CN112022441A

CN112022441A - Heart valve and valve conveying device

Info

Publication number: CN112022441A
Application number: CN202010967331.8A
Authority: CN
Inventors: 王洪志
Original assignee: Individual
Current assignee: Individual
Priority date: 2020-09-15
Filing date: 2020-09-15
Publication date: 2020-12-04

Abstract

The invention relates to the field of medical equipment, in particular to a heart valve and a valve conveying device. The heart valve comprises a valve stent and connecting claws, one end of the valve stent is connected with a plurality of connecting claws, and the connecting claws are used for being connected with a delivery device for delivering the heart valve; when the valve stent and the connecting claws are contracted to be suitable for being installed in the delivery device, the connecting claws are arranged in a staggered mode in the height direction of the valve stent; in the process of placing the valve stent into the heart, the connecting claws are separated from the conveying device in order according to the distance from the valve stent, so that sudden jump caused by one-time complete release of the valve stent can be avoided, and mechanical transmission is stable in the release process, so that the heart valve is positioned more accurately; the valve support is saddle-shaped, so that the valve can be better inosculated with the native structure of the heart of a human body.

Description

Heart valve and valve conveying device

Technical Field

The invention relates to the field of medical equipment, in particular to a heart valve and a valve conveying device.

Background

The human heart is one of the most important organs in the body and has the main function of providing pressure for the blood flow to move the blood to various parts of the body. The heart is divided into left and right parts, each part including a ventricle and an atrium, the ventricle and atrium being separated by a ventricular septum and an atrial septum, with valves between the atrium, chamber and artery to prevent regurgitation of blood. Wherein the valve located between the left atrium and the left ventricle is the mitral valve and the valve located between the left ventricle and the aorta is the aortic valve.

Among them, mitral valve lesions are easily invaded valvular lesions of various diseases including rheumatic heart disease, congenital heart disease, infectious endocarditis, senile degenerative heart disease, etc., and can be divided into two types, stenosis and incompetence. Pathological changes caused by various pathogenic factors invading the mitral valve, such as fibrous thickening of the valve, plaque formation and even calcification, and junction fusion, which cause the valve orifice to be narrow and form simple mitral stenosis; or causing valve mucoid degeneration, chordae elongation or rupture, and valve relaxation, resulting in mitral insufficiency. The patients with mild lesion and good cardiac function compensation can have no obvious symptoms. Severe or prolonged pathological changes may cause symptoms such as lassitude, palpitation, and shortness of breath after fatigue.

The conventional surgical operation causes great pain to patients, has various complications and a long repair time, and even some patients do not allow the surgical operation at all due to their own conditions. The minimally invasive intervention of the mitral valve is gradually a trend of subverting the traditional surgical treatment due to the advantages of safety, effectiveness, minimal invasion and few complications.

However, in the prior art, when the artificial heart valve used in the minimally invasive interventional therapy of the mitral valve is placed in the heart, the heart valve may jump, the problems of inaccurate positioning, complication caused by the heart valve pressing on the heart, perivalvular leakage caused by poor anastomotic degree of the heart valve and the native valve annulus, and the like occur.

Disclosure of Invention

Therefore, the invention provides a heart valve, which is used for solving the problems that in the prior art, when the heart valve is placed in a heart, the heart valve beats, so that the heart valve is inaccurately positioned, the heart valve presses the heart to generate complications, the heart valve and native valve annulus have poor anastomosis degree, the valve is perivalvular leakage occurs, and the like.

The invention provides a valve delivery device which is used for delivering a heart valve to a designated position, can prevent the heart valve from beating and can accurately position the heart valve.

The invention provides a heart valve, which comprises a valve stent and connecting claws, wherein one end of the valve stent is connected with a plurality of connecting claws, and the connecting claws are used for being connected with a conveying device for conveying the heart valve;

when the valve stent and the connecting claws are contracted to be suitable for being installed in the delivery device, the connecting claws are arranged in a staggered mode in the height direction of the valve stent;

during the process of placing the valve stent into the heart, the connecting claws are separated from the delivery device according to the distance from the valve stent in order.

Optionally, the connecting claws comprise a first connecting claw and a second connecting claw, the first connecting claw is far away from the valve support relative to the second connecting claw;

during the process of placing the valve stent into the heart, the first connecting claw or the second connecting claw is separated from the conveying device firstly.

Optionally, the transverse direction of the valve stent comprises a stent front part and a stent rear part, the stent front part and the stent rear part are connected, the stent front part is positioned at one side close to the aortic valve, and the stent rear part is positioned at the other side far away from the aortic valve;

in the cross section perpendicular to the height direction of the valve support, the front portion of the support is in an elliptic arc shape, the rear portion of the support is in an arc shape, and the front portion of the support is tangent to the rear portion of the support.

Optionally, the heart valve further comprises a medial stent connected with the valve stent and positioned inside the valve stent;

in the section perpendicular to the height direction of the valve support, the section of the inner support is the same as that of the valve support, or the section of the inner support is circular.

Optionally, in the height direction of the valve support, the height of one end of the valve support close to the aortic valve is a front height, the height of one end far away from the aortic valve is a rear height, and the height of the middle part between one end close to the aortic valve and one end far away from the aortic valve is a middle height;

the front height is greater than the rear height, which is greater than the middle height.

Optionally, in the height direction of the valve stent, the valve stent comprises an atrium section, a vertical section, a conical section and a connecting section which are connected in sequence, and the connecting section is provided with the connecting claws;

the height of one end of the vertical section close to the aortic valve is the annular front height, the height of one end far away from the aortic valve is the annular back height, and the height of the middle part between one end close to the aortic valve and one end far away from the aortic valve is the annular middle height;

the conical section is in a table shape, and the height of the conical section is the height of the conical section;

the farthest distance from the connecting claws to the valve support is the height of the connecting section;

the anterior annulus height, the taper section height, the connector section height, and the sum of the heights h21, the mid-annulus height, the taper section height, the connector section height, and the sum of the heights h22, the posterior annulus height, the taper section height, the connector section height, and the sum of the heights h 23;

h21>h23>h22。

optionally, in a lateral direction of the valve stent, the vertical section and/or the tapered section comprises a first front portion and a first back portion, the first front portion and the first back portion are connected, the first front portion is located on one side close to an aortic valve, and the first back portion is located on the other side far from the aortic valve;

in a cross section perpendicular to the height direction of the valve support, the first front portion is in an elliptic arc shape, an arc groove which is sunken towards the center direction of the elliptic arc shape is formed in the middle of the elliptic arc shape, the first rear portion is in an arc shape, and the first front portion is tangent to the first rear portion.

Optionally, the vertical section includes a vertical portion enclosed into a column, and an included angle al between an outer wall of the tapered section and an outer wall of the vertical portion is: 0 ° < al <90 °; and/or the presence of a gas in the gas,

the angle a3 between the outer wall of the atrial section and the outer wall of the vertical portion is: 0 < a3< 180.

Optionally, the valve further comprises a valve leaflet, wherein the periphery of the valve leaflet comprises a apposition line and a suture line, the suture line is connected with the valve support or the inner support, the apposition line is contacted with the apposition line of other valve leaflets, and the apposition line is W-shaped.

Optionally, the valve holder further comprises one or more locking pieces, the locking pieces are connected with the outer wall of the valve holder, the locking pieces are long-shaped, and the locking pieces are used for being connected with valve leaflets of the heart;

the valve support comprises a grid structure, and two ends of the locking piece are connected with one corner of the same grid structure; or the like, or, alternatively,

two ends of the locking piece are respectively connected with two corners of the same grid structure; or the like, or, alternatively,

the two ends of the locking piece are respectively connected with the corners of the two grid structures arranged at intervals, and one corner of the grid structure between the two grid structures arranged at intervals is connected with the connecting claw.

The invention also provides a valve conveying device, which comprises an incoming tube, a connecting rod and an operating mechanism, wherein the incoming tube and/or the connecting rod is/are connected with the operating mechanism, the connecting rod is connected with the heart valve, and the incoming tube is used for installing the heart valve and the connecting rod;

the connecting rod is provided with a plurality of mounting parts, the mounting parts are used for mounting the connecting claws in a one-to-one correspondence manner, and the mounting parts are arranged in a staggered manner in the height direction of the valve support;

and in the process of placing the valve stent into the heart, the installation parts are separated from the connecting claws in order according to the distance from the valve stent.

According to the heart valve, when the valve support and the connecting claws are contracted to be suitable for being installed in the conveying device, the connecting claws are arranged in the height direction of the valve support in a staggered mode, the valve support and the conveying device are provided with a plurality of connecting positions, the connecting positions are not in the same plane, the force uniformity when the heart valve is arranged in the conveying device can be improved, and the mechanical transmission is stable in the retracting process; in the process of placing the valve stent into the heart, the connecting claws are separated from the conveying device in order according to the distance from the valve stent, the connecting claws are not separated from the conveying device at the same time, the connecting claws separated from the conveying device firstly can fix part of the valve stent with the native valve of the heart, and the connecting claws separated from the conveying device later can fix the rest part of the valve stent in order with the native valve of the heart, so that sudden jump caused by one-time complete release of the valve stent can be avoided, mechanical transmission is stable in the release process, and the heart valve is positioned more accurately.

The foregoing description is only an overview of the technical solutions of the present invention, and the embodiments of the present invention are described below in order to make the technical means of the present invention more clearly understood and to make the above and other objects, features, and advantages of the present invention more clearly understandable.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.

FIG. 1 is a schematic, perspective view of a heart valve of the present invention;

FIG. 2 is a schematic structural diagram of a top view of FIG. 1;

FIG. 3 is a schematic view of the attachment of the heart valve and delivery device of the present invention;

FIG. 4 is an enlarged view of portion A of FIG. 3;

FIG. 5 is a second structural view of the connecting claw of FIG. 4;

FIG. 6 is a third structural view of the connecting claw of FIG. 4;

FIG. 7 is a schematic front view of the valve stent of FIG. 1;

FIG. 8 is a top view of FIG. 7;

FIG. 9 is a schematic view of the first embodiment of the valve stent of FIG. 8;

FIG. 10 is a schematic diagram of the valve stent concept of FIG. 8;

FIG. 11 is a first schematic view illustrating the configuration of the valve stent of FIG. 1;

FIG. 12 is a second schematic structural illustration of the valve stent of FIG. 1;

FIG. 13 is a schematic structural illustration of the atrial segment of FIG. 12;

FIG. 14 is a schematic top plan view of the atrial and vertical segments of FIG. 12;

FIG. 15 is a first schematic structural view of a top view of the cone segment of FIG. 12;

FIG. 16 is a schematic top view of a tapered section in accordance with another embodiment;

FIG. 17 is an enlarged view of portion B of FIG. 7;

FIG. 18 is an enlarged view of portion C of FIG. 7;

FIG. 19 is a front elevational view of the medial support of FIG. 1;

FIG. 20 is a first schematic structural view of the top view of FIG. 19;

FIG. 21 is a second schematic structural view of the top view of FIG. 19;

FIG. 22 is a schematic view of a valve stent of the present invention with locking elements;

FIG. 23 is the first drawing of the right side view of FIG. 22;

FIG. 24 is a second schematic structural view of the right side view of FIG. 22;

FIG. 25 is a third schematic view of the right side view of FIG. 22;

FIG. 26 is a fourth schematic structural view of the right side view of FIG. 22;

FIG. 27 is a schematic structural view of a perspective view of the lobe of FIG. 2;

FIG. 28 is a schematic view of the structure of the heart;

fig. 29 is an enlarged view of portion D of fig. 28;

FIG. 30 is a schematic view of a valve stent of the present invention after placement in the heart;

FIG. 31 is a schematic view of a prior art valve stent after placement in a heart;

FIG. 32 is a schematic view of the structure of the conveying apparatus of the present invention;

FIG. 33 is a first view of an enlarged view of portion E of FIG. 32;

FIG. 34 is a second schematic view of the enlarged view of portion E in FIG. 32;

description of reference numerals:

1-a heart valve;

11-a valve stent; 111-the front of the rack; 112-the back of the bracket; 113-connecting claws; 1131 — first coupling claw; 1132 — a second coupling claw; 1141-atrial segment; 1142-a vertical section; 11421-a first component; 11422-a second component; 1143-a tapered section; 1144-a linker segment; 1151-atrial anterior height; 1152-atrial posterior height; 1153-atrial mid-height; 1161-anterior annulus height; 1162-annulus posterior height; 1163-annulus mid-height; 1171-elliptical-arc; 1172-arc shaped; h 11-front height; h 12-middle height; h 13-rear height; 1181-a first front portion; 1182-a first rear portion; 1183-circular arc groove;

121-first development point; 122-second development point; 123-third development point;

13-medial support;

14-a leaflet; 141-knit line; 142-a suture thread;

15-barbs;

161-a first petal skirt; 162-a second petal skirt;

17-a locking element;

2-a conveying device; 21-a first input pipe; 22-a second input pipe; 221-a first mounting portion; 222-a second mounting portion; 223-a third mounting portion; 224-a fourth mounting portion; 225-fifth mount; 23-a first hand wheel; 24-a second hand wheel; a 25-luer fitting; 26-conveying the outer tube; 27-a housing; 28-a connecting rod;

3-the heart; 31-left atrium; 32-left ventricle; 33-mitral valve; 331-mitral anterior leaflet; 332-posterior leaflet of mitral valve; 34-aortic valve.

Detailed Description

The technical solutions of the present invention will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are some, but not all embodiments of the present invention. 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 invention.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

As shown in fig. 1 to 7, an embodiment of the present invention provides a heart valve 1, including a valve stent 11 and a plurality of connecting claws 113, wherein one end of the valve stent 11 is connected to the plurality of connecting claws 113, the connecting claws 113 are used for connecting with a delivery device for delivering the heart valve, and when the valve stent 11 and the connecting claws 113 are contracted to be suitable for being loaded into the delivery device, the plurality of connecting claws 113 are arranged in a staggered manner in the height direction of the valve stent 11;

during the insertion of the valve stent 11 into the heart 3, the plurality of connecting claws 113 are sequentially separated from the delivery device by the distance from the valve stent 11.

Specifically, the heart valve 1 is mainly directed to minimally invasive replacement after the lesion of the native heart valve, taking the mitral valve 33 as an example in the native heart valve, the position of the mitral valve 33 in the heart 3 is shown in fig. 28 and 29, the mitral valve 33 has 2 leaflets, the anterior mitral valve leaflet 331 is located on the side close to the aortic valve 34, and the posterior mitral valve leaflet 332 is located on the side far from the aortic valve 34.

The valve support 11 is a support structure of the heart valve 1, and the shape of the heart valve 1 is the same as that of the valve support 11. When the heart valve 1 is fixed to the heart 3, the valve holder 11 is fixed to the mitral valve 33.

As shown in fig. 7 and 18, in one embodiment, to increase the stability of the fixation of the valve holder 11 to the mitral valve 33, barbs 15 are provided on the valve holder 11. The end of the barb 15 remote from the valve holder 11 is arrow-shaped.

The barbs 15 are used to fix the valve holder 11 to the mitral valve 33, and make the fixation strength and reliability of the heart valve 1 and the mitral valve 33 high.

The connecting claws 113 are used for being connected with a conveying device 2 for conveying the heart valve 1, the connecting claws 113 are connected with one end of the valve support 11, when the valve support 11 and the connecting claws 113 are contracted to be suitable for being installed in the conveying device, the connecting claws 113 are arranged in a staggered mode in the height direction of the valve support 11, the valve support 11 and the conveying device are provided with a plurality of connecting positions, the connecting positions are not in the same plane, the force uniformity when the heart valve is arranged in the conveying device can be improved, the mechanical transmission is stable in the retraction process, the retraction performance of the heart valve 1 is greatly improved, and the reliability of connection of the heart valve 1 and the conveying device 2 can be improved; in the process of placing the valve stent 11 into the heart 3, the plurality of connecting claws 113 are separated from the conveying device in order according to the distance from the valve stent 11, the plurality of connecting claws 113 are not separated from the conveying device 2 at the same time, the connecting claws 113 separated from the conveying device firstly can fix the part of the valve stent 11 and the mitral valve 33, and the connecting claws 113 separated from the conveying device later can fix the rest part of the valve stent 11 in order and the mitral valve 33, so that sudden jump caused by once and complete release of the valve stent 11 can be avoided, the mechanical transmission is stable in the release process, and the heart valve is positioned more accurately.

Other orders of separating the plurality of coupling claws 113 from the conveying device, such as in the order of circumferential arrangement of the plurality of coupling claws 113, may be sufficient if the coupling claws 113 are not separated from the conveying device at the same time.

Because valve support 11 and connecting claw 113 shrink to be suitable for when packing into conveyor, a plurality of connecting claws 113 are crisscross setting in the direction of height of valve support 11, and the length that a plurality of connecting claws 113 occupy the direction of height of valve support 11 of conveyor 2 is long, and corresponding circumferential area who occupies conveyor 2 is little, and then makes the diameter of conveyor 2 and valve support 11 connection one end little, and the wound that the wicresoft replacement needs is little, can alleviate the wound that the operation in-process caused to the human body.

The valve stent 11 is made of memory alloy, stainless steel, cobalt-chromium alloy, high polymer and other materials so as to adapt to the shape change of the valve stent 11 in the process of being placed into the heart 3 and in the working process.

As shown in fig. 3, the arrow direction is the height direction of the valve holder 11; as shown in fig. 7, the direction of the dotted line is also the height direction of the valve holder 11.

The structure of the connecting claw 113 is determined according to the use requirement, the connecting claw 113 shown in fig. 4 is a connection of a vertical rod and a square plate, the connecting claw 113 shown in fig. 5 is a connection of a vertical rod and a trapezoidal plate, and the connecting claw 113 shown in fig. 6 is a connection of a vertical rod and an arc plate.

The number of the connecting claws 113 is set according to the use requirement, and is not limited to the number of the connecting claws 113 shown in the figure.

As shown in fig. 1 and 4, in an embodiment, the connection claws 113 include first connection claws 1131 and second connection claws 1132, the plurality of first connection claws 1131 and the plurality of second connection claws 1132 are arranged alternately in the height direction of the valve holder 11, and the first connection claws 1131 are far away from the valve holder 11 relative to the second connection claws 1132; during deployment of the valve stent 11 into the heart 3, the first coupling claws 1131 are first separated from the delivery device 2, and the second coupling claws 1132 are then separated from the delivery device 2.

In another embodiment, the second coupling claw 1132 is first separated from the delivery device 2 and the first coupling claw 1131 is then separated from the delivery device 2 during deployment of the valve stent 11 into the heart 3.

As shown in fig. 4, since the first coupling claws 1131 and the second coupling claws 1132 are arranged in a staggered manner in the height direction of the valve stent 11, on the premise of ensuring the stability of connection between the heart valve 1 and the delivery device 2, the diameters required for connection between the delivery device 2 and the coupling claws 113 can be reduced, and then the diameters of the portions of the delivery device 2 extending into the human body can be reduced, so that the wound required for minimally invasive replacement is small, and the wound caused to the human body in the operation process can be reduced.

As shown in fig. 4, in an embodiment, the first coupling claws 1131 and the second coupling claws 1132 are distributed at intervals and are uniformly distributed, the uniformity of the coupling between the first coupling claws 1131 and the second coupling claws 1132 and the conveying device 2 is better, and the mechanical transmission is stable during the mounting process and the separation process of the first coupling claws 1131 and the second coupling claws 1132 and the conveying device 2.

As shown in fig. 7 to 10, in one embodiment, the transverse direction of the valve stent 11 includes a stent front part 111 and a stent rear part 112, the stent front part 111 and the stent rear part 112 are connected, the stent front part 111 is located on one side close to the aortic valve 34, and the stent rear part 112 is located on the other side far from the aortic valve 34; in a cross section perpendicular to the height direction of the valve holder 11, the holder front part 111 is in an elliptical arc 1171, the holder rear part 112 is in a circular arc 1172, and the holder front part 111 is tangent to the holder rear part 112.

The lateral direction of the valve holder 11 is the direction of the arrow in fig. 7, and is perpendicular to the height direction of the valve holder 11.

After the heart valve 1 is placed in the heart 3, the stent front part 111 is arranged corresponding to the mitral valve anterior leaflet 331, and the stent rear part 112 is arranged corresponding to the mitral valve posterior leaflet 332.

As shown in fig. 9 and 10, the connection between the elliptical arc 1171 and the circular arc 1172 is schematically illustrated. The distance between the center of the elliptical arc 1171 and the center of the circular arc 1172 is t, and t is more than or equal to 0 and less than or equal to 30 mm. The range of the distance t enables the heart valve 1 to be adapted for interventional treatment of mitral valves 33 of different individuals.

The shape of the valve ring of the mitral valve 33 in the whole heart 3 cycle is changed, in the section perpendicular to the height direction of the valve support 11, the front part 111 of the support is an elliptical arc 1171, the rear part 112 of the support is an arc 1172, the front part 111 of the support is tangent to the rear part 112 of the support, the outlines of the heart valve 1 and the valve support 11 can adapt to the valve ring shape of the whole heart 3 cycle, and the compression of the heart valve 1 on human tissues can be reduced as much as possible; and the heart valve 1 has good inosculation with the mitral valve 33, and a gap is not formed between the heart valve 1 and the mitral valve 33, thereby avoiding paravalvular leakage and reducing the occurrence probability of complications.

As shown in fig. 1, 2, 19 and 20, in one embodiment, the heart valve further comprises an inner stent 13, the inner stent 13 being connected to the valve stent 11 and located inside the valve stent 11; in a cross section perpendicular to the height direction of the valve holder 11, the cross section of the inner holder 13 is the same as the cross section of the valve holder 11.

As shown in fig. 1, 2, 19 and 21, in one embodiment, the cross section of the inner holder 13 is circular in a cross section perpendicular to the height direction of the valve holder 11.

The shape of the inner support 13 in the height direction of the valve support 11 needs to be matched with the shape of the valve support 11, the inner support 13 needs to deform along with the valve support 11 in the transverse direction of the valve support 11, and as the shape of the valve ring in the whole heart 3 period is changed, the section of the inner support 13 is set to be the same as the section of the valve support 11, or the section of the inner support 13 is circular, so that the shape of the valve ring in the whole heart 3 period can be matched with the shape of the valve ring.

The material of the inner stent 13 is the same as that of the valve stent 11, and is also memory alloy, stainless steel, cobalt-chromium alloy, polymer, or the like.

As shown in fig. 7, in one embodiment, the height of the valve stent 11 is defined by a front height h11 at one end of the valve stent 11 close to the aortic valve 34, a rear height h13 at one end far from the aortic valve 34, and a middle height h12 at the middle between the end close to the aortic valve 34 and the end far from the aortic valve 34; the front height h11 is greater than the rear height h13, and the rear height h13 is greater than the middle height h 12.

As shown in fig. 7 and 11, the left side of the valve stent 11 is close to the aortic valve 34 and the right side is far from the aortic valve 34, and the height of the valve stent 11 in the dotted line portion of fig. 7 is the middle height h 12.

As shown in fig. 7, the upper and lower end surfaces of the valve holder 11 are in smooth transition, the valve holder 11 is saddle-shaped, and the front height h11 and the rear height h13 are both greater than the middle height h12, so that when the valve holder 11 deforms along with the mitral valve 33, the obstruction of the middle part of the upper end of the valve holder 11 on the shape change of the valve holder 11 is small, the valve holder 11 is more likely to change along with the shape change of the mitral valve 33, the compliance of the heart valve 1 in the deformation process along with the mitral valve 33 is improved, the compression on the mitral valve 33 is reduced, and the incidence of diseases is reduced.

The anterior height h11 is greater than the posterior height h13, allowing better compliance of the heart valve 1 during deformation with the mitral valve 33.

And as shown in fig. 30 and fig. 31, since the shape of the valve holder 11 is consistent with that of the mitral valve 33 in the heart 3 cycle, the volume occupation of the heart valve 1 on the left atrium 31 is reduced, so as to reduce the pulmonary vein pressure (clinically, since the volume of the left atrium 31 of the human body is small, blood flows into the left atrium 31 from the pulmonary veins, if the volume of the left atrium 31 occupied by the prosthetic valve is large, pulmonary vein hypertension is caused, and certain damage is caused to the pulmonary veins of the human body), that is, in the volume of the left atrium 31, s2> s 1.

In one embodiment, as shown in fig. 11 and 12, in the height direction of the valve stent 11, the valve stent 11 comprises an atrial section 1141, a vertical section 1142, a conical section 1143 and a connecting section 1144 which are connected in sequence, and the connecting section 1144 is provided with a connecting claw 113;

the vertical section 1142 has an anterior annular height 1161 at an end adjacent to the aortic valve 34, a posterior annular height 1162 at an end distal to the aortic valve 34, and a mid-annular height 1163 midway between the end adjacent to the aortic valve 34 and the end distal to the aortic valve 34;

the conical section 1143 is in a truncated shape, and the height of the conical section 1143 is the height of the conical section;

the farthest distance from the connecting claws 113 to the valve stent 11 is the connecting section height;

the annular anterior height 1161, the conical segment height, the connecting segment height sum to h21, the annular middle height 1163, the conical segment height, the connecting segment height sum to h22, the annular posterior height 1162, the conical segment height, the connecting segment height sum to h 23; h21> h23> h 22.

As shown in fig. 12, the saddle-shaped curve locations of the valve stent 11 are located in the atrial section 1141 and the conical section 1143, i.e., both the atrial section 1141 and the conical section 1143 are saddle-shaped, and the saddle shape of the valve stent 11 is formed by the atrial section 1141 and the conical section 1143.

The tapered section 1143 is mesa-shaped, which means that the two ends of the tapered section 1143 in the height direction of the valve stent 11 are arranged in parallel.

Referring to fig. 7 and 16, in one embodiment, in a transverse direction of the valve holder 11, the tapered section 1143 includes a first front portion 1181 and a first rear portion 1182, the first front portion 1181 is connected to the first rear portion 1182, the first front portion 1181 is located on one side close to the aortic valve 34, and the first rear portion 1182 is located on the other side away from the aortic valve 34;

in a cross section perpendicular to the height direction of the valve holder 11, the first front portion 1181 is an elliptical arc 1171, the middle portion of the elliptical arc 1171 is provided with an arc groove 1183 recessed towards the center direction of the elliptical arc 1171, the first rear portion 1182 is an arc 1172, and the first front portion 1181 is tangent to the first rear portion 1182.

In another embodiment, the transverse direction of the valve holder 11, the vertical section 1142 and the tapered section 1143 each include a first front portion 1181 and a first back portion 1182, the first front portion 1181 and the first back portion 1182 are connected, the first front portion 1181 is located on one side close to the aortic valve 34, and the first back portion 1182 is located on the other side away from the aortic valve 34;

In another embodiment, it is vertical section 1142 that includes a first front portion 1181 and a first rear portion 1182.

The arc groove 1183 is configured to provide an avoidance space for the left ventricle 32 to flow out to the aortic valve 34, so as to reduce blockage, and make the blood flow smoother.

As shown in fig. 7 and 12, in an embodiment, the vertical section 1142 includes a vertical portion enclosing a column, and an included angle al between an outer wall of the tapered section 1143 and an outer wall of the vertical portion is: 0 ° < al <90 °; and/or the presence of a gas in the gas,

as shown in fig. 7 and 13, in one embodiment, the angle a3 between the outer wall of atrial segment 1141 and the outer wall of the upright is: 0 < a3< 180.

As shown in fig. 7 and 17, the vertical section 1142 includes a first member 11421 and a second member 11422, and one first member 11421 and two second members 11422 are connected, wherein the first member 11421 is parallel to the height direction of the valve stent 11.

As shown in fig. 1 and 2, in one embodiment, the heart valve further comprises a connector, the atrial section 1141 and the vertical section 1142 are separate structures, and the atrial section 1141 and the vertical section 1142 are connected by the connector.

The atrial section 1141 and the vertical section 1142 are separate structures, and compared with the atrial section 1141 and the vertical section 1142 which are integrally formed, the atrial section 1141 and the vertical section 1142 are softer, and the compliance of the atrial section 1141 and the vertical section 1142 in the deformation process along with the mitral valve 33 is increased.

As shown in fig. 27, in an embodiment, the leaflet 14 is further included, the outer circumference of the leaflet 14 includes a apposition line 141 and a suture 142, the suture 142 is connected with the valve support 11 or the inner support 13, the apposition line 141 is in contact with the apposition line 141 of other leaflets 14, and the apposition line 141 is W-shaped.

The design of the valve leaflet 14 adopts a W shape, and reduces the stress concentration at the top when the valve leaflet 14 is connected with the inner bracket 13. And also makes the leaflet 14 reliable in apposition with the leaflet 14.

The material of the valve leaflet 14 is porcine pericardium or bovine pericardium and the like.

As shown in fig. 22 to 26, in one embodiment, the valve holder 11 further includes locking pieces 17, the locking pieces 17 are connected to the outer wall of the valve holder 11, the locking pieces 17 are elongated, the locking pieces 17 are used for connecting with the valve leaflets 14 of the heart, and the number of the locking pieces is not limited.

As shown in FIG. 23, in one embodiment, the valve stent 11 comprises a lattice structure, and the two ends of the locking member 17 are connected to one corner of the same lattice structure.

As shown in fig. 24, in one embodiment, the locking member 17 is connected to the connecting section 1144. The two ends of the locking piece 17 are respectively connected with one corner of two adjacent grids of the valve support 11.

In one embodiment, as shown in fig. 25, the two ends of the locking member 17 are connected to two corners of the same lattice of the valve holder 11.

As shown in fig. 26, in one embodiment, both ends of the locking member 17 are connected to corners of two spaced grid structures, and a connecting claw 113 is connected to one corner of the grid structure between the two spaced grid structures.

In one embodiment, the angle between the valve holder 11 and the aortic valve 34 is a-2 in fig. 30, and the angle between the valve holder 11 and the aortic valve 34 is a-1 in fig. 31, and the heart valve 1 has less obstruction to the aortic valve 34 from the outflow tract of the left ventricle 32 due to a-2> a-1, so that the blood flow is smoother.

As shown in FIG. 2, in one embodiment, the heart valve 1 further includes three visualization points, which are located at both ends of the elliptical arc 1171 and at the center of the stent posterior portion 112.

As shown in fig. 2, the three development points are a first development point 121, a second development point 122, and a third development point 123, respectively, the first development point 121 and the second development point 122 are located at both ends of the arc portion, respectively, and the third development point 123 is located at the middle of the arc 1172. The visualization points serve to indicate the position of the heart valve 1 in the body, so that the heart valve 1 can be inserted in the heart 3 in a quasi-defective manner.

The material of the development point is foil, silver, tantalum, and the like, and can be used for the material of development.

In one embodiment, the number of the developing points is two, four or five, and the number of the developing points is set as required.

As shown in fig. 1, in an embodiment, the heart valve 1 comprises a first skirt 161 and a second skirt 162, the first skirt 161 being connected to the valve holder 11 and the second skirt 162 being connected to the inner holder 13.

The first valve skirt 161 and the second valve skirt 162 are made of cloth or bovine pericardium, porcine pericardium, and the like.

The first petal skirt 161 can serve as a connecting element, and the atrial section 1141 and the vertical section 1142 are connected by the first petal skirt 161.

In one embodiment, the valve stent 11, the inner stent 13, the first valve skirt 161, the second valve skirt 162, the valve leaflet 14 and the visualization point are connected in a manner that the valve stent 11 and the inner stent 13 are connected by welding, bonding or the like, the valve stent 11 and the first valve skirt 161 are sewn together by a seam, the inner stent 13 and the second valve skirt 162 are sewn together by a seam, the inner stent 13 and the valve leaflet 14 are sewn together by a seam, and the first visualization point 121, the second visualization point 122 and the third visualization point 123 are all connected with the valve stent 11 by welding, bonding or the like. The materials of the suture line are PE, high molecular polyester, PTFE, PP, PA and the like.

In one embodiment, the heart valve 1 does not include the medial stent 13, the leaflets 14 are directly connected to the valve stent 11, and the first skirt 161 and the leaflets 14 are sewn to the valve stent 11.

As shown in fig. 32-34, an embodiment of the present invention further provides a valve delivery device 2, comprising a receiving tube, a connecting rod 28 and an operating mechanism, wherein the receiving tube and/or the connecting rod 28 is connected with the operating mechanism, the connecting rod 28 is connected with the above heart valve, and the receiving tube is used for installing the heart valve and the connecting rod 28;

the connecting rod 28 is provided with a plurality of mounting parts, the mounting parts are used for mounting the connecting claws 113 in a one-to-one correspondence manner, and the mounting parts are arranged in a staggered manner in the height direction of the valve support 11;

during the insertion of the valve stent 11 into the heart 3, the plurality of mounting portions are sequentially separated from the connecting claws 113 by a distance from the valve stent 11.

Because the connecting claws 113 and the mounting part are provided with a plurality of connecting positions which are not in the same plane, the force uniformity of the heart valve arranged in the conveying device can be increased, the mechanics transmission is stable in the retraction process, the retraction performance of the heart valve 1 is greatly improved, and the reliability of the connection of the heart valve 1 and the conveying device 2 can be increased; in the process of placing the valve support 11 into the heart 3, the installation parts are sequentially separated from the connecting claws 113 according to the set sequence, the installation parts are not simultaneously separated from the connecting claws 113, the connecting claws 113 separated from the installation parts firstly can fix the part of the valve support 11 with the mitral valve 33, and the connecting claws 113 separated from the installation parts later can fix the rest part of the valve support 11 with the mitral valve 33 in sequence, so that sudden jump caused by once complete release of the valve support 11 can be avoided, the mechanical transmission is stable in the release process, and the heart valve is positioned more accurately.

And because the installation department sets up at the direction of height of valve support 11 crisscross, the length that a plurality of installation departments occupy the direction of height of connecting rod 28 is long, and the corresponding circumferential area that occupies connecting rod 28 is little, and then makes the diameter of connecting rod 28 little, and the wound that the wicresoft replacement needs is little, can alleviate the wound that the operation in-process caused to the human body.

As shown in fig. 32, the receiving pipes include a first receiving pipe 21 and a second receiving pipe 22.

As shown in fig. 33, the mounting portion includes a first mounting portion 221 and a second mounting portion 222, and the first mounting portion 221 is distant from the operating mechanism of the conveying device.

As shown in fig. 34, the mounting portions include a third mounting portion 223, a fourth mounting portion 224, and a fifth mounting portion 225, the fifth mounting portion 225 being remote from the operating mechanism of the transport apparatus.

In one embodiment as shown in fig. 32, the operating mechanism includes a first handwheel 23, a second handwheel 24, a luer connector 25, an outer conveying pipe 26 and a housing 27, the first handwheel 23, the second handwheel 24, the luer connector 25 and the outer conveying pipe 26 are all connected with the housing 27, the first receiving pipe 21 and the second receiving pipe 22 enter the housing 27 and extend out from the outer conveying pipe 26, and the first handwheel 23 and the second handwheel 24 are respectively used for operating the first receiving pipe 21 and the second receiving pipe 22 to realize the actions of the first receiving pipe 21 and the second receiving pipe 22.

The first receiving tube 21 and/or the second receiving tube 22 are also provided with visualization points for circumferentially positioning the heart valve 1 before the heart valve 1 is released, the number of the visualization points is the same as that of the visualization points on the heart valve 1, and the circumferential position corresponds to that of the visualization points on the heart valve 1.

It should be understood that the above examples are only for clarity of illustration and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. And obvious variations or modifications therefrom are within the scope of the invention.

Claims

1. A heart valve comprising a valve stent (11) and a plurality of connecting claws (113), one end of the valve stent (11) being connected to the plurality of connecting claws (113), the connecting claws (113) being adapted to be connected to a delivery device for delivering the heart valve,

when the valve stent (11) and the connecting claws (113) are contracted to be suitable for being installed in the delivery device, the connecting claws (113) are arranged in a staggered mode in the height direction of the valve stent (11);

during the process of placing the valve stent (11) into the heart (3), the connecting claws (113) are separated from the conveying device according to the distance order of the valve stent (11).

2. The heart valve according to claim 1, wherein the coupling jaws (113) comprise a first coupling jaw (1131) and a second coupling jaw (1132), the first coupling jaw (1131) being distal from the valve holder (11) with respect to the second coupling jaw (1132);

when the valve stent (11) is placed in the heart (3), the first connecting claw (1131) or the second connecting claw (1132) is separated from the conveying device firstly.

3. The heart valve according to claim 1 or 2, wherein the transverse direction of the valve stent (11) comprises a stent front part (111) and a stent rear part (112), the stent front part (111) and the stent rear part (112) being connected, the stent front part (111) being located on one side close to the aortic valve (34) and the stent rear part (112) being located on the other side away from the aortic valve (34);

in a cross section perpendicular to the height direction of the valve support (11), the support front part (111) is in an elliptic arc shape (1171), the support rear part (112) is in an arc shape (1172), and the support front part (111) is tangent to the support rear part (112).

4. A heart valve according to any one of claims 1-3, characterized in that the heart valve further comprises a medial stent (13), the medial stent (13) being connected to the valve stent (11), inside the valve stent (11);

in the section perpendicular to the height direction of the valve support (11), the section of the inner support (13) is the same as the section of the valve support (11), or the section of the inner support (13) is circular.

5. The heart valve according to any of claims 1-4, wherein the height of the valve holder (11), in the direction of the height of the valve holder (11), is the front height (h11) at the end of the valve holder (11) close to the aortic valve (34), the rear height (h13) at the end far from the aortic valve (34), and the middle height (h12) at the middle between the end close to the aortic valve (34) and the end far from the aortic valve (34);

the front height (h11) is greater than the rear height (h13), the rear height (h13) is greater than the middle height (h 12).

6. The heart valve according to any of claims 1 to 5, characterized in that the height direction of the valve support (11), the valve support (11) comprises an atrial section (1141), a vertical section (1142), a conical section (1143) and a connecting section (1144) which are connected in sequence, and the connecting section (1144) is provided with the connecting claw (113);

the vertical segment (1142) has an anterior annular height (1161) at an end adjacent to the aortic valve (34), a posterior annular height (1162) at an end distal to the aortic valve (34), and a mid-annular height (1163) midway between the end adjacent to the aortic valve (34) and the end distal to the aortic valve (34);

the conical section (1143) is in a table shape, and the height of the conical section (1143) is the height of the conical section;

the farthest distance from the connecting claw (113) to the valve stent (11) is the height of a connecting section;

the anterior annulus height (1161), the conical segment height, the connecting segment height, and the sum of heights h21, the mid-annulus height (1163), the conical segment height, the connecting segment height, and the sum of heights h22, the posterior annulus height (1162), the conical segment height, the sum of heights h 23;

h21>h23>h22。

7. the heart valve according to any of claims 1-6, wherein in a lateral direction of the valve holder (11), the vertical section (1142) and/or the tapered section (1143) comprises a first anterior portion (1181) and a first posterior portion (1182), the first anterior portion (1181) and the first posterior portion (1182) being connected, the first anterior portion (1181) being located on a side close to the aortic valve (34), the first posterior portion (1182) being located on another side away from the aortic valve (34);

in a cross section perpendicular to the height direction of the valve support (11), the first front portion (1181) is an elliptical arc (1171), an arc groove (1183) which is concave towards the center direction of the elliptical arc (1171) is arranged in the middle of the elliptical arc (1171), the first rear portion (1182) is an arc (1172), and the first front portion (1181) and the first rear portion (1182) are tangent.

8. A heart valve according to any one of claims 1-7, wherein the vertical section (1142) comprises a vertical portion enclosing a cylinder, and the angle al between the outer wall of the conical section (1143) and the outer wall of the vertical portion is: 0 ° < al <90 °; and/or the presence of a gas in the gas,

the angle a3 between the outer wall of the atrial segment (1141) and the outer wall of the upright is: 0 < a3< 180.

9. A heart valve according to any one of claims 1-8, wherein the valve holder (11) further comprises a lock (17), the lock (17) being connected to an outer wall of the valve holder (11), the lock (17) being elongated, the lock (17) being adapted to be connected to a leaflet (14) of the heart;

the valve support (11) comprises a grid structure, and two ends of the locking piece (17) are connected with one corner of the same grid structure; or the like, or, alternatively,

two ends of the locking piece (17) are respectively connected with two corners of the same grid structure; or the like, or, alternatively,

two ends of the locking piece (17) are respectively connected with the corners of two grid structures arranged at intervals, and one corner of the grid structure between the two grid structures arranged at intervals is connected with the connecting claw (113).

10. A valve delivery device comprising an access tube, a connecting rod (28) and an operating mechanism, the access tube and/or the connecting rod (28) being connected to the operating mechanism, the connecting rod (28) being connected to a heart valve according to any of claims 1-9, the access tube being adapted to receive the heart valve and the connecting rod (28);

the connecting rod (28) is provided with a plurality of mounting parts, the mounting parts are used for mounting the connecting claws (113) in a one-to-one correspondence manner, and the mounting parts are arranged in a staggered manner in the height direction of the valve support (11);

when the valve support (11) is placed in the heart (3), the installation parts are separated from the connecting claws (113) in order according to the distance from the valve support (11).