阅读说明：本技术 一种人工心脏瓣膜 (Artificial heart valve ) 是由 蔡涛 张旭 吕向东 于 2021-09-07 设计创作，主要内容包括：本发明公开一种人工心脏瓣膜,包括环形瓣架、环形标识架、标识件和瓣叶,其中：所述环形瓣架和所述环形标识架的轴线重合,且所述环形瓣架的沿轴向的一端和所述环形标识架的沿轴向的一端连接固定；所述环形标识架的远离所述环形瓣架的一端与所述标识件连接,所述环形瓣架的平行于轴线的侧面设有锚定梁,所述标识件和所述锚定梁沿着平行于轴线的方向设置；所述瓣叶位于所述环形瓣架的环内,且所述瓣叶通过所述锚定梁和所述环形瓣架连接固定。本发明通过在环形标识架上设置一具有标识能力的标识件,能够使术者在手术过程中确认人工心脏瓣膜的环向位置,解决了现有技术中人工心脏瓣膜无法进行环向定位的问题。(The invention discloses a heart valve prosthesis, which comprises an annular valve frame, an annular identification frame, an identification component and valve blades, wherein: the axes of the annular valve frame and the annular identification frame are overlapped, and one axial end of the annular valve frame and one axial end of the annular identification frame are fixedly connected; one end, far away from the annular valve frame, of the annular identification frame is connected with the identification piece, the side face, parallel to the axis, of the annular valve frame is provided with an anchoring beam, and the identification piece and the anchoring beam are arranged along the direction parallel to the axis; the valve leaf is positioned in the ring of the annular valve frame, and the valve leaf is fixedly connected with the annular valve frame through the anchoring beam. According to the invention, the annular identification frame is provided with the identification piece with identification capability, so that an operator can confirm the annular position of the artificial heart valve in the operation process, and the problem that the artificial heart valve cannot be positioned in the annular direction in the prior art is solved.)

1. A heart valve prosthesis comprising an annular valve frame, an annular marker frame, a marker, and leaflets, wherein:

the axes of the annular valve frame and the annular identification frame are overlapped, and one axial end of the annular valve frame and one axial end of the annular identification frame are fixedly connected;

one end, far away from the annular valve frame, of the annular identification frame is connected with the identification piece, the side face, parallel to the axis, of the annular valve frame is provided with an anchoring beam, and the identification piece and the anchoring beam are arranged along the direction parallel to the axis;

the valve leaf is positioned in the ring of the annular valve frame, and the valve leaf is fixedly connected with the annular valve frame through the anchoring beam.

2. The prosthetic heart valve of claim 1, wherein an end of the annular marker housing distal from the annular valve housing is provided with a securing ring having an axis directed toward a center of the annular marker housing, the securing ring corresponding with the anchoring beam in a direction of the annular valve housing axis;

the identification piece is provided with a circular bulge, and the identification piece and the annular identification frame are fixedly connected through the circular bulge and the fixing ring.

3. The prosthetic heart valve of claim 2, wherein the circular protrusion has a shape and size that is compatible with a shape and size of the fixation ring.

4. The prosthetic heart valve of claim 2, wherein a plurality of the anchoring beams are uniformly disposed on a side of the annular valve frame parallel to the axis.

5. The prosthetic heart valve of claim 4, wherein the number of the securing rings is the same as the number of the anchoring beams, and the securing rings are evenly distributed on a side of the annular marker frame away from the annular valve frame;

the number of the identification pieces is consistent with that of the fixing rings.

6. The prosthetic heart valve of claim 2, wherein the annular marker support is wave-shaped, the retaining ring is located at a peak of the annular marker support, and the annular valve support and a valley of the annular marker support are fixedly connected.

7. The prosthetic heart valve of claim 1, wherein the annular valve frame is a mesh structure.

8. The prosthetic heart valve of claim 7, wherein the direction of the anchoring beam coincides with the axial direction of the annular valve frame.

9. The prosthetic heart valve of claim 1, wherein the material of the annular valve frame and the annular marker frame is a shape memory material.

10. The prosthetic heart valve of claim 1, wherein the marker is a platinum iridium alloy material.

Technical Field

The invention relates to the technical field of medical instruments, in particular to a prosthetic heart valve.

Background

The incidence of prosthetic heart valve disease increases with the life of the individual, becoming a common type of heart disease. The current treatment of prosthetic heart valve disease is usually the implantation of a prosthetic heart valve as a means of replacing the native heart valve. However, the current artificial heart valve can only fix the axial position, and the circumferential position of the artificial heart valve is not positioned, so that the risk of interference with a coronary opening after implantation of the artificial heart valve is high.

Therefore, the problem that the circumferential position of the artificial heart valve cannot be positioned exists in the prior art.

Disclosure of Invention

The embodiment of the invention provides a prosthetic heart valve, which aims to solve the problem that the circumferential position of the prosthetic heart valve cannot be positioned in the prior art.

In order to achieve the above object, an embodiment of the present invention provides a prosthetic heart valve, including an annular valve frame, an annular identification frame, and an identification member, wherein:

the axes of the annular valve frame and the annular identification frame are overlapped, and one axial end of the annular valve frame and one axial end of the annular identification frame are fixedly connected;

one end, far away from the annular valve frame, of the annular identification frame is connected with the identification piece, the side face, parallel to the axis, of the annular valve frame is provided with an anchoring beam, and the identification piece and the anchoring beam are arranged along the direction parallel to the axis;

the valve leaf is positioned in the ring of the annular valve frame, and the valve leaf is fixedly connected with the annular valve frame through the anchoring beam.

As an alternative embodiment, one end of the annular identification frame far away from the annular valve frame is provided with a fixing ring, the axis of the fixing ring faces to the center of the annular identification frame, and the fixing ring corresponds to the anchoring beam in the direction of the axis of the annular valve frame;

the identification piece is provided with a circular bulge, and the identification piece and the annular identification frame are fixedly connected through the circular bulge and the fixing ring.

As an alternative embodiment, the shape and size of the circular projection are adapted to the shape and size of the fixing ring.

As an alternative embodiment, the side surface of the annular valve frame parallel to the axis is uniformly provided with a plurality of the anchoring beams.

As an alternative embodiment, the number of the fixing rings is the same as that of the anchoring beams, and the fixing rings are uniformly distributed on one side of the annular identification frame far away from the annular petal frame;

the number of the identification pieces is consistent with that of the fixing rings.

As an optional implementation manner, the annular identification frame is in a wave shape, the fixing ring is located at a wave crest of the annular identification frame, and the annular flap frame and the wave trough of the annular identification frame are fixedly connected.

As an alternative embodiment, the annular valve frame is a net structure.

As an alternative embodiment, the direction of the anchoring beam coincides with the axial direction of the annular valve frame.

As an alternative embodiment, the material of the annular valve frame and the annular identification frame is a shape memory material.

In an alternative embodiment, the material of the marker is platinum-iridium alloy material.

In the embodiment of the invention, the annular identification frame is provided with the plurality of identification pieces corresponding to the anchoring beams, and the identification pieces can be accurately positioned through the device, so that an operator can confirm the annular position of the annular valve frame in the implantation process, and the problem that the annular position of the artificial heart valve cannot be positioned in the prior art is solved.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the description of the embodiments of the present invention will be briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art that other drawings can be obtained according to these drawings without inventive exercise.

FIG. 1 is a schematic diagram of a prosthetic heart valve according to an embodiment of the present invention;

FIG. 2 is a top view of a prosthetic heart valve provided in accordance with an embodiment of the present invention;

FIG. 3 is a schematic illustration of a deployment surface of a valve frame of a prosthetic heart valve according to an embodiment of the present invention;

FIG. 4 is a schematic structural diagram of a tag provided in an embodiment of the present invention;

FIG. 5 is another view of a tag provided by an embodiment of the present invention;

FIG. 6 is a schematic view of the mounting position of the identification member provided by the embodiment of the present invention;

FIG. 7 is a schematic illustration of a prosthetic heart valve according to an embodiment of the present invention in a position mounted on a delivery device;

FIG. 8 is a schematic illustration of a prosthetic heart valve implantation procedure provided by an embodiment of the present invention;

FIG. 9 is a schematic cross-sectional view of a prosthetic heart valve implantation site provided by an embodiment of the present invention;

FIG. 10 is a schematic plan view of a prosthetic heart valve implantation site provided by an embodiment of the present invention.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are some, but not all embodiments of the present application. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.

The terms first, second and the like in the description and in the claims of the present application are used for distinguishing between similar elements and not necessarily for describing a particular sequential or chronological order. It should be understood that the data so used are interchangeable under appropriate circumstances such that embodiments of the application can be practiced in sequences other than those illustrated or described herein, and the terms "first" and "second" used herein generally do not denote any order, nor do they denote any order, for example, the first object may be one or more.

As shown in fig. 1, 2 and 3, an embodiment of the present invention provides a prosthetic heart valve including an annular valve frame 10, an annular marker frame 20, a marker 30 and a leaflet 40, wherein:

the axial lines of the annular valve frame 10 and the annular identification frame 20 are overlapped, and one axial end of the annular valve frame 10 and one axial end of the annular identification frame 20 are fixedly connected;

one end of the annular identification frame 20 far away from the annular valve frame 10 is connected with the identification piece 30, the side surface of the annular valve frame 10 parallel to the axis is provided with an anchoring beam 101, and the identification piece 30 and the anchoring beam 101 are arranged along the direction parallel to the axis;

the leaflet 40 is located within the annulus of the annular frame and the leaflet 40 is secured in connection with the annular frame by the anchoring beam.

In this embodiment, to realize the circumferential positioning of the artificial heart valve, the annular identification frame 20 is provided with the identification member 30. The circumferential positioning of the artificial heart valve is realized by arranging the identifier 30 so that an operator can confirm the circumferential position of the artificial heart valve according to the identifier 30 when implanting the artificial heart valve.

Wherein, the anchoring beam 101 and the valve leaflet 40 of the artificial heart valve are fixed by sewing, so that when the artificial heart valve is positioned in the circumferential direction in the implantation process, the position of the anchoring beam 101 is arranged at the junction of the native valve leaflets, thereby realizing the superposition of the artificial heart valve and the native heart valve and reducing the risk of interference with coronary opening.

In order to enable the anchoring beam 101 to be positioned correctly, the radiopaque marker 30 is arranged in the direction parallel to the axis of the anchoring beam 101, so that the circumferential position of the marker 30 is consistent with the circumferential position of the anchoring beam 101, and an operator can confirm the circumferential position of the artificial heart valve only by confirming the position of the marker 30 under X rays in the process of implanting the artificial heart valve.

As an alternative embodiment, as shown in fig. 3, 4 and 5, one end of the annular identification frame 20 far away from the annular valve frame 10 is provided with a fixing ring 201, the axis of the fixing ring 201 faces the center of the annular identification frame 20, and the fixing ring 201 corresponds to the anchoring beam 101 in the direction of the axis of the annular valve frame 10;

the identification member 30 is provided with a circular protrusion, and the identification member 30 and the annular identification frame 20 are connected and fixed through the circular protrusion and the fixing ring 201.

In this embodiment, the identifier 30 and the annular identifier 20 need to be processed separately, and after the processing, the identifier 30 and the fixing ring 201 are connected and fixed by laser welding to fix the identifier 30 and the annular identifier 20, so that an operator can perform annular positioning.

Wherein the marker 30 is fixed on the fixing ring 201 of the annular marker housing 20, the fixing ring 201 and the marker 30 being located in a direction parallel to the anchoring beam 101 for achieving the annular positioning, as shown in fig. 6. However, since the marker 30 has a certain thickness, in order to reduce the interference risk of the marker 30, the position of the fixing ring 201 is recessed toward the axis of the annular marker holder 20, so that the marker 30 does not exceed the edge of the annular valve holder 10, thereby preventing the artificial heart valve from being scratched after being implanted.

As an alternative embodiment, the shape and size of the circular projection are adapted to the shape and size of the fixing ring 201.

In this embodiment, since the identification member 30 and the fixing ring 201 are two components processed respectively, and the identification member 30 needs to realize the circumferential positioning at the position of the fixing ring 201, the shape and size of the identification member 30 and the fixing ring 201 need to be adapted to realize the connection and fixation.

In the embodiment of the present invention, the protrusion of the marker 30 is set to be circular, so that the marker can be more conveniently mounted and connected with the fixing ring 201. The marker 30 may be shaped as shown in fig. 4 and 5 to confirm the position of the annular valve holder 10 by observing the marker position.

As an alternative embodiment, as shown in fig. 2, the side of the annular valve frame 10 parallel to the axis is uniformly provided with a plurality of anchoring beams 101.

In the present embodiment, the anchoring beams 101 are positions to be joined to the leaflets 40 of the artificial heart valve, and in the present embodiment, the artificial heart valve may be a three-leaflet valve, so that the number of the anchoring beams 101 is three.

As an alternative embodiment, the number of the fixing rings 201 is the same as that of the anchoring beams 101, and the fixing rings 201 are uniformly distributed on the side of the annular sign frame 20 away from the annular petal frame 10;

the number of identification members 30 corresponds to the number of fixing rings 201.

In the present embodiment, too, in order to adapt to a plurality of anchor beams 101, the number of the markers 30 and the fixing rings 201 needs to be adjusted accordingly to achieve the correspondence of the number of the anchor beams 101 and the fixing rings 201, and the number of the fixing rings 201 and the markers 30.

Wherein, owing to set up a plurality of fixed rings 201 and a plurality of identification member 30, can establish fixed ring 201 and identification member 30 in the plane of same perpendicular to axis, at the in-process of implanting prosthetic heart valve, the operator can confirm prosthetic heart valve's hoop position through observing identification member 30, and can also confirm prosthetic heart valve's axial position through the plane that identification member 30 belongs to the precision of prosthetic heart valve implantation has been improved.

As an alternative embodiment, the annular sign frame 20 is in a wave shape, the fixing ring 201 is located at the wave crest of the annular sign frame 20, and the annular flap frame 10 is connected and fixed with the wave trough of the annular sign frame 20.

In this embodiment, since the prosthetic heart valve needs to be compressed and then released during the implantation process, the annular marker 20 is set to have a waveform, so that the annular marker 20 can be compressed at a radial position while maintaining a certain strength at an axial position.

Wherein the radial direction of the annular marker housing 20 is compressed during the compression process, in order to reduce the change of the position of the marker 30 during the compression and release processes, as shown in fig. 3 and 6, the marker 30 and the fixing ring 201 are disposed along the axial direction parallel to the annular marker housing 20, thereby reducing the influence of the compression and release processes on the position of the marker 30 during the implantation process.

As an alternative embodiment, the annular valve frame 10 is a net structure.

In this embodiment, too, the prosthetic heart valve needs to be compressed and then released during implantation, and the annular valve frame 10 is provided as a mesh structure in order to achieve this process, thereby enabling the radial direction to be compressed while maintaining axial strength.

The net structure of the annular valve frame 10 may be a diamond structure or a hexagon structure.

As an alternative embodiment, the direction of the anchoring beam 101 coincides with the axial direction of the annular petal holder 10.

In this embodiment, the prosthetic heart valve is compressed during implantation, and the anchoring beam 101 is a position connected to the leaflet 40, and needs to maintain structural stability, so the anchoring beam 101 is disposed along a direction parallel to the axis, so that the anchoring beam 101 can maintain a shape after being compressed.

As an alternative embodiment, the material of the annular valve frame 10 and the annular marker frame 20 is a shape memory material.

In the present embodiment, the annular valve frame 10 and the annular marker frame 20 need to be restored to the pre-compression state after being compressed, and a material with shape memory property, such as a nickel-titanium alloy material, is used to enable the artificial heart valve to be restored to the pre-compression state after being compressed.

In an alternative embodiment, the marker 30 is made of a platinum-iridium alloy.

In the present embodiment, the marker 30 made of platinum-iridium alloy material is used, so that an operator can observe the marker 30 during the implantation of the artificial heart valve, and the circumferential position of the artificial heart valve is confirmed by the marker 30.

As shown in fig. 7, the prosthetic heart valve is fixed on the delivery device and is implanted in the body under the operation of the operator, as shown in fig. 8, the prosthetic heart valve is compressed during the delivery process, and the operator can judge the position condition of the prosthetic heart valve after being released according to the identification piece 30 during the delivery process. After the target position of conveying, the artificial heart valve is expanded and restored to the state before compression, and the artificial heart valve is abutted and fixed with the inner wall of the blood vessel, so that the implantation process is completed.

As shown in fig. 9, the native heart valve is a tri-leaflet valve, and after the artificial heart valve is implanted, the positions of the leaflets 40 are consistent with the positions of the leaflets of the native heart valve, so as to reduce the risk of coronary interference.

Also, the installed position can be revealed by a plane, as shown in fig. 10, and the position of the native leaflets is shown in a plan view, and the anchoring beam 101, the fixing ring 201, and the marker 30 are located on the same straight line parallel to the axial direction after the implantation of the prosthetic heart valve, and the straight line is located at the boundary between the native leaflets, so that the prosthetic heart valve after the implantation can be maintained in correspondence with the leaflet positions of the native heart valve.

It should be noted that, in this document, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising an … …" does not exclude the presence of other like elements in a process, method, article, or apparatus that comprises the element.

While the present invention has been described with reference to the embodiments shown in the drawings, the present invention is not limited to the embodiments, which are illustrative and not restrictive, and it will be apparent to those skilled in the art that various changes and modifications can be made therein without departing from the spirit and scope of the invention as defined in the appended claims.