layer and a braided fabric layer, wherein the extension material layer is coated on the periphery of the annular main body, the braided fabric layer is coated on the periphery of the extension material layer, and one side of the braided fabric layer is provided with a sewing position.

6. An annuloplasty ring according to claim 5, wherein: 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.

7. An annuloplasty ring according to claim 1, wherein: the annular main body is hollow and tubular.

8. An annuloplasty ring according to claim 1, wherein: the first connecting piece comprises a main connecting part, an auxiliary connecting part and a positioning structure part, wherein a positioning cavity is formed in the rear end of the main connecting part, two positioning arms which are just opposite to each other are arranged at the front end of the auxiliary connecting part, the main connecting part and the auxiliary connecting part are in hollow states, the positioning structure part is inserted into the auxiliary connecting part and the main connecting part, the positioning structure part is positioned between the two positioning arms, and the positioning structure part is used for pushing up the two positioning arms so that the positioning arms are clamped in the positioning cavity.