CN112754731A - Interventional artificial heart valve and medical device - Google Patents

Abstract

The invention relates to an intervention type artificial heart valve and a medical device, comprising a valve support and an anchoring part, wherein the valve support is provided with a body section and a skirt section at the inflow end, a valve leaf part is arranged in the body section, at least part of the outer surface of the skirt section is coated with a flexible annular sealing element, and the flexible annular sealing element comprises a material capable of absorbing blood; at least two connecting elements are arranged on one side of the outflow end of the body section, and the anchoring part is arranged around the periphery of the valve support and is detachably connected with the connecting elements. The invention adopts the non-closed annular anchoring part, improves the valve support structure, is suitable for being implanted into the left atrium or the right atrium of the heart of a human body through a catheter to replace the diseased mitral valve or tricuspid valve to perform functions, cannot damage the normal physiological functions of valve leaflets of the human body after implantation, has a certain limiting effect on the expansion of valve annulus tissues, and can reduce the obstruction of an outflow tract and promote the postoperative rehabilitation of a patient.

Description

Interventional artificial heart valve and medical device

Technical Field

The invention relates to the field of medical instruments, in particular to an interventional artificial heart valve and a medical device for improving the function of the heart valve.

Background

Heart valves are membranous structures that can be opened and closed inside the organs of humans or some animals. Each individual has four valves in the heart, namely an aortic valve that joins the left ventricle and the aorta, a pulmonary valve that joins the right ventricle and the pulmonary arteries, a mitral valve that joins the left atrium and left ventricle, and a tricuspid valve that joins the right atrium and right ventricle. They all act as one-way valves, allowing blood to flow only from one direction to the other, but not back. Mitral regurgitation can lead to myocardial remodeling, progressive enlargement of the ventricles, and ultimately heart failure. Transcatheter mitral valve replacement surgery (TMVR) has emerged in the prior art as a method of catheter intervention that compresses a prosthetic valve extracorporeally to a delivery system, delivers to the human mitral valve annulus, and releases the prosthetic valve for fixation at the mitral valve annulus to replace the native valve. Compared with the surgical operation, the TMVR does not need an extracorporeal circulation auxiliary device, has small wound and quick recovery of the patient, and can obviously improve the hemodynamics index of the postoperative patient.

However, how to effectively fix the mitral valve or the tricuspid valve in the heart and eliminate the blood regurgitation is a technical problem to be solved in the field of the intervention type artificial heart valve. Interventional prosthetic heart valves have been reported in which annular support elements bind the valve stent to the leaflets, and which are capable of better gripping the leaflet tissue after implantation and eliminating blood regurgitation, but the use of barbs, for example, can disrupt the normal physiological function of the body's leaflets after implantation.

There are anchoring structures in the art that do not employ barbs and that can reduce damage to leaflet tissue. However, the difficulty of accurately deploying the closed ring-shaped element of the interventional prosthetic heart valve to the back of the chordae tendineae and the valve leaflets is high, and the interventional prosthetic heart valve is difficult to stably fix after being implanted and has a high probability of causing perivalvular leakage of different degrees. In addition, the valve stent extends into the ventricular cavity, so that ventricular outflow tracts are blocked to a certain extent, complications such as arrhythmia, heart failure and the like are easily caused, and great adverse effects are caused to the rehabilitation process of patients who perform artificial valve replacement operations.

Disclosure of Invention

The invention discloses an intervention type artificial heart valve and a medical device, and aims to solve the technical problems in the prior art.

The invention adopts the following technical scheme: an interventional artificial heart valve comprises a valve bracket and an anchoring part,

the valve stent has a body section and a skirt section at an inflow end; a valve leaf part is arranged in the body section; the valve stent is radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration;

at least part of the outer surface of the skirt section is covered by a flexible annular sealing element, and the flexible annular sealing element comprises a material capable of absorbing blood; the blood-absorbing material expands after absorbing blood;

at least two connecting elements are arranged on one side of the outflow end of the body section;

the anchoring part is arranged around the periphery of the valve stent and is detachably connected with the connecting element; the anchor portion includes at least two anchors.

Preferably, the material capable of absorbing blood is one or a mixture of PET fibers, polyester fibers and polyamide fibers.

Preferably, the flexible annular seal further covers a partial region on the inflow end side of the body section.

As a preferred technical solution, the body section comprises a plurality of circumferentially arranged support portions; the support portion extends radially outward and toward the inflow end.

Preferably, the body section comprises a restraining portion disposed at a side edge of an inflow end of the body section for restraining intrusion of the flexible annular seal into an interior space of the valve stent.

Preferably, the anchor has a circular arc-shaped section, and the free end of the circular arc-shaped section has a connecting part.

Preferably, the arc-shaped section of the anchoring member and the connecting portion are both hollow pipes.

As a preferred technical solution, a first connecting element and a second connecting element are arranged at one side edge of the outflow end of the body section, the first connecting element is provided with a first connecting column and a second connecting column, and the second connecting element is provided with a third connecting column and a fourth connecting column;

the anchoring part comprises a first anchoring part and a second anchoring part, the connecting part of the first anchoring part comprises a first inserting port and a second inserting port, and the connecting part of the second anchoring part comprises a third inserting port and a fourth inserting port;

the first inserting port, the second inserting port, the third inserting port and the fourth inserting port can be respectively inserted into the first connecting column, the second connecting column, the third connecting column and the fourth connecting column.

As a preferred technical scheme, the first socket, the second socket, the third socket, and the fourth socket, and/or the first connecting column, the second connecting column, the third connecting column, and the fourth connecting column have anti-loose structures.

Preferably, the anti-loosening structure comprises one or more of a pawl, a ratchet wheel, a groove, a flange and a buckle.

According to a preferable technical scheme, the first connecting column, the second connecting column, the third connecting column and the fourth connecting column are all hollow columns.

Preferably, the support portion includes a first support portion band and a second support portion band arranged in a circumferential direction, and the first support portion band is closer to the inflow end side than the second support portion band.

The circular arc-shaped section is positioned in an area approximately enclosed by the first supporting part belt;

preferably, the first support strip and/or the second support strip each have a convergence near the first connecting element and the second connecting element, the support of the convergence converging radially with respect to the other supports of the first support strip and the second support strip.

The invention also provides a medical device for improving the function of the heart valve, which comprises a valve bracket and an anchoring part,

the valve stent has a body section and a skirt section at an inflow end; a valve leaf part is arranged in the body section; the valve stent is radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration; at least part of the outer surface of the skirt section is covered by a flexible annular sealing element, and the flexible annular sealing element comprises a material capable of absorbing blood; the blood-absorbing material expands after absorbing blood; at least two connecting elements are arranged on one side of the outflow end of the body section; the valve stent is placeable in a catheter in a radially collapsed state;

the anchoring part comprises at least two anchoring pieces, and each anchoring piece comprises an arc-shaped section and a connecting part at the free end of the arc-shaped section; the connecting part can be detachably connected with the connecting element; the anchoring part has elasticity and can be placed in the conduit after elastic deformation.

Preferably, the body section has a retraction area on a side thereof adjacent to the outflow end.

Preferably, an internal sealing membrane is arranged inside the valve support.

As a preferred technical solution, the skirt section is a trumpet-shaped structure, the body section is substantially cylindrical, and a small-diameter end of the trumpet-shaped structure of the skirt section is connected with the body section;

the outer peripheral edge of the trumpet structure has a downturned structure for increased anchoring with the native annulus.

Preferably, the cross section of the body section and/or the skirt section is a D-shaped or elliptical closed loop surrounded by a plurality of convex curves.

The technical scheme adopted by the invention can achieve the following beneficial effects:

on the basis of adopting the non-closed annular anchoring part, the valve stent structure and the connecting structure of the valve stent structure and the anchoring part are improved, the valve stent structure is suitable for being implanted into the left atrium or the right atrium of a heart of a human body through a catheter to replace a diseased mitral valve or tricuspid valve to perform functions, the normal physiological functions of valve leaflets of the human body cannot be damaged after the valve stent structure is implanted, a certain limiting effect is realized on the expansion of valve ring tissues, the obstruction of an outflow tract can be reduced, and the postoperative rehabilitation of a patient is promoted. Meanwhile, the flexible annular sealing element is made of a material capable of absorbing blood, absorbs the blood after the artificial heart valve is implanted, gradually expands, expands and thickens, fully fills gaps between the valve support and the skirt edge section as well as the human heart valve and the human valve ring, appropriately compresses human tissues, and avoids or reduces the occurrence of perivalvular leakage.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the description of the embodiments will be briefly introduced below to form a part of the present invention, and the exemplary embodiments and the description thereof illustrate the present invention and do not constitute a limitation of the present invention. In the drawings:

fig. 1 is a schematic structural diagram of a valve stent of an interventional prosthetic heart valve disclosed inembodiment 1 of the present invention;

fig. 2 is a schematic view of a combined structure of an interventional prosthetic heart valve disclosed inembodiment 1 of the present invention.

Fig. 3 is a schematic plan view of a valve holder of the interventional prosthetic heart valve disclosed in example 1 of the present invention;

fig. 4A is a schematic plan view of a valve holder of an interventional prosthetic heart valve disclosed in example 1 of the present invention;

fig. 4B is a schematic plan view of another embodiment of the valve holder of the interventional prosthetic heart valve disclosed in example 1 of the present invention;

FIG. 5 is a top view of a valve holder of the interventional prosthetic heart valve disclosed in example 1 of the present invention;

FIG. 6 is a schematic plan view of a valve holder of the interventional prosthetic heart valve disclosed in example 2 of the present invention;

fig. 7 is a schematic view of the state of the interventional prosthetic heart valve during implantation disclosed in embodiment 3 of the present invention;

fig. 8 is a schematic view of the heart implanted with the interventional artificial heart valve disclosed in embodiment 3 of the present invention.

Description of reference numerals:

aventricle 100; ahuman heart valve 200; ahuman valve annulus 300;cardiac chordae tendineae 400; an interventionalprosthetic heart valve 500;

avalve stent 1; abody section 10; asupport portion 11; afirst support belt 111; a secondsupport portion strap 112;convergence sections 1111 and 1121; arestraint portion 12; askirt section 120; a flip downstructure 121; alobe section 13; aretracted region 14; a flexible annular seal 15; a first connectingelement 16; the second connectingelement 17; a first connectingcolumn 161, a second connectingcolumn 162, a third connectingcolumn 171, and a fourth connectingcolumn 172;

ananchor part 2; afirst anchor 21; asecond anchor 22; afirst interface 211, asecond interface 212, athird interface 221, afourth interface 222; a circular arc-shapedsection 23; ananti-loosening structure 24; aguide wire 30.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the technical solutions of the present invention will be clearly and completely described below with reference to the specific embodiments of the present invention and the accompanying drawings. In the description of the present invention, it is noted that the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.

In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

As described herein, the "outflow tract" refers to the left ventricular outflow tract when the interventionalprosthetic heart valve 500 is a mitral valve, and the "outflow tract" refers to the right ventricular outflow tract when the interventionalprosthetic heart valve 500 is a tricuspid valve.

As used herein, "substantially enclosed" refers to an open space enclosed by open curved surfaces, rather than an enclosed space enclosed by a completely curved surface. "generally annular" may refer to a generally annular shape formed by a combination of multiple components, and is not limited to a closed annular shape, nor to a standard circular ring.

It is to be understood that the described embodiments are merely exemplary of the invention, and not restrictive of the full scope of the 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.

Example 1

The present example 1 provides an interventionalprosthetic heart valve 500, essentially comprising a substantiallycircumferential anchoring part 2 arranged in the vicinity of the native valve annulus tissue and avalve stent 1 provided with prosthetic valve leaflets.

According to fig. 1 and 3, the upper inflow end of thevalve holder 1 is provided with an atrial flange for engagement to thehuman annulus 300, in particular, thevalve holder 1 has abody section 10 and askirt section 120 at the inflow end; preferably,skirt section 120 is flared,body section 10 is substantially cylindrical, and the smallest diameter end of the flared configuration ofskirt section 120 joinsbody section 10. Preferably,body section 10 includes longitudinal and transverse backbones that are interconnected or interwoven, and in preferred embodiments, the transverse backbones can be replaced with other structures to provide better radial collapse performance while performing other functions, as discussed in detail below.

According to fig. 4A, alobe portion 13 is provided inside thebody section 10; thevalve portion 13 preferably has two or three artificial valve leaflets attached to struts of thevalve stent 1, and an inner sealing membrane is provided inside thevalve stent 1 to prevent paravalvular leakage.

The interventionalprosthetic heart valve 500 of this example 1 all requires transcatheter delivery, so thevalve stent 1 is radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration.

At least two connecting elements are arranged on one side of the outflow end of themain body section 10; the lower end of thevalve holder 1 is provided with a corresponding number of connections projecting radially outwards for receiving connection elements on the annular anchor.

According to fig. 2, the anchoringpart 2 is arranged around the circumference of thevalve stent 1 and is detachably connected with the connecting element; theanchor 2 comprises at least two anchors, i.e. theanchor 2 has at least two separate sections. The anchoring elements can substantially enclose a ring shape after the segments, in other words the anchoring elements, have been connected correspondingly to the connecting element. Those skilled in the art will understand that there is not completely no gap between the anchors, but a gap is allowed to exist, and the smaller gap does not affect the effect of thepresent embodiment 1, and does not cause the problem of backflow and the like. In practice, the ring-shapedanchor 2 is placed in theventricle 100, under thehuman valve annulus 300, on the periphery of thehuman heart valve 200, and the interference fit is formed between theanchor 2 and thevalve holder 1, so that the interventionalartificial heart valve 500 can be effectively maintained at the ideal implantation position. By dividing the loopedanchor 2 into multiple segments (anchors), placement of the looped anchors around thecardiac chordae tendineae 400 in an open configuration behind the leaflet tissue is facilitated.

At least part of the outer surface of theskirt section 120 is covered by a flexible annular seal 15, the flexible annular seal 15 comprising a material capable of absorbing blood; preferably, the flexible annular seal 15 also covers a partial region of the inflow end side of saidbody segment 10.

In example 1, the material capable of absorbing blood is one or a mixture of PET fibers, polyester fibers, and polyamide fibers. Because the flexible annular sealing member 15 is made of a material capable of absorbing blood, in the implementation process of an interventional operation, after the flexible annular sealing member 15 enters the human heart through a catheter, the flexible annular sealing member covers the partial region of thehuman heart valve 200 and the partial region of thehuman valve ring 300, and after the flexible annular sealing member is contacted with blood, the material capable of absorbing blood gradually absorbs the blood, and morphological changes such as expansion, thickening and the like occur within minutes to tens of minutes. That is, after the anchoringpart 2 is connected to thevalve holder 1, the flexible annular sealing member 15 gradually expands, swells and thickens to fully fill the gap between thevalve holder 1 and theskirt section 120 and thehuman heart valve 200 and thehuman valve annulus 300, and to give appropriate compression to human tissue, thereby avoiding or reducing the occurrence of perivalvular leakage. Moreover, since the clamping force is applied to the valve annulus and/or thehuman heart valve 200 via the flexible annular seal 15, the pressure is applied more uniformly, and further damage to human tissue by thevalve stent 1 is avoided or reduced.

In thisembodiment 1, the anchor andvalve stent 1 are preferably made of a shape memory alloy, preferably nitinol for example, for delivery through a catheter to thehuman heart valve 200 in a compressed configuration and expanded to a predetermined configuration after release from a sheath of the catheter. Preferably, the outer surface of the annular anchor is covered with a thin film made of PET, PTFE or polyurethane material, which reduces damage to the captured leaflet tissue while facilitating the endothelialization process.

According to fig. 3, preferably, thebody section 10 comprises a plurality of circumferentially arranged supports 11; thesupport portion 11 extends radially outward and toward the inflow end. Preferably, the supportingportion 11 is substantially in a herringbone structure, two bottom ends of the herringbone structure are respectively connected with the vertical skeleton of thebody section 10, and a top end of the herringbone structure is in a circular arc shape. Preferably, thebody section 10 is not provided with a transverse skeleton, but a plurality ofsupport portions 11 in the shape of a Chinese character 'ren' evenly distributed in the circumferential direction of thebody section 10 function as a part of the transverse skeleton, supporting the radial structure of thebody section 10. The angle between the plane of the main body of the support part 11 (i.e. the top and middle of the herringbone structure) and thebody section 10 at the connection position is 30-60 degrees, preferably 50 degrees. It will be appreciated that the plurality ofsupport portions 11 andskirt segments 120 together define to some extent an internal channel for receiving theanchor portion 2. Through the cooperation that sets upskirt section 120 and supportingpart 11, guarantee intervention formulaartificial heart valve 500's anchor stability, avoid taking place to a certain extent and shift after implanting.

Preferably, thesupport portion 11 includes afirst support band 111 and asecond support band 112 arranged in a circumferential direction, and thefirst support band 111 is closer to the inflow end side than thesecond support band 112. It is preferable that thefirst support band 111 and thesecond support band 112 have a structure of 6support portions 11, respectively. The secondsupport portion band 112, near the lower outflow end of thevalve stent 1, can function to some extent as a leaflet splint for folding and clamping the leaflet tissue. During the interventional procedure, the leaflet tissue is captured and held by thefirst support band 111 and thesecond support band 112, and by lifting the leaflet tissue upward near the outflow tract of theventricle 100, the effective outflow area near the outflow tract is increased, resulting in a reduction of the outflow tract obstruction.

As a preferred embodiment, according to fig. 4A, the secondsupport portion strip 112 has aconvergence 1121 at a position close to the first connectingelement 16 and the second connectingelement 17, in particular, onesupport portion 11 of the secondsupport portion strip 112 closest to the first connectingelement 16 and theother support portion 11 closest to the second connectingelement 17, respectively twoconvergence 1121. Thesupport portion 11 of the convergingportion 1121 is radially converged relative to theother support portions 11 of thesecond support band 112. Preferably, the convergingportion 1121 extends toward the inflow end direction, but does not extend radially outward.

As another preferred embodiment, according to fig. 4B, thefirst support strap 111 and thesecond support strap 112 have, at a position close to the first connectingelement 16 and the second connectingelement 17, aconvergence 1111, 1121, in particular, onesupport 11 of thefirst support strap 111 closest to the first connectingelement 16 and theother support 11 closest to the second connectingelement 17, twoconvergence 1111, respectively; the onesupport 11 of thesecond support strap 112 closest to the first connectingelement 16 and theother support 11 closest to the second connectingelement 17 are two convergingportions 1121 respectively. Thesupport portion 11 of the convergingportion 1121 is radially converged relative to theother support portions 11 of thesecond support band 112. Preferably, the convergingportion 1121 extends toward the inflow end direction, but does not extend radially outward. This embodiment can avoidanchor portion 2 andvalve support 1 to take place to interfere to the at utmost, avoidsanchor portion 2 to hook atvalve support 1's supportingpart 11 in the operation implementation process, has reduced the operation degree of difficulty.

On this basis, as a preferred embodiment, as shown in fig. 4B, the first connectingelement 16 and the second connectingelement 17 have a smaller extent of radial outward extension than the embodiment shown in fig. 4A, so that the anchoringportion 2 enhances the anchoring effect on thehuman heart valve 200.

As shown in fig. 3, since the flexible annular seal 15 expands after absorbing blood, the expanded portion may undesirably expand excessively in the area not covered by thevalve stent 1 and excessively invade the inside of thevalve stent 1 with the passage of time, resulting in stenosis of the inside of thevalve stent 1. Therefore, as a preferred solution, thebody segment 10 comprises arestriction portion 12, and therestriction portion 12 is disposed at an edge of an inflow end of thebody segment 10 for restricting invasion of the flexible annular seal 15 into the inner space of thevalve stent 1. The constrainingpart 12 includes a plurality of transverse constraining frames, the transverse constraining frames are substantially in a herringbone structure, two bottom ends of the structure are respectively connected with the top end of the inflow end of the vertical skeleton of thebody section 10, and the top end of the structure is an arc. The inverted v-shaped structure of the lateral restraint frame enables the collapsible performance of thevalve stent 1 to be optimized.

According to fig. 2, the anchor preferably has a circular arc-shapedsection 23, the free end of the circular arc-shapedsection 23 having a connection. The two free ends of each segment are provided with connecting elements for connection to thevalve holder 1.

Preferably, the arc-shapedsection 23 of the anchor and the connecting portion are both hollow tubes.

Preferably, the circular arc-shapedsection 23 has a larger diameter than the connecting portion to increase the contact area of the anchoring member with the human tissue, and reduce the risk of injury to the human tissue while increasing the anchoring stability.

Preferably, according to fig. 1-2, a first connectingelement 16 and a second connectingelement 17 are arranged at one side edge of the outflow end of thebody section 10, the first connectingelement 16 has a first connectingcolumn 161 and a second connectingcolumn 162, the second connectingelement 17 has a third connectingcolumn 171 and a fourth connectingcolumn 172; the anchoringpart 2 comprises afirst anchoring part 21 and asecond anchoring part 22, the connecting part of the first anchoringpart 21 comprises afirst interface 211 and asecond interface 212, and the connecting part of thesecond anchoring part 22 comprises athird interface 221 and afourth interface 222; thefirst connection column 161, thesecond connection column 162, thethird connection column 171 and thefourth connection column 172 can be inserted into thefirst insertion port 211, thesecond insertion port 212, thethird insertion port 221 and thefourth insertion port 222 respectively.

Further preferably, thefirst socket 211, thesecond socket 212, thethird socket 221, and thefourth socket 222, and/or the first connectingcolumn 161, the second connectingcolumn 162, the third connectingcolumn 171, and the fourth connectingcolumn 172 have ananti-loose structure 24.

Preferably, theanti-release structure 24 comprises a combination of one or more of a pawl, a ratchet, a groove, a flange, a catch to ensure stability of the connection. It will be appreciated by those skilled in the art that theanti-release structure 24 can be selected from any similaranti-release structure 24 known in the art, and is not limited by the present application. Preferably, the first connectingcolumn 161, the second connectingcolumn 162, the third connectingcolumn 171 and the fourth connectingcolumn 172 are hollow columns.

According to fig. 3, the outer peripheral edge of the trumpet structure of theskirt section 120 has a turned downstructure 121 for increasing the anchoring effect with the native annulus. The downward-turningstructure 121 can be matched with the anchoringpart 2 to form a clamping effect, and the anchoring stability is further improved. Specifically, the trumpet-shaped structure ofskirt section 120 includes 6 petal-shaped skeletons, each petal-shaped skeleton includes a first section extending outward and upward from the top ofbody section 10, and a second section extending outward and downward, and it should be understood that the turned-downstructure 121 corresponds to the above-described second section of the petal-shaped skeleton. Meanwhile, the petal-shaped framework gradually shrinks along with the outward extension. In this embodiment, "outer" means a direction outward from the center of the horn-like structure, "upper" means a direction toward the inflow end, and "lower" means a direction toward the outflow end.

In addition, as a preferred technical solution, the cross section of thebody section 10 and/or theskirt section 120 is a D-shaped or elliptical closed loop surrounded by a plurality of convex curves to better match the structure of thehuman valve annulus 300.

The interventionalartificial heart valve 500 of theembodiment 1 is adapted to be implanted into the left atrium or the right atrium of the heart of a human body through a catheter to replace a diseased mitral valve or tricuspid valve to perform a function, without damaging the normal physiological functions of the valve leaflets of the human body, and has a certain limiting effect on the expansion of valve annulus tissues, and simultaneously, the outflow tract obstruction can be reduced, and the postoperative rehabilitation of a patient is promoted, on the basis of adopting the non-closedannular anchoring part 2, the structure of thevalve stent 1 and the connecting mechanism of the anchoringpart 2 are improved.

Example 2

Unlike theembodiment 1, the interventionalprosthetic heart valve 500 of fig. 6 is provided in the example 2, in which thevalve support 1 is of an asymmetric design as a whole, and the portion of the outflow end of thebody segment 10 corresponding to the outflow tract of theventricle 100 is offset in a direction away from the outflow tract, i.e. the side of thebody segment 10 close to the outflow end has aretraction region 14, so as to further reduce the influence on the outflow tract. It will be appreciated by those skilled in the art that the retractedregion 14 is preferably positioned so as to avoid the positions of the first and second connectingelements 16 and 17. The retractedregion 14 is preferably positioned equidistant from the first andsecond coupling members 16, 17 to minimize the impact on the outflow tract.

Further, since thevalve stent 1 is designed asymmetrically as a whole, thefirst anchor 21 and thesecond anchor 22 should be configured differently accordingly, and the anchors (for example, the first anchor 21) on the side corresponding to theretraction region 14 have smaller sizes. Specifically, the arc-shapedsection 23 of thefirst anchor 21 is shorter than the arc-shapedsection 23 of thesecond anchor 22, and the shapes and sizes of thefirst insertion port 211, thesecond insertion port 212, thethird insertion port 221, and thefourth insertion port 222 may not be changed.

Example 3

In this example 3, the implantation process of the interventionalprosthetic heart valve 500 of examples 1 and 2 will be described with reference to fig. 7 to 8.

During implantation, a plurality ofguide wires 30 are first arranged under the tissue of thehuman valve annulus 300, thefirst anchor 21 and thesecond anchor 22 of theanchor part 2 are delivered to the implantation position along theguide wires 30 arranged in advance by using a first delivery device, and release is completed, and eachguide wire 30 respectively penetrates out of the connecting elements at both ends of thefirst anchor 21 and thesecond anchor 22.

Subsequently, theguide wire 30 is passed through the corresponding connection portions on thevalve stent 1, such as the first connection posts 161 of thefirst connection elements 16, the third connection posts 171 of thesecond connection elements 17, and the second connection posts 162 of thefirst connection elements 16, the fourth connection posts 172 of thesecond connection elements 17, and thevalve stent 1 in the compressed state is delivered into the heart using the second delivery device.

The connection between the connection elements and the corresponding connection portions on the loop anchor is completed by theguide wire 30, for example, thefirst connection socket 211, thesecond connection socket 212, thethird connection socket 221, and thefourth connection socket 222 are respectively inserted into thefirst connection column 161, thesecond connection column 162, thethird connection column 171, and thefourth connection column 172, and are tightly connected by theanti-loose structure 24.

Further, the implantation procedure is then completed by withdrawing the protective sheath covering the exterior of thevalve stent 1 so that thevalve stent 1 expands to capture the native leaflets and form a secure fit with the annular anchors.

After that, the flexible annular sealing member 15 covers the partial region of thehuman heart valve 200 and the partial region of the valve annulus, after contacting with blood, the material capable of absorbing blood gradually absorbs blood, and morphological changes such as expansion, expansion and thickening continue to occur within minutes to tens of minutes after the implantation process is completed, and finally the flexible annular sealing member 15 gradually expands, expands and thickens to fully fill the gap between thevalve support 1 and theskirt section 120 and thehuman heart valve 200 and thehuman valve annulus 300, and to apply appropriate compression to human tissues, thereby further avoiding or alleviating perivalvular leakage.

Example 4

This example 4 provides a medical device, which can be understood as a medical kit, for improving the function of a heart valve. The medical device or kit comprises mainly two parts, namely avalve stent 1 and ananchor part 2. Additionally, a catheter and/orguidewire 30 may be included in the device or kit.

Thevalve stent 1 has abody section 10 and askirt section 120 at the inflow end; avane part 13 is arranged in thebody section 10; thevalve stent 1 is radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration; at least part of the outer surface of theskirt section 120 is covered by a flexible annular seal 15, the flexible annular seal 15 comprising a material capable of absorbing blood; the blood-absorbing material expands after absorbing blood; at least two connecting elements are arranged on one side of the outflow end of themain body section 10; thevalve stent 1 can be placed in a catheter in a radially collapsed state;

the anchoringpart 2 comprises at least two anchoringpieces 21 and 22, and the anchoringpieces 21 and 22 comprise circular arc-shapedsections 23 and connecting parts of the free ends of the circular arc-shapedsections 23; the connecting part can be detachably connected with the connectingelements 16, 17; theanchor 2 has elasticity and can be placed in the catheter after elastic deformation.

In this medical device or medical kit, both thevalve stent 1 and theanchor 2 may be provided in a radially collapsed state, or in a radially expanded state, prior to the intervention procedure being performed.

The medical device or medical kit may include instructions for performing the implantation method and procedure described in example 3 above.

The specific structure of thevalve stent 1 and the anchoringpart 2 is described in all the features of theembodiment 1 and theembodiment 2 in the specification.

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

Claims (18)

1. An interventional artificial heart valve, which is characterized by comprising a valve bracket and an anchoring part,

the valve stent has a body section and a skirt section at an inflow end; a valve leaf part is arranged in the body section; the valve stent is radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration;

at least part of the outer surface of the skirt section is covered by a flexible annular sealing element, and the flexible annular sealing element comprises a material capable of absorbing blood; the blood-absorbing material expands after absorbing blood;

at least two connecting elements are arranged on one side of the outflow end of the body section;

the anchoring part is arranged around the periphery of the valve stent and is detachably connected with the connecting element; the anchor portion includes at least two anchors.

2. The interventional prosthetic heart valve of claim 1, wherein the material capable of absorbing blood is a blend of one or more of PET fibers, polyester fibers, polyamide fibers.

3. The interventional prosthetic heart valve of claim 1, wherein the flexible annular seal further covers a partial region on a side of the inflow end of the body section.

4. The interventional prosthetic heart valve of claim 1, wherein the body segment comprises a plurality of circumferentially disposed supports; the support portion extends radially outward and toward the inflow end.

5. The interventional prosthetic heart valve of claim 1, wherein the body segment includes a restraint disposed at a side edge of the inflow end of the body segment for restraining the flexible annular seal from intruding into the valve stent interior space.

6. The interventional prosthetic heart valve of claim 1, wherein the anchor has a circular arc shaped section with a connection at a free end thereof.

7. The interventional prosthetic heart valve of claim 6, wherein the rounded section of the anchor and the connecting portion are both hollow tubes.

8. The interventional prosthetic heart valve of claim 1, wherein a first connecting element having a first connecting post and a second connecting element having a third connecting post and a fourth connecting post are disposed at an outflow-end-side edge of the body segment;

the anchoring part comprises a first anchoring part and a second anchoring part, the connecting part of the first anchoring part comprises a first inserting port and a second inserting port, and the connecting part of the second anchoring part comprises a third inserting port and a fourth inserting port;

the first inserting port, the second inserting port, the third inserting port and the fourth inserting port can be respectively inserted into the first connecting column, the second connecting column, the third connecting column and the fourth connecting column.

9. The interventional prosthetic heart valve of claim 8, wherein the first, second, third, fourth interfaces and/or the first, second, third, fourth connection posts have an anti-loosening structure.

10. The interventional prosthetic heart valve of claim 9, wherein the anti-loosening structure comprises a combination of one or more of a pawl, a ratchet, a groove, a flange, a catch.

11. The interventional prosthetic heart valve of claim 8, wherein the first, second, third, and fourth connecting posts are hollow cylinders.

12. The interventional prosthetic heart valve of claim 4, wherein the support portion comprises a circumferential array of first and second support bands, the first support band being closer to the inflow end side than the second support band.

13. The interventional prosthetic heart valve of claim 12, wherein the first support band and/or the second support band each have a convergence near the first connection element and the second connection element, the convergence having a support that is relatively radially convergent compared to other supports of the first support band and the second support band.

14. A medical device for improving the function of a heart valve is characterized by comprising a valve bracket and an anchoring part,

the valve stent has a body section and a skirt section at an inflow end; a valve leaf part is arranged in the body section; the valve stent is radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration; at least part of the outer surface of the skirt section is covered by a flexible annular sealing element, and the flexible annular sealing element comprises a material capable of absorbing blood; the blood-absorbing material expands after absorbing blood; at least two connecting elements are arranged on one side of the outflow end of the body section; the valve stent is placeable in a catheter in a radially collapsed state;

the anchoring part comprises at least two anchoring pieces, and each anchoring piece comprises an arc-shaped section and a connecting part at the free end of the arc-shaped section; the connecting part can be detachably connected with the connecting element; the anchoring part has elasticity and can be placed in the conduit after elastic deformation.

15. The interventional prosthetic heart valve of any one of claims 1-13 or the medical device of claim 14, wherein the body segment has a retraction region on a side thereof proximal to the outflow end.

16. The interventional prosthetic heart valve of any one of claims 1-13 or the medical device of claim 14, wherein an inner sealing membrane is disposed inside the valve holder.

17. The interventional prosthetic heart valve of any one of claims 1-13 or the medical device of claim 14, wherein the skirt section is a flared structure, the body section is substantially cylindrical, and a small diameter end of the flared structure of the skirt section connects the body section;

the outer peripheral edge of the trumpet structure has a downturned structure for increased anchoring with the native annulus.

18. The interventional prosthetic heart valve of any one of claims 1-13 or the medical device of claim 14, wherein a cross-section of the body segment and/or the skirt segment is a D-shaped or elliptical closed loop enclosed by a plurality of convex curves.

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