CN109350309B

CN109350309B - Stent valve prosthesis and delivery system thereof

Info

Publication number: CN109350309B
Application number: CN201811462573.0A
Authority: CN
Inventors: 吕世文; 李毅斌
Original assignee: Jenscare Scientific Co Ltd
Current assignee: Jenscare Scientific Co Ltd
Priority date: 2018-12-03
Filing date: 2018-12-03
Publication date: 2021-07-20
Anticipated expiration: 2038-12-03
Also published as: WO2020114299A1; CN109350309A

Abstract

The application relates to a stent-valve prosthesis and a delivery system thereof, which comprises a stent, valve leaflets and a clamping piece, wherein the stent comprises a supporting section and a valve sewing section, the proximal end of the supporting section is connected with the distal end of the valve sewing section, the valve leaflets are connected to the valve sewing section, the supporting section is placed on a patient valve ring and abutted against atrial tissues after being released, the clamping piece comprises one or more side wings, one end of the clamping piece is fixedly connected to the outer surface of the valve sewing section, the clamping piece sequentially has three forms from compression to complete release, and the first form is that the side wings are compressed in a control device; the second form is that the side wing extends along the radial direction of the valve sewing section and passes through the valve leaflet boundary of adjacent tissues to reach between the valve leaflet and the heart wall; the third form is that the flank extends and pastes the surface that leans on the valve section of making up along valve section of making up circumference, and the release is finished back patient's tissue leaflet and close on the chordae tendineae and is held by the centre gripping between flank and valve section of making up, is favorable to improving valve support anchoring firmness, improves the operation success rate.

Description

Stent valve prosthesis and delivery system thereof

The technical field is as follows:

the invention belongs to the field of medical equipment, and particularly relates to a stent-valve prosthesis and a delivery system thereof.

Background art:

the mitral valve structure is an ensemble of the mitral annulus, anterior valve, posterior valve, chordae tendineae, papillary muscles, left atrium, and left ventricle. Wherein the anterior valve leaflet and the posterior valve leaflet are jointly divided and are respectively positioned at the anterior lateral part and the posterior middle part. Chordae tendineae from bilateral papillary muscles are inserted into the valve leaflets, and are divided into three groups according to the insertion position: the combined tendon, anterior leaflet tendon, posterior leaflet tendon. The commissural chordae are inserted into the valve commissural region as the name implies. The single tendon, usually emanating from the papillary muscle, bifurcates into the leaflet commissure. The anterior leaflet chords are inserted to the free edge of the anterior leaflet to provide the necessary support for the valve anterior leaflet. The posterior leaflet tendon is inserted into the free edge and base of the posterior leaflet at the same time.

Mitral valve disease is the most common valvular disease, primarily due to pathological changes in the valve itself or secondary changes caused by lesions in the left cardiac system. The statistics of 1994-2003 in the united states alone show that the number of mitral valve procedures has doubled over the past decade. The number of mitral valve replacements in 2003 is even more high than 65000, with some patients undergoing simultaneous coronary artery bypass grafts. Although the literature reports that mortality and complications following mitral valve replacement are more severe than mitral valve repair, mitral valve replacement is admittedly the only way to continue its life in some patients. After the technological development of recent years, compared with the traditional large trauma operations such as thoracotomy, distraction, extracorporeal circulation establishment and the like, the replacement operation through catheter intervention can reduce the operation difficulty, shorten the recovery time of a patient and relieve the pain of the patient, so the replacement operation through catheter intervention gradually becomes the mainstream operation of mitral valve replacement. The catheter-guided mitral valve replacement currently has the following problems to be solved: how the replacement device can be accurately positioned at the desired location; how firmly the carrier (typically the stent structure) of the prosthetic valve is anchored in the desired position; how the replacement device accommodates for variability in the anatomy of the annulus. The technical features of the different mitral valve replacement devices currently available in the art are listed below.

Patent CN103079498A describes a version of transcatheter mitral valve prosthesis, the anchor of which has an atrial skirt, an annular region and a ventricular skirt, said ventricular skirt further comprising a trigonal anchoring tab disposed on an anterior portion of said ventricular skirt, said trigonal anchoring tab being adapted to be anchored against a first fibrous trigone on a first side of an anterior leaflet of the mitral valve of a patient, such that the anterior leaflet and adjacent chordae tendineae are captured between said trigonal anchoring tab and an anterior surface of said anchor. The ventricular skirt further comprises a second trigonal anchoring tab disposed on an anterior portion of the ventricular skirt, the second trigonal anchoring tab adapted to anchor against a second fibrous trigone opposite the first fibrous trigone such that an anterior leaflet and adjacent chordae tendineae are captured between the second trigonal anchoring tab and an anterior surface of the anchor. The ventricular skirt further comprises a posterior ventricular anchoring tab disposed on a posterior portion of the ventricular skirt, and wherein the posterior ventricular anchoring tab is adapted to anchor to a posterior leaflet of a patient's mitral valve, thereby seating the posterior ventricular anchoring tab between the posterior leaflet and a ventricular wall of the patient's heart. According to the release profile of the patent, the ventricular skirt is radially expanded to displace the native mitral valve leaflets radially outward, clamping the leaflets and adjacent chordae tendineae while radially expanding. The problem with this design is that the release of the anchoring tab is irreversible, making it difficult to ensure that the leaflets and their chordae tendineae are gripped in one release; before the anchoring lug plate is released, the annular part is already partially opened to press the natural valve leaflet, and at the moment, valve leaflet function failure time that the natural valve leaflet fails and the artificial valve leaflet fails to work appears, so that the normal heart blood supply function of a patient is influenced; limited by the release position, the release shape and the chordae environment, the anchoring tabs can only wrap and clamp the leaflet from the area relatively free of chordae, and the clamping stability is not ideal.

US8449599 Edwards discloses a mitral valve replacement stent comprising at least one clamping member on the outer surface of the stent. The clearance between the clip and the outer surface of the stent serves to capture the leaflets when the stent is compressed in the sheath. As the stent is gradually released, the gripping members become less and less clear of the outer surface of the stent, thereby gripping the leaflets therein. The design has three points, firstly, the bracket and the clamping piece are integrally cut, the clamping capacity of the clamping piece is greatly influenced by the wall thickness of the pipe, the bracket is also influenced by the wall thickness, when the supporting force of the bracket is overlarge, the normal work of tissues near a mitral valve such as an aortic valve can be pressed, and a designer is difficult to pursue the clamping piece to have larger clamping force while balancing the supporting force of the bracket; secondly, the process of overturning and shaping the clamping piece is complex, and even if the shaping is successful, the fatigue resistance of the clamping piece is questionable; thirdly, the clamping piece can only carry out cladding clamping from the area of the valve leaflet relatively without the chordae tendineae, and the clamping stability is not ideal; fourthly, the same clamping piece can only clamp a single valve leaf, and the backflow between the valve leaves cannot be avoided.

Patent US20080033541 discloses a method of securing a mitral valve stent to the mitral valve annulus using a stent secured to the stent to impinge against a substantial portion of the left atrium, thereby achieving an anchoring effect. The problem with this design is that the prosthetic mitral valve is subject to large impact forces of up and down displacement during motion, and if the struts are not sufficiently rigid, they are difficult to anchor; however, if the struts are too rigid, atrial tissue is easily damaged.

Patent US20130053950 describes a mitral valve stent with tension units attached to the ventricular part of the stent, one end of the tension units being attached to the stent and the other end to the myocardium, said tension units being intended to reduce the stress due to ventricular contraction. The problem with this design is that unlike mitral valve repair devices, where the replacement stent is subjected to a large impact during systole, the tension unit alone cannot ensure that it is not flushed away from the valve annulus, which can cause the replacement stent to shift position, resulting in a large amount of regurgitation.

Patent US20140005778 discloses a method of fixing a mitral valve stent on the mitral annulus, which introduces a valve stent fixing device consisting of upper and lower clips connected by at least two bridging units. The valve stent fixing device can be arranged in a sheath, the mitral valve annulus is positioned between an upper clamping piece and a lower clamping piece after the valve stent is taken out of the sheath, and then the valve stent is conveyed and is expanded in the fixing device. The problem with this design is that the mitral valve configuration varies widely from patient to patient, making it difficult for suppliers to grip different patients with a limited specification of fixation devices; the size of the annulus tissue to which the valve is attached behind the mitral valve varies greatly during the beating phase of the heart, which also presents difficulties in this design.

Patent US20140142691 discloses a method for fixing a mitral valve stent, which is to arrange an auxiliary anchoring stent on the aorta, wherein the auxiliary anchoring stent is connected with the mitral valve stent for the purpose of fixing the mitral valve stent. The design is limited in that placing a secondary anchoring stent in the aorta increases the difficulty of the procedure and carries a risk of injury to the aorta. The connecting rods between the secondary anchoring stent and the mitral valve stent can affect the proper function of the aortic valve and its associated tissue. If the aortic valve stent and the mitral valve stent are placed at the same time, patients suitable for the operation are rare, and even if the patients exist, the operation difficulty is greatly improved. And the mutual connection has the risk of mutual influence, and once the placement position deviates, or the position of the bracket deviates in the subsequent heart movement, the life safety of the patient is directly influenced.

Current clinical results indicate that there is not an ideal mitral valve replacement device. The main reason is that the mitral valve annulus has a special physiological structure and a complex physiological environment under the annulus, so that accurate positioning and fixation of the product are very difficult. Likewise, tricuspid valve replacement devices face similar problems as mitral valve replacement devices. In summary, although the above-described techniques are respectively effective in valve repair, the existing products are more or less deficient in the design of the anchoring means. In the field of mitral or tricuspid replacement surgery, a need exists for a prosthesis with accurate positioning and secure anchoring.

The invention content is as follows:

the aim of the present invention is to improve and remedy the drawbacks of the prior art by proposing a stent-valve prosthesis that can effectively solve several problems. The clamping piece is arranged on the support and comprises a side wing, the side wing is provided with a root part parallel to the longitudinal axis of the support and can rotate around the root part, and the side wing displaces along the radial direction of the valve sewing section in the releasing process, passes through the junction of adjacent tissue valve leaflets of a patient to reach between the valve leaflets and a heart wall, then rotates around the root part and is attached to the outer surface of the valve sewing section. After the release is finished, the tissue valve leaflets and the adjacent chordae tendineae of the patient are clamped between the side wings and the valve sewing sections, so that the anchoring firmness of the valve stent is improved, and the success rate of the operation is greatly improved.

The purpose of the invention is realized by the following technical scheme:

a stent-valve prosthesis comprising a stent, leaflets and a clamping element, the stent comprising a support section and a sewn valve section, the proximal end of the support section being attached to the distal end of the sewn valve section, the leaflets being attached to the sewn valve section, the support section being released and placed against the annulus of a patient and against atrial tissue, the clamping element comprising one or more wings, one end of the clamping element being fixedly attached to the outer surface of the sewn valve section, the clamping element having three configurations in sequence from compressed to fully released, the first configuration being that the wings are compressed within a control device; the second form is that the side wings extend along the radial direction of the valve sewing section and penetrate through the valve leaflet boundary of adjacent tissues to reach between the valve leaflets and the heart wall; the third form is that the lateral wings extend along the circumferential direction of the valve sewing section and lean against the outer surface of the valve sewing section.

The purpose of the invention can be further realized by the following technical scheme:

preferably, the side wings have root portions, and the clamping pieces are fixedly connected to the outer surface of the valve sewing section through the root portions.

Preferably, the flanks are able to rotate about the root.

Preferably, the root portion is parallel to the longitudinal axis of the stent.

Preferably, the root is disposed on a distal portion of the sewn valve section.

Preferably, the root portion is fixed at a connection of the valve sewing section and the support section.

Preferably, the lateral wings are of arc structures, and are unfolded along the circumferential direction of the outer surface of the valve sewing section in a natural state. The tissue leaflets of the patient and adjacent chordae tendineae are clamped between the wings and the sewn valve section after the wings have been released.

Preferably, when the clip is released, the root is located at the interface of adjacent tissue leaflets at the target site. More preferably, when the clamping member is released, the root portion is located at the interface position of the anterior valve and the posterior valve of the patient's mitral valve, or the root portion is located at the interface position of the anterior valve and the septal valve of the patient's tricuspid valve, or the root portion is located at the interface position of the anterior valve and the posterior valve of the patient's tricuspid valve, or the root portion is located at the interface position of the posterior valve and the septal valve of the patient's tricuspid valve.

Preferably, the lateral wings are released before the valve sewing segment is released, so that the design has the advantage that the lateral wings are used for positioning, and meanwhile, the problem that the normal heart blood supply function of a patient is influenced due to the fact that the valve sewing segment is partially opened to press the natural valve leaflet so as to cause the failure of one natural valve leaflet and the failure of the function of the artificial valve leaflet is avoided.

Preferably, the clamping piece is a plurality of clamping pieces.

More preferably, when one and the same clip comprises an even number of flanks, the two side ends of the clip are arched, the flanks being symmetrically arranged, wherein each flank has a single or multiple consecutive arched configuration. The advantage of this design is that the use of curved ends avoids puncturing the heart wall tissue and causing bleeding. More preferably, the clamping piece is provided with a convex point to facilitate sheathing.

More preferably, when the same clamping member includes two wings, the wings on both sides of the root of the clamping member are connected in a free state to form a closed loop structure. More preferably, the flanks located on both sides of the root of the clamping piece are mutually connected in a free state by clamping, welding, sewing and the like, or the flanks located on both sides of the root of the clamping piece are of an integrated structure wound by shape memory alloy wires, or the flanks located on both sides of the root of the clamping piece are integrally cut by a shape memory alloy tube.

More preferably, when the same clamping member includes two flanks, the flanks on both sides of the root of the clamping member are in an open loop configuration in a free state. The advantage of this design is to avoid the side wings on both sides entering the sheath at the same time, which results in an increase in the size of the sheath.

Preferably, when the same clamping piece only comprises a single side wing, the side wing has a single or a plurality of continuous arc-shaped configurations, one side end part of the clamping piece is arc-shaped, and the lengths of the side wings in different clamping pieces which are unfolded along the outer surface of the valve sewing section in a free state are unequal.

Preferably, the root is fixedly connected to the valve sewing section by gluing, welding, winding, clamping and the like.

More preferably, a hole is provided on the distal portion of the valve sewing section, and the root is passed around the hole.

More preferably, a notch is provided on the distal portion of the sewn valve section, the heel riding over the notch and being looped through the hole.

More preferably, a notch is provided on the distal end portion of the valve sewing section, and the root portion straddles the notch and is fitted over the outer surface of the notch. More preferably, the outer surface of the jacket is provided with slits, the width of which is adapted to the diameter of the root.

Preferably, the clamping piece is formed by winding a shape memory alloy wire, or the clamping piece is formed by cutting and shaping a shape memory alloy pipe.

Preferably, the diameter of the support section is larger than that of the valve sewing section, the support section is flared outwards along the axis of the support section to form an inverted cone, and the cone angle is 60-160 degrees. More preferably, the taper angle is 135 °.

Preferably, the outer surface of the valve sewing section is partially covered with a film, or the outer surface of the support section is partially covered with a film, or both the outer surface and the outer surface of the support section are partially covered with a film, and the film is made of polytetrafluoroethylene, polyethylene, polypropylene, polyurethane, silica gel and the like, so that perivalvular leakage is effectively prevented.

Preferably, the leaflet is made of animal tissue or a high molecular polymer. More preferably, the animal tissue is porcine pericardium, bovine pericardium, equine pericardium, etc., and the high molecular polymer is polytetrafluoroethylene, polyurethane, silica gel.

Preferably, the stent is a self-expanding stent made of shape memory materials or elastic materials, preferably nickel-titanium shape memory alloys. More preferably, the stent is integrally carved by a shape memory material tube, preferably a nickel titanium shape memory alloy tube.

The purpose of the invention is also realized by the following technical scheme:

a delivery system for a stent-valve prosthesis, the delivery system comprising a stent-valve prosthesis, an outer sheath, a stent sheath core, and a holder sheath, the stent-valve prosthesis comprising a stent, valve leaflets, and a holder, the stent comprising a support section and a sewn-valve section, the stent sheath and the holder sheath being disposed within the outer sheath, the holder sheath being disposed outside the stent sheath, the sewn-valve section being compressed and disposed within a distal portion of the stent sheath, the support section being compressed and disposed within a distal portion of the outer sheath, a proximal end of the sewn-valve section being coupled to a distal end of the stent sheath core, the stent sheath core being disposed within the stent sheath, the holder being compressed and disposed within a distal portion of the holder sheath, a proximal end of the outer sheath being fixedly coupled to an outer sheath operator, a proximal end of the stent sheath being fixedly coupled to a stent operator, the proximal end of the bracket sheath core is fixedly connected to the bracket sheath core operating part, and the proximal end of the clamping piece sheath is fixedly connected to the clamping piece sheath operating part.

More preferably, the clip sheath is non-circular in cross-section.

More preferably, a clamping piece sheath core is further arranged in the clamping piece sheath, the distal end of the clamping piece sheath and the distal end of the clamping piece sheath core are both flexible, the distal end of the clamping piece sheath core is in contact with the clamping piece, and the proximal end of the clamping piece sheath core is fixedly connected to the clamping piece sheath core operating piece.

More preferably, when the clip needs to be compressed into the clip sheath, the clip is straightened and compressed within the clip sheath in a direction opposite the deployment direction.

More preferably, the delivery system further comprises a clamp guide wire, the clamp guide wire is located in the clamp sheath core, the wing is compressed along the root portion in a direction opposite to the expansion direction to form a gap, when the clamp is in the first configuration, the distal end of the clamp guide wire passes through the gap, and the proximal end of the clamp guide wire is fixedly connected to the clamp guide wire operating member.

More preferably, the distal end portion of the clip sheath is provided with a slit.

More preferably, rotating said clip sheath operator causes said clip sheath with said shoulder located therein to rotate about said root.

Compared with the prior art, the invention has the advantages that:

1. different from the mode of clamping the valve leaflets (only axial clamping can be carried out from the regions of the valve leaflets relatively without the chordae tendineae), the side wings on the clamping pieces are unfolded along the circumferential direction of the outer surface of the valve sewing section in a natural state, the purpose that one clamping piece simultaneously clamps adjacent valve leaflet tissues and chordae tendineae is achieved, the anchoring effect is improved, and meanwhile the regurgitation between the adjacent valve leaflet tissues is effectively reduced.

2. The invention is characterized in that the side wing penetrates from the juncture of adjacent tissue valve leaflets of a patient to the space between the valve leaflets and the heart wall and rotates around the root in the releasing process, the release from the position can avoid influencing the movement of the original mitral valve leaflets, maintain the normal blood supply of the heart, ensure more sufficient positioning time, facilitate the position adjustment of a doctor and improve the positioning accuracy.

3. The side wing is released before the valve sewing section is released, so that the design has the advantage that the positioning is carried out through the side wing, and meanwhile, the problem that the normal heart blood supply function of a patient is influenced due to the fact that one natural valve leaflet fails and the artificial valve leaflet fails to work due to the fact that the valve sewing section is partially opened to press the natural valve leaflet is avoided.

4. The valve sewing section is connected with the valve sewing section after being separately designed and processed, the side wings can rotate around the root parts, the side wings can conveniently realize the function of clamping valve leaflets and adjacent chordae tendineae, and a designer can pursue the clamping piece to have larger clamping force while balancing the support force of the support; and the shaping process of the clamping piece is relatively simple, and the fatigue performance is good.

5. The side wing is of an arc-shaped structure, the design of the arc-shaped structure enables the side wing to be attached to the outer surface of the valve sewing section, the side wing can clamp valve leaflets and chordae tendineae simultaneously, and meanwhile the clamping effect is enhanced when the side wing is inserted into a chordae tendineae gap.

6. The root part is fixed at the connecting part of the valve sewing section and the supporting section, so that the root part can be closer to the junction of adjacent tissue valve leaflets of a patient in the releasing process, and the side wings can conveniently penetrate from the junction of the adjacent tissue valve leaflets of the patient to the position between the valve leaflets and the heart wall; meanwhile, the far end of the side wing can abut against the valve ring position of a patient, and the supporting section is matched with the valve ring of the patient to clamp the valve ring of the patient, so that the clamping effect is enhanced.

7. The distal end of the clip sheath and the distal end of the clip sheath core of the present invention are both flexible in order to allow the clip sheath and clip sheath core to conform to the deformation of the clip. When the clamping piece is partially exposed out of the clamping piece sheath, the clamping piece sheath and the clamping piece sheath core are integrally pushed so that the exposed part of the clamping piece is arched towards the direction of the ventricular wall, and the side wing penetrates from the junction of adjacent tissue valve leaflets of a patient to reach between the valve leaflets and the ventricular wall; meanwhile, the process is reversible, the exposed part of the clamping piece can be restored to a non-arched state by integrally pulling the clamping piece sheath and the clamping piece sheath core, so that a doctor can adjust and position for many times, and the positioning accuracy is improved.

8. In the invention, the clamping member guide wire is positioned in the clamping member sheath core, the side wing is compressed along the root part in the direction opposite to the unfolding direction to form a gap, and the distal end of the clamping member guide wire penetrates through the gap, so that the design can ensure that the side wing can be completely opened when the clamping member guide wire is pulled out of the gap, prevent the side wing from being unfolded along the outer surface of the valve sewing section prematurely when being released from the clamping member sheath, and ensure that the tissue valve leaflet and adjacent chordae tendineae of a patient are clamped between the side wing and the valve sewing section after the release is finished.

Drawings

Fig. 1a and 1b show a schematic representation of a mitral valve structure, and fig. 1c and 1d show a prior art schematic representation of a mitral valve holder.

Fig. 2a to 2d show schematic views of an embodiment of the stent-valve prosthesis of the present invention.

Fig. 3a and 3b show schematic views of another embodiment of the stent-valve prosthesis of the present invention.

Fig. 4a to 4f show schematic views of various embodiments of the clamp of the present invention.

Fig. 5 a-5 d show schematic views of various embodiments of the stent-valve prosthesis of the present invention.

Fig. 6a to 6h show schematic views of various connection modes between the clamping piece and the valve sewing segment of the invention.

Fig. 7a to 7f show schematic views of various embodiments of the clamp of the present invention.

Fig. 8a-8e show schematic views of one embodiment of a delivery system for a stent-valve prosthesis of the present invention.

Fig. 9a-9e show schematic views of another embodiment of a delivery system for a stent-valve prosthesis of the present invention.

Fig. 10a to 15c show a procedure for achieving fixation of the stent-valve prosthesis of the present invention step by step.

Fig. 16a and 16b show schematic views of another embodiment of a stent-valve prosthesis of the present invention.

Fig. 17a-17 d illustrate a schematic view of another embodiment of a delivery system for a stent-valve prosthesis of the present invention.

Fig. 18a to 23c show step by step another procedure for achieving fixation of the stent-valve prosthesis of the present invention.

Fig. 24a and 24b show schematic views of the tricuspid valve structure, and fig. 24c and 24d show schematic views of an embodiment of the present invention when applied in the field of tricuspid valves.

The specific implementation mode is as follows:

in order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail below with reference to the accompanying drawings and examples.

The distal end of the present invention refers to the end away from the apex of the heart, and the proximal end refers to the end near the apex of the heart.

The first embodiment is as follows:

mitral valve structure 010 as shown in fig. 1a and 1b, mitral valve structure 010 is an integral body composed of mitral annulus 011, anterior valve 012, posterior valve 013, chordae tendineae 014, papillary muscles 015, left atrium 016, and left ventricle 017. Wherein the anterior leaflet 012(a1, a2, A3) and the posterior leaflet 013(P1, P2, P3) are divided jointly and respectively located in the antero-lateral part and the posterior central part. As shown in fig. 1c and 1d, the FORTIS of Edwards and TIARA of Neovasc, which are prior art products, approach the valve leaflet from the free position to the valve annulus by using an anchoring tab structure 018 fixed on the stent, and then clamp the valve leaflet from the position shown in fig. 1d (the stent body is omitted from the drawing), so that the process of inserting the anchoring tab 018 into the base of the valve leaflet and the clamping result both basically avoid the chordae tendineae (the anchoring tab 018 is roughly located in the areas a2 and P2), the clamping effect is very limited, and the anchoring is not firm and reliable.

As shown in fig. 2a-2c, in order to improve the positioning and anchoring effect, the present invention provides a stent-valve prosthesis 100, which comprises a stent 110, valve leaflets (not shown) and clamping members 130, wherein the stent 110 comprises a support section 111 and a valve sewing section 112, the proximal end of the support section 111 is connected with the distal end of the valve sewing section 112, the valve leaflets are connected with the valve sewing section 112, the support section 111 is placed above the valve annulus of a patient and is abutted against atrial tissue after being released, and the stent-valve prosthesis 100 comprises two clamping members 130. Each of the clamping members 130 comprises a single wing or two wings 131, the wings 131 are provided with root portions 132 parallel to the longitudinal axis of the bracket 110 and can rotate around the root portions 132, one end of each clamping member 130 is fixedly connected to the outer surface of the distal end part of the valve sewing section 112 through the root portions 132, and the clamping members 130 sequentially have three forms from compression to complete release, wherein the first form is that the wings 131 are compressed in a control device; the second configuration is that the lateral wings 131 extend along the radial direction of the valve sewing section 112, and penetrate through the boundary of adjacent tissue valve leaflets of a patient to reach between the valve leaflets and the heart wall; the third configuration is that the lateral wings 131 extend along the circumferential direction of the valve sewing section 112 and abut against the outer surface of the valve sewing section 112. During release, the lateral wings 131 are displaced in the radial direction of the valve sewing segment, pass through the junction of adjacent tissue leaflets of a patient to reach between the leaflets and the heart wall, and then rotate around the root portions 132, stretch circumferentially along the valve sewing segment 112 and abut against the outer surface of the valve sewing segment 112. In the present invention, the junctions of the adjacent tissue leaflets refer to the junctions between the anterior mitral valve and the posterior mitral valve (the junction of the mitral valve in the physiological anatomy), the junctions between the anterior tricuspid valve and the posterior tricuspid valve, the junctions between the anterior tricuspid valve and the septal tricuspid valve, and the junctions between the posterior tricuspid valve and the septal tricuspid valve.

The valve leaflet is made of animal tissue or high molecular polymer. More preferably, the animal tissue is porcine pericardium, bovine pericardium, equine pericardium, etc., and the high molecular polymer is polytetrafluoroethylene, polyurethane, silica gel. The stent 110 is a self-expandable stent made of shape memory material or elastic material, preferably nickel titanium shape memory alloy. More preferably, the stent 220 is integrally carved from a shape memory material tube, preferably a nickel titanium shape memory alloy tube.

As shown in fig. 2c, the side wings 131 are arc-shaped structures, the side wings 131 are unfolded along the outer surface of the valve sewing segment in a natural state, and the tissue leaflets and adjacent chordae tendineae of the patient after the side wings 131 are released are clamped between the side wings 131 and the valve sewing segment 112. The arc structure is designed to enable the side wing 131 to cling to the outer surface of the valve sewing segment 112, and the side wing 131 can simultaneously clamp the valve leaflets and the chordae tendineae, and the clamping effect is also enhanced by the insertion of the side wing 131 in the chordae gap. Different from the existing integrated cutting design of the clamping piece and the valve stent, the clamping piece 130 and the valve sewing section 112 are separately designed and connected together after being processed, the side wing 131 can rotate around the root part 132, the function of clamping the valve leaflet and the adjacent chordae tendineae of the valve leaflet can be realized conveniently by the side wing 131, and a designer can pursue the clamping piece 130 to have larger clamping force while balancing the support force of the stent; and the shaping process of the clamping piece 130 is relatively simple, and the fatigue performance is good. As shown in fig. 2d, unlike the conventional way (fig. 1c and 1d) of clamping the leaflets (only axial clamping can be performed from the regions of the leaflets relatively without chordae tendineae), the clamping members 130 of the present invention can be circumferentially spread along the outer surface of the valve sewing section 112, so as to achieve the purpose of simultaneously clamping adjacent leaflet tissues and chordae tendineae by one clamping member, thereby improving the anchoring effect and effectively reducing regurgitation between the adjacent leaflet tissues. In the releasing process, the side wings 131 penetrate through the junction (black solid rectangle in the figure) of the adjacent tissue valve leaflets of the patient, reach between the valve leaflets and the heart wall and rotate around the root, so that the motion of the original valve leaflets of the mitral valve can be prevented from being influenced, the normal blood supply of the heart is maintained, the positioning time is more sufficient, the position adjustment of a doctor is facilitated, and the positioning accuracy is improved.

As shown in fig. 2a and 2b, the root 132 is fixedly connected to the joint (boundary) of the sewing segment 112 and the support segment 111 by gluing, welding, looping, clamping, etc., and when the clamping member 130 is released, the root 132 is located at the boundary of the adjacent tissue leaflets at the target affected part. As shown in fig. 3a and 3B, preferably, when the clamp 130 is released, the root 132 (locations 132a and 132B in fig. 3B) is located at the anterior-posterior valve interface (locations a and B in fig. 3 a) of the patient's mitral valve. Such a design allows the side wings 131 to be closer to the patient's adjacent tissue leaflet interfaces during release, facilitating the passage of the side wings 131 from the patient's adjacent tissue leaflet interfaces to between the leaflets and the heart wall; meanwhile, the far ends of the lateral wings 131 can abut against the valve ring of the patient, and are matched with the supporting sections 111 to clamp the valve ring of the patient, so that the clamping effect is enhanced.

As shown in fig. 4a-4f, in one embodiment, the clamping member 130 includes two side wings 131, and the side wings 131 are symmetrically disposed, such that when the clamping member 130 is released after being compressed in the sheath, the side wings 131 can be symmetrically released, which facilitates the effect of clamping and anchoring. The clamping member 130 has an arc-shaped end portion at both sides, so that the arc-shaped end portion can prevent the heart wall tissue from being punctured to cause bleeding. The wings 131 have a single or multiple continuous arcuate configuration to provide a larger gripping area and enhance the gripping effect. The side wings 131 on both sides of the clamping member 130 are connected in a free state to form a closed loop structure, and the connecting means includes clamping, welding, sewing and binding. In another preferred embodiment, the side wings 131 on both sides of the root of the clamping member 130 are made of a shape memory alloy wire wound integrally. As a preferred embodiment, as shown in fig. 4f, the clip 130 is provided with a protrusion 133 to facilitate sheathing.

In one embodiment, as shown in fig. 5a, the diameter of the support section 111 is larger than the diameter of the valve sewing section 112, and the support section 111 is flared outward along its axis into a reverse taper with a taper angle of 60-160 °. Preferably, the taper angle is 135 °. Such a design can serve as an automatic positioning and support, i.e. the support section 111 automatically presses against the native heart valve annulus to assume the function of automatic positioning when the valved replacement stent is released at the implantation site, and can provide support after the replacement stent is released, preventing the replacement stent from falling out into the ventricle. As shown in fig. 5b-d, as a preferred embodiment, the outer surface of the support section 111 is partially covered with a film 140, or the outer surface of the valve sewing section 112 is partially covered with a film 140, or both are partially covered with a film 140, and the material of the film 140 includes teflon, polyethylene, polypropylene, polyurethane, silicone, etc. to effectively prevent paravalvular leakage.

In one embodiment, as shown in fig. 6a-d, a hole 1120 is provided in the distal portion of the sewn valve section 112, and the root 132 is threaded through the hole 1120. FIG. 6a is a double hole, the diameter of the hole 1120 being slightly larger than the diameter of the root 132; as shown in fig. 6b, four holes are arranged side by side up and down, left and right, on the distal end portion of the valve sewing section 112, so as to improve the connection strength between the root portion 132 and the valve sewing section 112, and prevent the root portion 132 from rotating in the hole 1120; as shown in fig. 6c, four holes are provided on the distal end portion of the sewing segment 112, which are arranged side by side, but offset from each other, and this is also designed to prevent the root 132 from rotating in the hole 1120; as shown in fig. 6d, two upper and lower non-circular holes 1121 are formed on the distal end portion of the valve sewing section 112, and two nitinol wires of the root portion 132 are wound through the non-circular holes 1121. As shown in fig. 6e, a non-circular hole 1121 and two circular holes 1120 are formed on the distal end portion of the valve sewing section 112, and two nitinol wires constituting the root portion 132 are wound through the non-circular hole 1121 and the circular holes 1120, respectively. In another embodiment, as shown in fig. 6f, a notch 1122 is provided on the distal portion of the valve sewing segment 112, and the root 132 straddles the notch 1122 and is sleeved with a metal jacket 1123 on the outer surface of the notch 1122. This design enables the root 132 to be firmly attached to the distal portion of the sewing valve segment 112, and can withstand the torque caused by the rotation of the wings around the root 132. As shown in fig. 6g, the outer surface of the metal jacket 1123 is provided with slits 1124 having a width adapted to the diameter of the roots 132, such design can prevent the roots 132 from slipping out of the gaps 1122. As another preferred embodiment, as shown in FIG. 6h, a notch 1122 is provided on the distal portion of the sewing segment 112, and the root 132 rides in the notch 1122 and is threaded around the hole 1121.

As shown in fig. 7a and 7b, in one embodiment, when the same clip 130 includes only a single wing 131, the wing 131 has a single or multiple continuous arc configuration, and one side end of the clip 130 is arc-shaped. As shown in fig. 7c, the wings (131a and 131b) in the different clips 130 have unequal spreading lengths along the outer surface of the valve sewing segment in the free state (L1 ≠ L2). The design enables the clamping width of different side wings to be adjusted along with the clamped valve leaflets, for example, the axial expansion length of the mitral valve posterior valve is longer than that of the mitral valve anterior valve, so that the side wings for clamping the posterior valve are longer than the side wings for clamping the anterior valve, the clamping area can be increased, and the clamping effect is enhanced. As another embodiment, shown in fig. 7d-f, the

clamps

130a and 130b each include a

wing

131a and 131b, the

roots

132a and 132b are fixed at the junction of the sewing segment and the support segment, and when the

clamps

130a and 130b are released, the

roots

132a and 132b are located at the interface of adjacent tissue leaflets at the target site. Preferably, when the

clamps

130a and 130b are released, the

roots

132a and 132b are positioned at the anterior-posterior valve interface of the patient's mitral valve. Such a design enables independent control of the loading and release of the

wings

131a and 131 b.

As shown in fig. 8a-8e, to achieve the above technical solution, the present invention further provides a delivery system 160 of a stent-valve prosthesis, the delivery system comprises a stent-valve prosthesis, an outer sheath 161, a stent sheath 162, a stent sheath core 163 and a holder sheath 164, the stent-valve prosthesis comprises a stent, valve leaflets (not shown) and holders 130, the stent comprises a support section 111 and a sewing section 112, the stent sheath 162 and the holder sheath 164 are located in the outer sheath 161, the holder sheath 164 is located outside the stent sheath 162, the sewing section 112 is located in a distal end portion of the stent sheath 162 after being compressed, the support section 111 is located in a distal end portion of the outer sheath 161 after being compressed, a proximal end of the sewing section 112 is connected to a distal end of the stent sheath core 163, the stent core 163 is located in the stent sheath 162, the clamp 130 is compressed and positioned within the distal portion of the clamp sheath 164, the proximal end of the outer sheath 161 is fixedly attached to the outer sheath operator 1610, the proximal end of the stent sheath 162 is fixedly attached to the stent sheath operator 1620, the proximal end of the stent sheath core 163 is fixedly attached to the stent sheath operator 1630, and the proximal end of the clamp sheath 164 is fixedly attached to the clamp sheath operator 1640.

The clamp 130 has three configurations in sequence from compression to complete release, the first configuration is that the clamp 130 is compressed in the clamp sheath 164, the second configuration is that the side wing 131 of the clamp 130 is displaced along the radial direction of the valve sewing section 112, passes through the junction of adjacent tissue leaflets of a patient, and reaches between the leaflets and the heart wall, and the third configuration is that the side wing 131 rotates around the root 132 and abuts against the outer surface of the valve sewing section 112.

To ensure that clip 130 is released from clip sheath 164, in a preferred embodiment, a clip sheath core 165 is further disposed within clip sheath 164, a distal end of clip sheath core 165 is in contact with clip 130, and a proximal end of clip sheath core 165 is fixedly attached to clip sheath core manipulator 1650. The distal ends of the clip sheath 164 and clip sheath core 165 of the present invention are flexible in order to allow the clip sheath 164 and clip sheath core 165 to conform to the deformation of the clip 130. When the clip 130 partially exposes the clip sheath 164, pushing the clip sheath 164 and the clip sheath core 165 together causes the exposed portion of the clip 130 to arch toward the ventricular wall, the side wings 131 passing from the patient's adjacent tissue leaflet interface to between the leaflets and the ventricular wall; the process is reversible, and the exposed part of the clamping piece 130 can be restored to a non-arched state by integrally pulling the clamping piece sheath 164 and the clamping piece sheath core 165, so that a doctor can adjust and position for multiple times, and the positioning effect is improved. As a preferred embodiment, when the clip 130 needs to be compressed into the clip sheath 164, the wings 131 are compressed along the roots 132 in a direction opposite to the deployment direction and then straightened into the clip sheath 164. Different from the common straightening and sheathing treatment, the design enables the side wings 131 to be unfolded into an arc-shaped structure along the circumferential direction of the valve sewing section 112 when being completely exposed out of the clamping piece sheath 164, so that the clamping force is improved.

As shown in fig. 9a-9e, in one embodiment, the cross-section of the clamp sheath 164 is non-circular, which allows for space utilization and a reduction in sheath size as compared to a circular cross-section. As another preferred embodiment, the delivery system 160 of the present invention further includes a clip guide wire 166, wherein the clip guide wire 166 is positioned within the clip sheath core 165, and wherein the proximal end of the clip guide wire 166 is fixedly attached to the clip guide wire actuator 1660. The wings 131 are compressed along the roots 132 in a direction opposite to the deployment direction to form a gap 1310, and when the clip 130 is in the first configuration, the distal ends of the clip guide wires 166 pass through the gap 1310, which ensures that the wings 131 are fully opened when the clip guide wires 166 are withdrawn from the gap 1310, prevents the wings 131 from prematurely deploying along the circumference of the sewing segment 112 when released from the clip sheath 164, and ensures that the tissue leaflets and adjacent chordae tendineae of the patient are clamped between the wings 131 and the sewing segment 112 after release.

The operation of the delivery system 160 for a stent-valve prosthesis according to the present invention will be described step by step as follows:

(1) as shown in fig. 10a-10c, a delivery system 160 of the stent-valve prosthesis is provided, the delivery system comprising a stent-valve prosthesis, an outer sheath 161, a stent sheath 162, a stent sheath core 163 and a clamp sheath 164, the stent-valve prosthesis 100 comprising a stent, valve leaflets (not shown) and clamps, the stent comprising a support section 111 and a sewing segment 112, each clamp comprising a single or two wings 131, the wings 131 having roots 132 parallel to the longitudinal axis of the stent 110, the wings 131 being rotatable around the roots 132, the clamps being fixedly attached to the outer surface of the distal portion of the sewing segment 112 by the roots 132.

The wings 131 of the clip are pre-assembled in the clip sheath 164 after being compressed along the root 132 in a direction opposite to the direction of deployment, in a first configuration (meaning a state in which the clip is compressed in the lumen), and the distal ends of the clip guide wires 166 pass through the slits 1310 formed by the compression of the wings 131; retracting the sewn valve section 112 into the stent sheath 162 after compression; the compressed spreader section 111, the grip sheath 164, and the stent sheath 162 are then received within the outer sheath 161. The distal end of the outer sheath 161 is transapically accessed to the patient's mitral valve.

(2) 11a-11c, the stent-valve prosthesis is delivered to the target site of the patient, and the outer sheath operator 1610 is manipulated to cause the outer sheath 161 to slide axially proximally until the deployment section 111 is released for deployment; the position of the spreader section 111 is adjusted to be placed over the patient's annulus and against the atrial tissue.

(3) 12a-12c, operating the clip sheath operator 1640 slides the clip sheath 164 axially proximally until the clip is released halfway, at which time the wings 131 fail to fully deploy due to the constraint of the clip guide wire 166; the position of the root 132 is adjusted such that the root 132 is proximate to the patient's adjacent tissue leaflet interface.

(4) As shown in fig. 13a-13c, pushing the clamp sheath operator 1640, the clamp sheath core operator 1650, and the clamp guide wire operator 1660 in unison causes the clamp 130 to transition from the first configuration to a second configuration within the heart (meaning that the clamp 130 arches in a radial direction along the sewing segment of the valve, across the patient's adjacent tissue leaflet interface, between the leaflets and the heart wall); meanwhile, the process is reversible, the exposed part of the clamping piece 130 can be restored to a non-arched state by integrally pulling the clamping piece sheath operating piece 1640, the clamping piece sheath core operating piece 1650 and the clamping piece guide wire operating piece 1660, and a doctor can adjust positioning for multiple times, so that the positioning accuracy is improved. The side wing 131 is released before the valve sewing section 112 is released, so that the design has the advantage that the positioning by the side wing 131 avoids that the valve sewing section 112 is partially opened to press the natural valve leaflet, so that the valve leaflet function failure time when the natural valve leaflet fails and the artificial valve leaflet fails to work is avoided, and the normal heart blood supply function of a patient is influenced.

(5) 14a-14c, the clip sheath operator 1640 is operated to slide the clip sheath 164 proximally relative to the clip sheath core 165 until the clip 130 exits the clip sheath 164. Operating the clamp guide wire operator 1660 causes the guide wire 166 to slide proximally relative to the clamp sheath core 165 to effect a gradual release of the clamp 130. Due to the shape memory of the clamp 130, when the guide wire 166 is gradually released from the clamp 130, the wing 131 rotates around the root 132, and the clamp 130 transforms from the second configuration to a third configuration (meaning that the wing 131 rotates around the root 132 and abuts against the outer surface of the sewing segment 112), when the patient's tissue leaflets and adjacent chordae tendineae are clamped between the wing 131 and the sewing segment 112.

(6) As shown in fig. 15a-15c, the stent sheath operator 1620 is operated such that the stent sheath slides axially proximally such that the sewing segment 112 is fully released and the patient's tissue leaflets and adjacent chordae tendineae are clamped between the wings 131 and the sewing segment 112.

(7) Operating the sheath operator 1610 causes the sheath 161 to slide axially distally until the distal end of the sheath 161 touches the introducer, and the delivery system 160 is then withdrawn from the heart apex.

The second embodiment is as follows:

in order to improve the positioning and anchoring effect, as shown in fig. 16a and 16b, the present invention provides a stent-valve prosthesis 200, which comprises a stent 210, valve leaflets (not shown) and clamping elements 230, wherein the stent 210 comprises a support section 211 and a valve sewing section 212, the proximal end of the support section 211 is connected with the distal end of the valve sewing section 212, the valve leaflets are connected with the valve sewing section 212, the support section 211 is placed above the valve annulus of a patient and abuts against atrial tissue after being released, the stent-valve prosthesis 200 comprises two clamping elements 230, the clamping elements 230 are wound by shape memory alloy wires, or the clamping elements 230 are cut and shaped by shape memory alloy tubes.

The clamping member 230 includes two

wings

231a and 231b, the wings 231 have roots 232 parallel to the longitudinal axis of the stent 210 and can rotate around the roots 232, the roots 232 are fixedly connected to the outer surface of the distal portion of the sewing section 212 by gluing, welding, winding, clamping, etc., and the clamping member 230 is fixedly connected to the outer surface of the sewing section 212 through the roots 232. During release the wings 231 are displaced in the radial direction of the valve sewing section 212. Through the patient's adjacent tissue leaflet interface, between the leaflets and the heart wall, and then rotated about the roots 232 and against the outer surface of the valve sewing section 212. The side wings 231 are arc-shaped structures, the side wings 231 are unfolded along the outer surface of the valve sewing section 212 in a natural state, and the tissue leaflets and adjacent chordae tendineae of the patient after the side wings 231 are released are clamped between the side wings 231 and the valve sewing section 212. Preferably, the flanks 231 located on both sides of the root 232 of the clamp 230 are in a free state in an open loop configuration. The advantage of this design is to avoid the side wings 131 on both sides entering a sheath at the same time, which results in an increase in the size of the sheath. Preferably, the side wings 231 on both sides of the clamping member 230 are of an integral structure wound by shape memory alloy wires, or the side wings 231 on both sides of the clamping member 230 are integrally cut by shape memory alloy tubes.

As shown in fig. 17a-17c, to achieve the above technical solution, the present invention further provides a delivery system 260 of a stent-valve prosthesis, wherein the delivery system 260 comprises a stent-valve prosthesis, an outer sheath 261, a stent sheath 262, a stent sheath core 263 and a clamping member sheath 264, the stent-valve prosthesis comprises a stent, valve leaflets (not shown) and clamping members 230, the stent comprises a support section 211 and a valve sewing section 212, the stent sheath 262 and the clamping member sheath 264 are positioned in the outer sheath 261, the clamping member sheath 264 is positioned outside the stent sheath 262, the distal end of the clamping member sheath 264 is flexible, the valve sewing section 212 is positioned in the inner distal end part of the stent sheath 262 after being compressed, the support section 211 is positioned in the outer sheath 261 after being compressed, the proximal end of the valve sewing section 212 abuts against the distal end of the stent sheath core 263, the stent sheath core 263 is positioned in the stent sheath 262, the clamp 230 is compressed and positioned within the distal portion of the clamp sheath 264, the proximal end of the outer sheath 261 is fixedly attached to the outer sheath operator 2610, the proximal end of the stent sheath 262 is fixedly attached to the stent sheath operator 2620, the proximal end of the stent sheath core 263 is fixedly attached to the stent sheath core operator 2630, and the proximal end of the clamp sheath 264 is fixedly attached to the clamp sheath operator 2640.

The

side wings

231a and 231b on both sides of the clip 230 are compression loaded in the two clip sheaths 264a and 264b, respectively. As shown in fig. 17d, in one embodiment, the distal portion of the clip sheath 264 is provided with a slit 2642. The slits 2642 are oriented such that the distal portion of the clip sheath 264 has at least two bends, and the distal portion of the clip sheath 264 is capable of flexible bending in compliance with the bends. The clamping member sheath 264 further has a clamping member sheath core 265, a distal end of the clamping member sheath core 265 is flexible, the distal end of the clamping member sheath core 265 abuts against the clamping member 230, and a proximal end of the clamping member sheath core 265 is fixedly connected to the clamping member sheath core operating member 2650.

The distal end of the clip sheath 264 and the distal end of the clip sheath core 265 of the present invention are both flexible, and manipulation of a handle located outside the patient's body causes the clip sheath 264 to arch in the direction of the ventricular wall, and the clip sheath 264 with the shoulder 231 located therein arches radially from the patient's adjacent tissue leaflet interface to between the leaflets and the ventricular wall; the process is reversible, and the handle outside the patient body is operated, for example, the clamping piece sheath 264 is restored to the non-arched state, so that the doctor can adjust the positioning for many times, and the positioning effect is improved. After positioning is complete, the handle outside the patient's body is manipulated so that the clip sheath 264, with the wings 231 therein, is rotated about the root 232 while the patient's tissue leaflets and adjacent chordae tendineae are clamped between the clip sheath 264 and the valve sewing section 212. Finally withdrawing the clip sheath 264 relative to the clip sheath core 265, the wings 231 are gradually released, and after the wings 231 are released, the patient's tissue leaflets and adjacent chordae tendineae are clamped between the wings 231 and the valve sewing section 212.

The operation of the delivery system 260 for a stent-valve prosthesis according to the present invention will be described step by step as follows:

(1) as shown in fig. 18a-18c, a delivery system 260 of the stent-valve prosthesis is provided, the delivery system comprising a stent-valve prosthesis, an outer sheath 261, a stent sheath 262, a stent sheath core 263 and a holder sheath 264, the stent-valve prosthesis comprising a stent, valve leaflets (not shown) and holders, the stent comprising a support section 211 and a sewing section 212, each holder comprising a single or two wings 231, the wings 231 having roots 232 parallel to the longitudinal axis of the stent 210, the wings 231 being rotatable around the roots 232, the holders being fixedly attached to the outer surface of the distal part of the sewing section 212 by means of the roots 232.

The wings 231 of the clip are preloaded into the clip sheath 264 after being compressed in a direction opposite to the direction of deployment along the root 232, and assume a first configuration (i.e., a state in which the clip is compressed within the lumen); retracting the sewn valve section 212 into the stent sheath 262 after compression; the compressed spreader section 211, the clip sheath 264, and the stent sheath 262 are then received within the outer sheath 261. The distal end of the outer sheath 261 is transapically accessed to the patient's mitral valve.

(2) 19a-19c, the stent-valve prosthesis is delivered to the target site of the patient, and the outer sheath operator 2610 is operated to cause the outer sheath 261 to slide axially proximally until the flared section 211 is released for deployment; adjusting the position of the spreader section 211 for placement over the patient's annulus and against atrial tissue; the stent sheath operator 2620 is operated to slide the stent sheath 262 in the axial direction until the valve sewing section 212 is partially released.

(3) As shown in fig. 20a-20c, the position of the root 232 is adjusted such that the root 232 is proximate to the interface of the adjacent tissue leaflets of the patient, and the gripping member sheath operator 2640 and the gripping member sheath core operator 2650 are pushed together such that the gripping member sheath 264 with the wings 231 therein in the heart is radially arched along the valve sewing section 212 and passes from the interface of the adjacent tissue leaflets of the patient to the space between the leaflets and the heart wall, whereupon the gripping member is transformed from the first configuration to the second configuration; the process is reversible, and the clamping member sheath operation member 2640 and the clamping member sheath core operation member 2650 are integrally pulled to restore the clamping member sheath 264 to a non-arched state, so that a doctor can adjust and position for many times, and the positioning accuracy is improved.

(4) As shown in fig. 21a-21c, rotating the clamp sheath operator 2640 causes the clamp sheath 264 with the shoulder 231 therein to rotate about the heel 232, and the clamp 230 transitions from the second configuration to a third configuration (meaning that the shoulder 231 rotates about the heel 232 and abuts the outer surface of the sewing segment 212), when the patient's tissue leaflets and adjacent chordae tendineae are clamped between the clamp sheath 264 and the sewing segment 212.

(5) As shown in fig. 22a-22c, the clamp sheath operator 2640 is operated such that the clamp sheath 264 slides proximally relative to the clamp sheath core (not shown) and the clamp 230 is fully released, with the patient's tissue leaflets and adjacent chordae tendineae clamped between the clamp 230 and the valve sewing segment 212.

(6) As shown in fig. 23a-23c, the stent sheath operator 2620 is operated such that the stent sheath (not shown) slides proximally relative to the stent sheath core (not shown) and the valve sewing segment 212 is fully released, with the patient's tissue leaflets and adjacent chordae tendineae clamped between the clamp 230 and the valve sewing segment 212.

(7) Operating the sheath manipulating member 2610 causes the sheath 261 to slide axially distally until the distal end of the sheath 261 touches the guide head, and the delivery system 260 is then withdrawn from the body from the apex of the heart.

The third concrete embodiment:

the stent-valve prosthesis 300 of the present invention may also be applied in the field of tricuspid valve replacement. As shown in fig. 24a and 24b, the tricuspid valve structure 020 is an ensemble of the tricuspid valve annulus 021, septal flap 022, anterior flap 023, posterior flap 024, chordae tendineae 025, papillary muscles 026, right atrium 027, and right ventricle 028. As shown in fig. 24c and 24d, in one embodiment, the stent-valve prosthesis 300 comprises three clamping members 330, each clamping member 330 comprises two wings 331, each wing 331 has a root 332 parallel to the longitudinal axis of the stent 310, the clamping members 330 are fixedly connected to the outer surface of the distal portion of the valve sewing section 312 through the roots 332, and the wings 331 can rotate around the roots 332. When the retaining member 310 is released, the root portion 332 is located at the interface of the anterior valve 023 and the septal valve 022 of the patient's tricuspid valve, or the root portion 332 is located at the interface of the anterior valve 023 and the posterior valve 024 of the patient's tricuspid valve, or the root portion 332 is located at the interface of the posterior valve 024 and the septal valve 022 of the patient's tricuspid valve.

Finally, it should be understood that the above-mentioned embodiments are merely preferred embodiments of the present invention, and not intended to limit the present invention, and any modifications, equivalents and improvements made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A stent-valve prosthesis is characterized by comprising a stent, valve leaflets and clamping pieces, wherein the stent comprises a supporting section and a valve sewing section, the proximal end of the support section is connected with the distal end of the valve sewing section, the valve leaflet is connected on the valve sewing section, the support segment, upon release, is placed against the annulus of the patient and against atrial tissue, the clamp including one or more wings, the lateral wing is provided with a root part which is parallel to the longitudinal axis of the bracket, the clamping piece is fixedly connected to the outer surface of the valve sewing section through the root part, the lateral wing can rotate around the root part, one end of the clamping piece is fixedly connected with the outer surface of the valve sewing section, the clamping piece has three forms from compression to complete release in sequence, and the first form is that the side wing is compressed in the control device; the second form is that the side wings extend along the radial direction of the valve sewing section and penetrate through the valve leaflet boundary of adjacent tissues to reach between the valve leaflets and the heart wall; the third form is that the lateral wings extend along the circumferential direction of the valve sewing section and are attached to the outer surface of the valve sewing section, and the lateral wings rotate around the circumferential direction of the root and are attached to the outer surface of the valve sewing section when the clamping piece is converted from the second form to the third form.

2. The stent-valve prosthesis of claim 1, wherein the root is disposed on a distal portion of the valve sewing segment or the root is fixed at a connection of the valve sewing segment and the support segment.

3. The stent-valve prosthesis of claim 1, wherein the wings are arcuate in configuration, the wings being circumferentially deployable along an outer surface of the sewn section of the valve in a natural state.

4. The stent-valve prosthesis of claim 1, wherein the wings are released before the valve sewing section is released.

5. The stent-valve prosthesis of claim 1, wherein the holder is a plurality of holders.

6. The stent-valve prosthesis of claim 5, wherein the side wings are symmetrically disposed when the same clip includes an even number of side wings.

7. The stent-valve prosthesis of claim 1, wherein each of the wings has a single or a plurality of consecutive arc-shaped configurations.

8. A delivery system for a stent-valve prosthesis according to claims 1 to 7, comprising a stent-valve prosthesis comprising a stent, leaflets and a clamp, an outer sheath, a stent sheath core and a clamp sheath, the stent comprising a support section and a sewn-valve section, the stent sheath and the clamp sheath being disposed within the outer sheath, the clamp sheath being disposed outside the stent sheath, the sewn-valve section being compressed and disposed within a distal portion of the stent sheath, the support section being compressed and disposed within a distal portion of the outer sheath, a proximal end of the sewn-valve section being connected to a distal end of the stent sheath core, the stent sheath core being disposed within the stent sheath, the clamp being compressed and disposed within a distal portion of the clamp sheath, a proximal end of the outer sheath being fixedly connected to an outer sheath operator, the proximal end of the bracket sheath is fixedly connected to the bracket sheath operating part, the proximal end of the bracket sheath core is fixedly connected to the bracket sheath core operating part, and the proximal end of the clamping piece sheath is fixedly connected to the clamping piece sheath operating part.

9. The delivery system of a stent-valve prosthesis of claim 8, wherein a holder sheath core is further disposed in the holder sheath, a distal end of the holder sheath and a distal end of the holder sheath core are both flexible, the distal end of the holder sheath core is in contact with the holder, and a proximal end of the holder sheath core is fixedly connected to the holder sheath core operating member.

10. The delivery system of a stent-valve prosthesis of claim 8, wherein the clip is straightened to compress within the clip sheath in a direction opposite the deployment direction when the clip needs to be compressed into the clip sheath.

11. The delivery system of claim 8, further comprising a clip guide wire disposed within the clip sheath, wherein the wings compress along the root in a direction opposite the deployment direction to form a slit, wherein when the clip is in the first configuration, a distal end of the clip guide wire passes through the slit of the clip, and wherein a proximal end of the clip guide wire is fixedly coupled to the clip guide wire operator.

12. The delivery system of a stent-valve prosthesis of claim 8, wherein the distal portion of the clip sheath is provided with a slit.