CN120585517A - Artificial heart valve and processing method thereof - Google Patents

Abstract

The present application discloses an artificial heart valve and a processing method. The artificial heart valve includes a stent and a plurality of leaflets connected to the stent. The stent is a cylindrical structure with a blood flow channel inside. The leaflets include: a body, which has relative transverse and longitudinal directions in a flattened state. The outer edge of the body includes a free edge and a fixed edge distributed on two opposite sides of the longitudinal direction. The plurality of leaflets are fixed to the stent by their respective fixed edges. The free edges of the plurality of leaflets cooperate with each other to control the blood flow channel in the artificial heart valve; an ear piece, which is arranged on two opposite sides of the body in the transverse direction. The free edge and the fixed edge intersect at the ear piece on the corresponding side. The ear piece has: a first bending portion, which is bent from the joint between the ear piece and the body to the transverse inner side of the body and abuts against the body to form a double-layer structure joint; a second bending portion, which is bent from the end of the first bending portion to the transverse outer side of the body. The present application improves the sealing effect and safety of the leaflet by improving the leaflet structure and suturing method.

Description

Artificial heart valve and processing method thereof

Technical Field

The application relates to the technical field of medical appliances, in particular to a heart valve prosthesis and a processing method.

Background

The existing artificial heart valve comprises a bracket and valve blades arranged on the bracket, wherein the bracket is cylindrical and is internally provided with a blood flow channel, the valve blades comprise free edges, fixed edges and lugs which are intersected with the free edges, the free edges control the blood flow channel in the artificial heart valve through deformation, and the fixed edges are used for being fixed with the bracket.

The artificial heart valve can be applied to the aortic valve, the mitral valve, the tricuspid valve and the like, two or three corresponding valve blades are selected according to different adaptability of application scenes, and three valve blades are taken as an example and can be connected to the bracket in a suture, bonding or integrated forming mode.

Referring to fig. 1-3, the top side of the leaflet 100 in the prosthetic heart valve 200 is a free edge 120, the bottom side is a fixed edge 130, the intersection of the free edge 120 and the fixed edge 130 is an ear 140, during processing, the ear 140 of two adjacent leaflets is firstly stitched by a suture and then integrally connected to the bracket 210, but the suture after tightening during stitching can deform the free edge to a certain extent, so that the close to the bracket part may cause poor closure, and the sealing effect of the blood flow channel is affected.

Disclosure of Invention

The application provides a valve leaflet of a prosthetic heart valve, the prosthetic heart valve and a processing method, and solves the problem of poor closure of the valve leaflet in the prior art.

The present application provides a leaflet of a prosthetic heart valve, comprising:

the body is provided with opposite transverse directions and longitudinal directions in a flattened state, and the outer edge of the body comprises free edges and fixed edges which are distributed on two opposite sides of the longitudinal direction;

The lug is arranged on two transverse opposite sides of the body, the free edge and the fixed edge are intersected on lugs on the corresponding sides, an outer lug part extending longitudinally relative to the free edge is arranged at the joint of the lug and the free edge, and the outer lug part is intersected with a trend extension line of the fixed edge.

The following provides several alternatives, but not as additional limitations to the above-described overall scheme, and only further additions or preferences, each of which may be individually combined for the above-described overall scheme, or may be combined among multiple alternatives, without technical or logical contradictions.

Optionally, at least 1/4 of the outer flange area is inboard of the extension of the fixed rim.

Optionally, the outer protruding portion is strip-shaped, and the length direction of the strip-shaped portion is transversely consistent with the body.

Optionally, the outer flange has opposite inner and outer edges along a lateral direction of the body, the outer edge being in a turning transition with the top side of the tab.

Optionally, the outer edge is substantially parallel to the outer side edge of the tab.

Optionally, the outer side edge of the tab extends at least 2mm beyond the outer edge in a lateral direction of the body.

Optionally, along the transverse direction of the body, the outer side edge of the lug exceeds the outer edge by 2.5-5 mm.

Optionally, the part of the lug plate combined with the fixing edge is provided with an opening area.

Optionally, the lateral positions of both the outer flange and the open area are aligned.

Optionally, the lateral length of the outer protruding portion is 1-3 mm, and the longitudinal length is 0.2 mm-0.8 mm. For example, the lateral length of the outer protruding portion is 1.08-2.43 mm, and the longitudinal length is 0.29-0.44 mm.

The embodiment of the application also discloses a prosthetic heart valve, which comprises a bracket and a plurality of valve leaflets connected with the bracket, wherein the bracket is of a cylindrical structure and is internally provided with a blood flow channel, and the valve leaflets comprise:

The body is provided with opposite transverse directions and longitudinal directions in a flattened state, the outer edge of the body comprises free edges and fixed edges which are distributed on two opposite sides in the longitudinal direction, the plurality of valve leaflets are fixed with the bracket through the respective fixed edges, and the free edges of the plurality of valve leaflets are matched with each other to control a blood flow channel in the artificial heart valve;

A tab disposed on opposite lateral sides of the body, the free edge and the fixed edge meeting at a tab on a respective side, the tab having:

the first bending part bends from the joint part of the lug and the body to the inner lateral side of the body and is mutually abutted with the body to form a joint part with a double-layer structure;

a second bending part which bends from the tail end of the first bending part to the outer lateral side of the body;

The combination parts between two adjacent valve blades are mutually stuck and sewed and fixed, and are propped and fixed on the radial inner side of the bracket, the second bending parts of the valve blades extend to the radial outer side of the bracket and wrap the corresponding parts of the bracket, and the second bending parts are sewed and fixed with the bracket at the wrapping parts.

Optionally, an outer part extending longitudinally relative to the free edge is arranged at a position where the lug and the free edge are combined, and in the combination part, the outer part is folded in half.

Optionally, the joint between two adjacent leaflets is secured by a first suture, the first suture being one or more, all knots in the first suture being on the top side of the outer flange. The first suture is preferably one.

Preferably, the first suture has two knots arranged side by side on the top side of the outer flange of adjacent leaflets.

Optionally, a plurality of wire holes are arranged along the longitudinal direction of the body, the first suture passes through each wire hole, and for at least one wire hole, the suture extends to the lateral outer side of the body through the wire hole and winds and wraps the bonding part.

Optionally, for all wire holes in the joint, the first suture extends laterally outward of the body via the wire holes and wraps around the joint.

Optionally, the junction is connected to the stent by a second suture.

Optionally, at least a portion of the support is a support bar, the second suture is encircling the support bar, and a plurality of channels are encircling along the extension direction of the support bar.

Optionally, all knots in the second suture are laterally of the support bar along the circumference of the stent.

Optionally, at least one side of the support bar is provided with a concave area along the circumferential direction of the bracket, and the knot in the second suture is positioned in the concave area.

Optionally, the second suture is provided with one knot each around one track.

Optionally, each of the second sutures extends through the juncture of adjacent leaflets radially inward of the stent.

Optionally, the second bending parts of the two adjacent valve leaflets wrap the support bar from two opposite sides of the support bar.

Optionally, the second fold wraps the knot of the second suture.

Optionally, the second bending part is connected to the supporting bar through a third suture, and all knots in the third suture are located at the lateral side of the supporting bar along the circumferential direction of the bracket. Preferably on the same side.

Optionally, the support bar has two opposite sides along the circumference of the support, wherein one side is provided with a first concave area for placing the thread of the second suture, and the other side is provided with a second concave area for placing the thread of the third suture.

Optionally, all knots in the second suture and the third suture are placed in corresponding recessed areas.

Optionally, the concave areas on the same side of the supporting bar are distributed along the extending direction of the supporting bar, the second suture lines and the third suture lines respectively encircle the supporting bar in multiple ways, each encircling line is provided with a line knot, and each line knot is positioned in the concave area with the corresponding position.

Optionally, each of the third sutures penetrates a junction of two adjacent leaflets and a second bend radially inward of the stent.

Optionally, in the same leaflet, the second bending portion and the bonding portion are mutually abutted to form a three-layer structure, and the third suture line penetrates through the three-layer structure.

Optionally, each of the second suture and the third suture is one or more.

Optionally, the first suture, the second suture, and the third suture pass through the joint through the same or different suture holes.

Optionally, two or three of the first suture, the second suture and the third suture are the same suture.

The embodiment of the application also discloses a prosthetic heart valve, which comprises a bracket and a plurality of valve leaflets connected with the bracket, wherein the bracket is of a cylindrical structure and is internally provided with a blood flow channel;

At least one part of the support is a support bar, at least one side of the support bar is provided with a concave area along the circumferential direction of the support bar, the valve leaflet is fixed with the support bar through a suture, and all knots in the suture are positioned in the corresponding concave area.

Optionally, the leaflet includes:

The body is provided with opposite transverse directions and longitudinal directions in a flattened state, the outer edge of the body comprises free edges and fixed edges which are distributed on two opposite sides in the longitudinal direction, the plurality of valve leaflets are fixed with the bracket through the respective fixed edges, and the free edges of the plurality of valve leaflets are matched with each other to control a blood flow channel in the artificial heart valve;

Tabs arranged on opposite lateral sides of the body, the free edge and the fixed edge meeting the tabs on the respective sides;

The ear pieces between two adjacent valve leaflets are connected with each other through a first suture and are also connected with the supporting strips through a second suture and a third suture, wherein all the knots in the second suture and the third suture are positioned in corresponding concave areas.

Optionally, the part of the lug between two adjacent valve leaflets connected with each other through the first suture is abutted against the radial inner side of the support strip.

Optionally, the lugs between two adjacent valve blades are matched with each other to wrap the supporting strips.

Optionally, the knot in the second suture is wrapped by the ear panel and the knot in the third suture is exposed to the ear panel.

Alternatively, two axial sides of the bracket are opposite inflow side and outflow side, wherein a circle of hexagonal cells is circumferentially arranged on the outflow side, and the supporting strip is used as a shared edge between two adjacent cells.

Optionally, the extending direction of the supporting bar is the axial direction of the bracket.

The embodiment of the application also discloses a processing method of the artificial heart valve, which comprises the following steps:

bending the joint part of the lug and the body to the inner side of the body in the transverse direction, and mutually abutting the lug and the body to form a joint part with a double-layer structure, wherein the outer part is folded in half by itself in the joint part;

the method comprises the steps that under the state that the combined parts of two adjacent valve leaflets are in abutting registration with each other, the outer convex parts of the two valve leaflets are stitched by using a first suture line, and knotted and fixed on the top side of the outer convex parts after stitching;

Threading the suture lines for a plurality of times at the joint parts of two adjacent valve leaflets to carry out suture reinforcement;

sewing the joint of two adjacent leaflets to the radially inner side of the stent using a second suture;

the lugs of two adjacent valve blades are bent towards the transverse outer side of the body and extend to the radial outer side of the support to fold the corresponding parts of the support, and the folded parts are sewn and fixed with the support by a third suture.

The application further improves the sealing effect and the safety of the valve leaflet by improving the valve leaflet structure and the sewing method.

Drawings

FIG. 1 is a schematic view of a prior art leaflet in an expanded state;

FIG. 2 is a schematic view of the multi-leaflet of FIG. 1 after suturing;

FIG. 3 is a schematic illustration of a prior art prosthetic heart valve;

FIG. 4 is a schematic view of the structure of the leaflets of an embodiment prosthetic heart valve in a flattened state;

FIG. 5 is a schematic view of the structure of the protrusion and the opening in FIG. 4;

FIG. 6a is a schematic diagram of a prosthetic heart valve according to an embodiment of the present disclosure;

FIG. 6b is a schematic view of a tab having a first bending portion and a second bending portion;

FIG. 7 is a schematic view of a structure for suturing a joint using a first suture;

FIG. 8 is a schematic view of the structure of the two leaflet coaptation;

FIG. 9 is a schematic view of the structure of FIG. 7 with two joints being unfolded;

FIG. 10 is a schematic view of a first suture stitched from top to bottom when two joints are deployed;

FIG. 11 is a schematic view of the first suture of FIG. 10 from bottom to top;

FIG. 12a is a schematic view of a frame according to an embodiment of the present application;

FIG. 12b is an enlarged view of A in FIG. 12 a;

FIG. 12c is a schematic view of a structure in which two joints are sewn to a support bar using a plurality of second stitches;

FIG. 13 is a schematic view of a construction in which the tabs of the leaflets are gathered around the support band and sewn using a plurality of third stitches;

FIG. 14a is a schematic view of a structure for stitching two joints to a support bar using a single second stitch;

FIG. 14b is a schematic view of a construction in which a single third suture is used to gather and stitch the ear pieces of the leaflet around the support strip;

FIG. 15a is a schematic view of a prosthetic heart valve according to an embodiment of the present disclosure;

FIG. 15b is a schematic view of a prior art leaflet of the present application being sewn with support strips in accordance with an embodiment of the present application;

FIG. 16 is a flow chart of a method of processing a prosthetic heart valve in accordance with one embodiment of the present application;

FIGS. 17-24 are schematic views of two leaflet suturing to a stent;

fig. 25 is a schematic structural view of a prosthetic heart valve according to an embodiment of the present application.

Reference numerals in the drawings are described as follows:

100. Leaflet 110, body 120, free edge 130, fixed edge 131, open area 140, tab 150, outer flange 151, inner edge 152, outer edge 170, bond 171, first bend 172, second bend 173, wire hole 173b, wire hole 173c, wire hole 173d, wire hole 173e, wire hole 173f, wire hole 174, first suture 175, wire hole 175a, wire hole 175b, wire hole 175c, wire hole 176, second suture 177, wire hole 177a, wire hole 177b, wire hole 177c, wire hole 178, third suture 180, wire knot 181, wire knot 182, wire knot;

200. Prosthetic heart valves, 210, stents, 220, support struts, 221, recess regions, 222, first recess regions, 222a, first recess regions, 222b, first recess regions, 222c, first recess regions, 223, second recess regions, 223a, second recess regions, 223b, second recess regions, 223c, second recess regions;

300. The anti-leakage device comprises an anti-leakage component, 310, a substrate and 320, and an anti-leakage component.

Detailed Description

The following description of the embodiments of the present application 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 application, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.

It will be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. When an element is referred to as being "disposed on" another element, it can be directly on the other element or intervening elements 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 application belongs. The terminology used herein in the description of the application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The term "and/or" as used herein includes any and all combinations of one or more of the associated listed items.

In the present disclosure, the terms "first," "second," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or as implicitly indicating the number, order of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include one or more such feature. In the description of the present application, the meaning of "plurality" means at least two, for example, two, three, etc., unless specifically defined otherwise.

In the present disclosure, the terms "comprises" and "comprising," and any variations thereof, are intended to cover a non-exclusive inclusion, such that a system, article, or apparatus that comprises a list of elements is not necessarily limited to those elements expressly listed but may include other elements not expressly listed or inherent to such article or apparatus.

Referring to fig. 4-5, an embodiment of the present application provides a leaflet 100 of a prosthetic heart valve, comprising a body 110 having opposite lateral and longitudinal directions in a flattened state, an outer edge of the body 110 comprising a free edge 120 and a fixed edge 130 distributed on opposite sides of the longitudinal direction, wherein the free edge 120 controls a blood flow path within the prosthetic heart valve by deformation;

The tabs 140 are disposed on opposite lateral sides of the body 110, the free edge 120 and the fixed edge 130 meet the tabs 140 on the respective sides, and the portions where the tabs 140 join the free edge 120 are provided with outer protrusions 150 extending longitudinally with respect to the free edge 120.

The transverse direction and the longitudinal direction according to the present application can refer to the X direction and the Y direction in fig. 4, specifically, the X direction is the transverse direction and the Y direction is the longitudinal direction. The leaflet 100 is generally symmetrical in overall construction, with one side being described below and in part in the figures as an example and the other side being the same. The petals She Caizhi can be formed using conventional techniques, such as biological or synthetic materials, having a desired strength and biocompatibility.

During suturing, the lugs 140 of the two valve leaflets 100 are folded and attached to be sewn, and finally, tightening and knotting are carried out, wherein the knot is specifically arranged on the outer flange 150, the outer flange 150 deforms and absorbs stress when the suture is tightened and knotted, the influence on the free edge 120 is greatly reduced, namely, the tightening and knotting of the suture can not generate obvious interference on the free edge 120, and the problem that a blood flow channel is closed poorly due to poor closure caused by deformation of the free edge 120 when the valve leaflets 100 are sutured is solved. The outer flange 150 also increases the area of the connection seam providing additional strength assurance.

The outer protrusion 150 in this embodiment intersects the trend extension of the fixation rim 130, which trend extension is substantially inboard of the working area of the leaflet 100, where the outer protrusion 150 is located to allow for both the strength of the connection and the size of the leaflet 100 opening, e.g., at least 1/4 of the area of the outer protrusion 150 is inboard of the extension of the fixation rim 130 (see L in fig. 4). Also for example, at least 1/2, or even 3/4 of the area of the outer flange 150 is inboard of the extension of the fixed rim 130.

The outer flange 150 is strip-shaped, approximately rectangular, and the length direction of the strip is transversely consistent with that of the body, and after the strip is folded into a double-layer structure, the necessary transverse span can still be maintained, so that the suture operation and the deformation extruded by the suture knot can be conveniently absorbed.

The outer flange 150 has opposed inner and outer edges 151, 152, with a sharp corner between the outer edge 152 and the top side of the tab 140, and such that the outer edge 152 is generally parallel to the outer side of the tab 140.

The outer flange 150 may provide sufficient circumferential structural strength to the wire hole 173a, which will be described later, after being folded back upon itself. To reduce folding and sewing operations on the tab 140, the outer side edge of the tab 140 extends at least 2mm beyond the outer edge 152, such as 2.5 to 5mm beyond the outer edge, in the transverse direction of the body. The tab 140 is provided with an open area 131 at the location where the securing rim 130 joins, and since the tab 140 needs to be folded during seaming, the open area 131 reduces the traction and deformation of the body 110 and tab 140 during folding, especially the release of traction stress during longitudinal deflection.

Further, the lateral positions of both the outer flange 150 and the open area 131 are aligned. In the unfolded state, the outer flange 150 is substantially rectangular, the lateral length of the outer flange 150 is greater than the lateral length of the opening area 131, and the opening area 131 is located below the center line of the rectangle (L1 is the center line in the figure). The folded outer flange 150 itself forms a double layer structure, further improving strength.

In this embodiment, the lateral length of the outer flange 150 is 1 to 3mm, and the longitudinal length is 0.2mm to 0.8mm. For example, the outer flange 150 has a lateral length of 1.08mm to 2.43mm and a longitudinal length of 0.29mm to 0.44mm.

Referring to fig. 6 a-6 b, an embodiment of the present application further discloses a prosthetic heart valve 200, which includes a stent 210 and a plurality of leaflets 100 connected to the stent 210, wherein the stent 210 has a cylindrical structure, the interior of the stent is a blood flow channel, and the side walls of the stent have a hollow grid structure, and the shape or size of the grid structure is not strictly limited unless specifically stated. For implantation, surgical or catheter intervention may be used, and the stent 210 may be formed by cutting a tube or braiding a wire according to a release mode by selecting a corresponding material, such as nickel-titanium alloy with shape memory capable of self-expanding in vivo, or stainless steel with balloon expansion release, etc. during the catheter intervention.

The present embodiment is modified for folding and suturing of the leaflet 100, wherein the leaflet 100 comprises:

The body 110 has opposite transverse directions and longitudinal directions in a flattened state, the outer edge of the body 110 comprises free edges 120 and fixed edges 130 distributed on two opposite sides in the longitudinal direction, the plurality of valve leaflets 100 are fixed with the support 210 through the respective fixed edges 130, and the free edges 120 of the plurality of valve leaflets 100 are matched with each other to control a blood flow channel in the artificial heart valve;

tabs 140 disposed on opposite lateral sides of the body 110, the free edge 120 and the fixed edge 130 meeting the tabs 140 on the respective sides, the tabs 140 having:

the first bending part 171 bends from the joint between the tab 140 and the body 110 to the inner side of the body 110 in the lateral direction, and is abutted against the body 110 to form a joint 170 with a double-layer structure;

a second bending portion 172 which is bent from the end of the first bending portion 171 to the lateral outside of the body 110;

The inner side and the outer side are the inner side with respect to the body 110 on the side close to the center line of the body 110, and the outer side on the side far from the center line of the body 110. In order to facilitate suturing with the stent 210, the joint portions 170 between two adjacent leaflets 100 are mutually abutted against and fixed to the radially inner side of the stent 210 (the joint portions 170 and the stent 210 may also be stitched and fixed), and the second bending portions 172 of the leaflets 100 extend to the radially outer side of the stent 210 and close the corresponding portions of the stent 210, and are stitched and fixed to the stent 210 at the closing portions.

The prosthetic heart valve 200 of the present embodiment may utilize the leaflet 100 of each of the above embodiments, i.e., the portion where the tab 140 joins the free edge 120 is provided with the outer flange 150 extending longitudinally with respect to the free edge 120, and in the joining portion 170, the outer flange 150 is folded in half (approximately in half along its midline) to increase strength.

Referring to fig. 7-8, the joint 170 between two adjacent leaflets 100 is secured by a first suture 174, one or more first sutures 174, and all knots 180 in the first suture 174 are located on the top side of the outer flange 150, so that the outer flange 150 can absorb stress and deformation at the knotted site after deformation. Specifically, the first suture 174 is passed through the two bonding portions 170, where the needle-threading portion is seen to be located at the intersection between the outer flange 150 and the extension line of the free edge 120, and then the first knotting process is performed, so that the two bonding portions 170 are pre-fixed, so that the subsequent continuous suture fixation is facilitated.

In order to better fix the coupling portion 170 between the adjacent two leaflets 100, a plurality of thread holes 173 are arranged along the longitudinal direction of the body 110 at the coupling portion 170, and the first thread 174 is threaded around each thread hole 173. In the multi-layer structure, the aligned wire holes on each layer are regarded as the same wire hole when the number is calculated, the number of the wire holes 173 on the longitudinal direction is 3, the wire holes 173a, the wire holes 173b and the wire holes 173c are respectively arranged near the outer flange 150, the wire holes 173a are arranged near the outer flange 150, after the bonding parts 170 of two adjacent valve leaves 100 are overlapped, the first suture 174 downwards passes through all the wire holes 173 from the knotting part on each side in the thickness direction, and the penetrating and winding sequence can have various modes, so that the first suture 174 between any two wire holes 173 only passes once and is not repeated on the path in order to avoid redundancy.

After the first suture 174 passes through all the suture holes 173, it returns to the top side of the outer flange 150, and then a second knotting process is performed to fix the two joints 170, where it can be seen that the first suture 174 has two knots 180 integrally and is arranged side by side on the top side of two adjacent outer flanges 150. At this time, the knot 180 interferes only with the outer protrusion 150, that is, the outer protrusion 150 deforms to some extent, and the deformation of the outer protrusion 150 interferes with the free edge 120 less strongly, thereby reducing the influence on the free edge 120.

Referring to fig. 9, in order to better reinforce both the junctions 170 in the lateral direction, for at least one wire hole, a first suture 174 is extended to the lateral outside of the body 110 via the wire hole (specifically, the wire hole 173a or/and the wire hole 173 b) and wound around the packed junction 170. In the present embodiment, the first suture 174 extends to the lateral outside of the body 110 at both of the wire holes 173a, 173b and winds around the wrapping-up joint 170.

Regarding the specific threading manner of the first suture 174, for example, referring to fig. 10 to 11, a schematic diagram of the first suture 174 with a specific threading hole 173 is adopted, wherein a solid line is specifically shown as an outer line (which can be seen), and a dotted line is specifically shown as a line (which is hidden between the line holes and cannot be seen) threaded between two corresponding line holes 173. For ease of understanding, the right side is a line hole of another leaflet 100, which is respectively indicated as a line hole 173d, a line hole 173e, and a line hole 173f, wherein when the first suture 174 is threaded, the line hole 173d is mutually attached to the line hole 173a, the line hole 173e is mutually attached to the line hole 173b, and the line hole 173f is mutually attached to the line hole 173 c.

Taking the downward stitching as an example, after the two bonding portions 170 are pre-fixed by threading and knotting, the first suture 174 is threaded into the wire hole 173a, then threaded into the other corresponding wire hole 173d from the inside of the wire hole 173a, threaded into the wire hole 173d to the wire hole 173e, threaded into the wire hole 173e to the wire hole 173b, threaded into the wire hole 173b to the wire hole 173c, threaded into the wire hole 173c to the wire hole 173f, and then upwards stitched, i.e. the first suture 174 is threaded into the wire hole 173f to the wire hole 173e, threaded out of the wire hole 173b after circumferentially winding the suture around the wire hole 173e and the wire hole 173b until threaded into the wire hole 173a, and similarly threaded out of the wire hole 173d after circumferentially winding the suture around the wire hole 173a and the wire hole 173d and knotted and fixed with the other end of the suture again, so as to complete the threading of the first suture 174. Of course, other manners of threading may be adopted, and the embodiment does not require any special requirement. Preferably the same path is not repeated.

Referring to fig. 12 a-13, after the first suture 174 is threaded, the joint 170 is connected to the inner side of the stent 210 by the second suture 176. The bracket 210 generally has a hollowed-out grid structure, and the fixing edge 130 can be fixed by stitching according to the prior art, and the application also improves the connection mode between the lug 140 and the bracket 210.

At least a portion of the support frame 210 in the embodiment of the present application is a support bar 220, and the support bar 220 may be a portion of the grid frame (of course, the support bar 220 may also be located on the top side of the support frame 210, and the specific position may be set according to the requirement), so that, in order to adapt to the fixing of the ear piece 140, the overall extending direction of the support bar 220 is the axial direction of the support frame 210, but the support bar 220 is not strictly limited to be a straight bar.

The second suture 176 is wound around the joint 170 and around the outside of the supporting strip 220, and is wound along the extending direction of the supporting strip 220. Corresponding wire holes 175 for threading the second suture 176 are arranged in the longitudinal direction.

The wire holes 175 of the second suture 176 are closer to the support bar 220 than the wire holes 173 penetrating the first suture 174, and can be arranged in a longitudinal dislocation manner with the wire holes 173, so that strength loss caused by too close adjacent wire holes is avoided.

In this embodiment, the wire holes 175 are axially arranged, and the number of the wire holes is specifically 3, and the 3 wire holes are located on the joint 170, namely, the wire hole 175a, the wire hole 175b and the wire hole 175c. Of course, the number of the wire holes 175 is not particularly limited, and may be set as required.

Further, all knots 181 in second suture 176 are laterally of support bar 220 along the circumference of stent 210, avoiding increased radial dimensions after compression, reducing friction against external tissue or components. Preferably, all knots 181 in second suture 176 are on the same side of support bar 220.

To facilitate fixation of knot 181, at least one side of support bar 220 is provided with a recessed area 221 along the circumference of support bar 210, knot 181 in second suture 176 is located in recessed area 221, recessed area 221 may be a structural bend of support bar 220 itself, a cut-out portion, or a branched structure such as a grid, recessed area 221 facilitates fixation of knot 181 to reduce a protruding portion, and knot 181 is not easily slid axially out in recessed area 221.

With respect to the strength of the connection between reinforcement matrix 170 and support bar 220, second stitches 176 each have a knot 181 encircling them. Wherein, each of the second sutures 176 penetrates the bonding portion 170 of two adjacent leaflets 100 radially inward of the stent 210, so that the bonding portions 170 are more tightly bonded, and each knot 181 is placed in the corresponding recessed region 221.

The second bending parts 172 of the adjacent two leaflets 100 wrap the support bars 220 from the opposite sides of the support bars 220 to improve the connection strength, and the second bending parts 172 wrap the knot 181 of the second suture 176, so that the whole is more concise, and the exposed knot number is reduced. Second fold 172 is connected to support bar 220 by third suture 178, and all knots 182 in third suture 178 are located laterally of support bar 220 along the circumference of stent 210. Of course, to facilitate tying and positioning, all knots 182 of third suture 178 are preferably on the same side of support bar 220. I.e., for the same support bar 220, all knots 181 of the second suture 176 are placed in a first recessed area 222 on one side and all knots 182 of the third suture 178 are placed in a second recessed area 223 on the other side, along the circumferentially opposite sides of the stent 210.

All knots 180 in the second suture 176 and the third suture 178 are placed in corresponding recessed areas. First recessed area 222 and second recessed area 223 may be symmetrically or offset with respect to support bar 220.

The concave areas on the same side of the support bar 220 are arranged in a plurality along the extending direction of the support bar 220, the second suture 176 and the third suture 178 respectively encircle the support bar 220 in a plurality of ways, each encircling way is provided with a knot, and each knot is positioned in the corresponding concave area.

Each of the third sutures 178 penetrates the joint 170 and the second bending portion 172 of the adjacent two leaflets 100 at the radially inner side of the stent 210, that is, in the same leaflet 100, the second bending portion 172 and the joint 170 are abutted against each other to form a three-layer structure, and the third suture 178 penetrates the three-layer structure. Of course, when the third suture 178 penetrates the joint 170, the third suture 178 may be threaded through the thread hole 175 of the second suture 176 in consideration of the problem of reducing the number of thread holes as much as possible.

In this embodiment, one second suture 176 and one third suture 178 are preferred, and referring to fig. 14a to 14b, a schematic suture diagram of the case where the second suture 176 is one and a schematic suture diagram of the case where the third suture 178 is one are shown, and the sutures between two adjacent sutures extend continuously. Of course, the specific way of knotting is not unique and can be done in a variety of existing ways.

The first suture 174, the second suture 176, and the third suture 178 pass through the junction 170 through the same or different suture holes. For example, the thread hole 173 of the first thread 174 and the thread hole 175 of the second thread 176 may be partially or even entirely overlapped and shared.

Two or three of the first suture 174, the second suture 176, and the third suture 178 are the same suture. I.e. after each stage of suturing, the suture is not cut off, but directly enters the next stage of suturing. Each of second suture 176 and third suture 178 is not strictly limited to only one turn, and support bar 220 may be placed one or more turns.

The support bar 220 with the concave area 221 can accommodate the knot, avoid the knot being positioned outside the support 210, and can be combined with the valve leaflet of the existing structure, for example, referring to fig. 15 a-15 b, an embodiment of the application also discloses a prosthetic heart valve 200, wherein the prosthetic heart valve 200 comprises a support 210 and a plurality of valve leaflets 100 connected with the support 210, the support 210 is of a cylindrical structure and the interior is a blood flow channel;

The stent 210 may be a balloon expandable stent or a self-expanding stent, and the material of the stent 210 may be cobalt-chromium alloy or nitinol.

The stent 210 is tubular in configuration, is generally straight cylindrical, or has a slightly flared inflow end. The support 210 has hollow cells, two ends of the support 210 are an inflow side and an outflow side, the support can have a plurality of rows of cells from the inflow end to the outflow end, and the cells can be quadrilateral and hexagonal. For example, as shown in fig. 25, the outflow end may be a row of hexagonal cells, and the rest may be quadrangular cells.

In the row of cells at the outflow end of the stent 210, each hexagonal cell comprises axially vertical struts, at least some of which are struts 220 (see fig. 12 a) for fixing the leaflets, for example comprising 3 struts, and the 3 struts are uniformly distributed in the circumferential direction.

Along the circumference of the stent, at least one side of support band 220 is provided with a recessed area 221 (see fig. 12 b), and leaflet 100 is secured to support band 220 by a suture, with all knots in the suture located in the corresponding recessed area 221, making the whole more compact and reducing interference with the remaining components.

Wherein the leaflet 100 comprises:

The body 110 has opposite transverse and longitudinal directions in a flattened state, and the outer edge of the body comprises free edges 120 and fixed edges 130 distributed on two opposite sides in the longitudinal direction, the plurality of valve leaflets 100 are fixed with the support 210 through the respective fixed edges 130, and the free edges of the plurality of valve leaflets 100 are matched with each other to control a blood flow channel in the artificial heart valve;

Tabs 140 disposed on opposite lateral sides of the body, the free edge 120 and the fixed edge 130 meeting the tabs 140 on the respective sides;

The ear panels 140 between adjacent leaflets 100 are connected to each other by a first suture 174 and also connected to a support strip 220 by a second suture 176 and a third suture 178, wherein all of the knots 182 in the second suture 176 and the third suture 178 are located in corresponding recessed areas 221.

The configuration of the leaflets and the manner of sewing may of course also be combined with the previous embodiments, for example, where the tabs 140 between adjacent leaflets 100 are interconnected by first stitches 174 against the radially inner side of support band 220. Tabs 140 between adjacent leaflets 100 cooperatively wrap around support strips 220. The knot 181 in the second suture 176 is wrapped by the tab 140 and the knot 182 in the third suture 178 is exposed to the tab 140.

Axially opposite sides of the rack 210 are opposite inflow and outflow sides, wherein a ring of hexagonal cells is circumferentially arranged at the outflow side, and the support bar 220 serves as a common edge between two of the adjacent cells. To accommodate the securement of tab 140, support bar 220 extends axially from support 210.

In this embodiment, the prosthetic heart valve 200 can also include an inner skirt that can be coupled to the leaflet 100.

Further, to address the perileak problem, the prosthetic heart valve 200 may also include a perileak prevention assembly that may be connected to the inflow side of the stent.

In one embodiment, the peripheral leakage prevention assembly may be an outer skirt, which may be secured to the outside of the bracket. The material of the outer skirt may be biological tissue, such as pericardium, or may be a polymeric material, such as PET, or the like.

In another embodiment, referring to fig. 25, the peripheral leakage preventing assembly 300 is an integral structure, and includes a base 310 located on the inner side of the bracket and a peripheral leakage preventing member 320 fixed on the outer side of the base, where the peripheral leakage preventing member 320 may be a plurality of blocks distributed at intervals and located corresponding to the hollowed-out areas of the unit cells of the bracket. In the expanded state of the stent 210 after release, the leakage prevention member 320 extends radially outward from the corresponding cell along the stent or radially beyond the outer circumference of the stent to achieve a leakage prevention effect.

Based on the structural features of the artificial heart valve example in the above embodiments, referring to fig. 16, an embodiment of the present application further discloses a method for processing an artificial heart valve, which specifically includes:

Step S100, bending the joint part of the lug 140 and the body 110 to the inner side of the body 110 in the transverse direction, and mutually abutting against the body 110 to form a joint part 170 with a double-layer structure, wherein the outer flange 150 is folded in half on itself in the joint part 170;

referring to fig. 17 to 18, in step S100, the axis (L2 in the drawing) where the opening area 131 is located is a bending line, the tab 140 is bent clockwise (Z direction) toward the body 110 until the outer flange 150 is folded back on itself at the position of the bending line to form the joint 170, and then the joint 170 of the two leaflets 100 to be sewn to each other is abutted against each other, so that the two joint 170 are registered with each other.

Step 200, in a state that the joint portions 170 of two adjacent valve leaflets 100 are in abutting registration with each other, the outer flange 150 of the two valve leaflets 100 is sewn by using the first suture 174, and knotted and fixed on the top side of the outer flange 150 after the sewing;

referring to fig. 19, specifically, after the two joining portions 170 are registered, the first suture 174 is sequentially passed through the line holes 173a of the two outer flanges 150, at this time, the first suture 174 is passed through 4 layers in total, and then two ends of the first suture 174 are tied at the top side of the outer flange 150 to pre-fix the two joining portions 170.

Step S300, the first suture 174 is sewn and reinforced by threading the suture for a plurality of times at the joint 170 of two adjacent valve leaflets 100;

Referring to fig. 20, the suture reinforcement specifically includes a transverse reinforcement in which a suture is wound circumferentially around the periphery of the joint 170 through a hole where two joints 170 are abutted against, and a longitudinal reinforcement in which a suture is threaded between two adjacent holes. After the two joining portions 170 are pre-fixed, the first suture 174 is passed through the holes 173a and 173b respectively (the first suture 174 is only reinforced longitudinally at the hole 173 c), and the specific threading procedure may be the modified manner mentioned above or other prior art, and finally, the two ends of the first suture 174 are knotted and fixed again at the top side of the outer flange 150, and the two knots 180 are respectively located at the top sides of the two outer flanges 150.

Step S400, sewing the joint 170 of two adjacent leaflets 100 to the radially inner side of the stent with the second suture 176;

Referring to fig. 21, after the two outer flanges 150 are fixed using the first suture 174, the second suture 176 is then passed through the wire holes 175a, 175b, and 175c of the two coupling parts 170, respectively. When the number of the second stitches 176 is plural, the second stitches 176 pass through one of the thread holes (the thread hole 175a or the thread hole 175b or the thread hole 175 c) of the two bonding portions 170, that is, pass through 4 layers and then wind around the first recessed area 222 of the supporting bar 220 to perform knotting treatment, and hide the knots in the first recessed area 222. When the second suture 176 is a single suture, in order to avoid repeated winding, the second suture 176 is generally sewn from the top side to the bottom side (or sewn from the bottom side to the top side), passes through the wire holes 175a of the two combining parts 170, winds the supporting bar 220, and then knots in the first concave area 222a, passes through the wire holes 175b of the two combining parts 170, winds the supporting bar 220, knots in the first concave area 222b, and similarly passes through the wire holes 175c of the two outer protruding parts 150, winds the supporting bar 220, knots in the first concave area 222c, and completes the winding of the second suture 176.

Referring to fig. 22, in step S500, the tabs 140 of two adjacent leaflets 100 are bent to the lateral outside of the body 110 (in the X1 and X2 directions in the drawing) and extend to the radial outside of the stent to wrap the corresponding portion of the stent, and the wrapped portion is stitched and fixed to the stent by the third stitching 178.

Referring to fig. 23 to 24, in particular, when the third sutures 178 are multiple, the third sutures 178 respectively pass through the holes of the ear piece 140 and the bonding portion 170 and are then respectively knotted and fixed with the second recessed region 223 of the bracket. When the third suture 178 is single, taking the example of stitching from the top side to the bottom side of the ear piece 140, the third suture 178 penetrates into the line hole 177a of the ear piece 140, then penetrates into the line hole 175a of the joint portion 170, then penetrates out of the line hole 177a of the other ear piece (the third suture 178 penetrates through six layers once) to be knotted and fixed, the knot 182 is arranged in the second concave area 223a, then the third suture 178 continuously penetrates into the line hole 177b of the ear piece 140, then penetrates into the line hole 175b of the joint portion 170, then penetrates out of the line hole 175b of the other ear piece to be knotted and fixed in the second concave area 223b, and similarly, the third suture 178 continuously penetrates into the line hole 177c of the joint portion 170, then penetrates into the line hole 175c of the outer flange 150, and then penetrates out of the line hole 177c of the other ear piece to be knotted and fixed in the second concave area 223c, and thus the stitching of the stent and the two adjacent leaflets 100 is completed.

The application makes corresponding improvement on the valve leaflet and the suturing mode, ensures the sealing effect on blood flow control and the connection strength of the valve leaflet and the bracket, solves the delivery problems of convex line knot and the like, and reduces the potential safety hazard.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description. When technical features of different embodiments are embodied in the same drawing, the drawing can be regarded as a combination of the embodiments concerned also being disclosed at the same time.

The above examples illustrate only a few embodiments of the application, which are described in detail and are not to be construed as limiting the scope of the claims. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the application, which are all within the scope of the application.

Claims (13)

1. The prosthetic heart valve is characterized by comprising a bracket and a plurality of valve leaflets connected to the bracket, wherein the bracket is of a cylindrical structure and is internally provided with a blood flow channel, and the valve leaflets comprise:

The body is provided with opposite transverse directions and longitudinal directions in a flattened state, the outer edge of the body comprises free edges and fixed edges which are distributed on two opposite sides in the longitudinal direction, the plurality of valve leaflets are fixed with the bracket through the respective fixed edges, and the free edges of the plurality of valve leaflets are matched with each other to control a blood flow channel in the artificial heart valve;

a tab disposed on opposite lateral sides of the body, the free edge and the fixed edge meeting at a tab on a respective side, the tab having:

the first bending part bends from the joint part of the lug and the body to the inner lateral side of the body and is mutually abutted with the body to form a joint part with a double-layer structure;

a second bending part which bends from the tail end of the first bending part to the outer lateral side of the body;

The combination parts between two adjacent valve blades are mutually stuck and sewed and fixed, and are propped and fixed on the radial inner side of the bracket, the second bending parts of the valve blades extend to the radial outer side of the bracket and wrap the corresponding parts of the bracket, and the second bending parts are sewed and fixed with the bracket at the wrapping parts.

2. The prosthetic heart valve of claim 1, wherein the tab is provided with an outer flange extending longitudinally relative to the free edge where it joins the free edge, the outer flange doubling back upon itself in the join.

3. The prosthetic heart valve of claim 2, wherein the bond between two adjacent leaflets is secured by a first suture, the first suture or sutures, all knots in the first suture being on the top side of the outer flange.

4. The prosthetic heart valve of claim 3, wherein the bond is longitudinally aligned with a plurality of wire holes, the first suture passing around each wire hole, the suture extending laterally outward of the body through the wire hole and wrapping around the bond for at least one of the wire holes.

5. The prosthetic heart valve of claim 2, wherein the bond is connected to the stent by a second suture.

6. The prosthetic heart valve of claim 5, wherein at least a portion of the stent is a support band, the second suture is looped around the support band, and a plurality of loops are looped along an extension of the support band.

7. The prosthetic heart valve of claim 6, wherein the second sutures each encircle a thread with one thread knot, all thread knots in the second sutures being laterally of the support band along the circumference of the stent.

8. The prosthetic heart valve of claim 7, wherein at least one side of the support band has a recessed region along a circumference of the stent, the knot in the second suture being within the recessed region.

9. The prosthetic heart valve of claim 6, wherein the second kink portions of adjacent leaflets wrap around the support band from opposite sides of the support band, the second kink portions being connected to the support band by a third suture, the knot in the third suture being laterally of the support band along the circumference of the stent.

10. The prosthetic heart valve of claim 9, wherein the support band has opposite sides along a circumference of the stent, one side having a first recessed area for placement of the knot of the second suture and the other side having a second recessed area for placement of the knot of the third suture.

11. The artificial heart valve is characterized by comprising a bracket and a plurality of valve leaflets connected to the bracket, wherein the bracket is of a cylindrical structure and is internally provided with a blood flow channel;

At least one part of the support is a support bar, at least one side of the support bar is provided with a concave area along the circumferential direction of the support bar, the valve leaflet is fixed with the support bar through a suture, and all knots in the suture are positioned in the corresponding concave area.

12. The prosthetic heart valve of claim 11, wherein the stent is axially flanked by opposing inflow and outflow sides, wherein a ring of hexagonal cells are circumferentially disposed on the outflow side, the support band acting as a common edge between two of the cells.

13. A method of manufacturing a prosthetic heart valve, comprising:

bending the joint part of the lug and the body to the inner side of the body in the transverse direction, and mutually abutting the lug and the body to form a joint part with a double-layer structure, wherein the outer part is folded in half by itself in the joint part;

the method comprises the steps that under the state that the combined parts of two adjacent valve leaflets are in abutting registration with each other, the outer convex parts of the two valve leaflets are stitched by using a first suture line, and knotted and fixed on the top side of the outer convex parts after stitching;

Threading the suture lines for a plurality of times at the joint parts of two adjacent valve leaflets to carry out suture reinforcement;

sewing the joint of two adjacent leaflets to the radially inner side of the stent using a second suture;

the lugs of two adjacent valve blades are bent towards the transverse outer side of the body and extend to the radial outer side of the support to fold the corresponding parts of the support, and the folded parts are sewn and fixed with the support by a third suture.