CN118217051A

CN118217051A - Valve stent and valve prosthesis system

Info

Publication number: CN118217051A
Application number: CN202211641994.6A
Authority: CN
Inventors: 艾辽元; 刘明
Original assignee: Shanghai Yiqiao Medical Instrument Co ltd
Current assignee: Shanghai Yiqiao Medical Instrument Co ltd
Filing date: 2022-12-20
Publication date: 2024-06-21

Abstract

The invention discloses a valve stent and a valve prosthesis system. The valve stent comprises: a sealing support for cooperating with the annulus; the fixed bracket is arranged at the outflow end of the sealing bracket and is used for fixing the first valve leaflet; the anchoring support is arranged at the outflow end of the sealing support and comprises an anchoring rod and a connecting rod, wherein the anchoring rod is connected to the joint of the two connecting rods, and the anchoring rod has three state modes relative to the two connecting rods which are connected: in the first state mode, the anchoring rod and the two connecting rods connected with each other are arranged on the circumferential surface of the valve bracket; in a second state mode, the plane formed by the anchoring rod and the two connected connecting rods is inclined relatively and used for capturing the second valve leaflet; in the third state mode, the plane formed by the anchoring rod and the two connected connecting rods is inclined relatively, and the inclined included angle is smaller than that of the second state mode and is used for clamping the second valve leaflet. The valve prosthesis comprises a first leaflet, a skirt, and a valve stent; the valve prosthesis system includes a valve prosthesis and a delivery system.

Description

Valve stent and valve prosthesis system

Technical Field

The invention relates to the technical field of medical instruments, in particular to a valve support and a valve prosthesis system.

Background

The realization of the blood supply function of the heart is not separated from the normal heart valve. Heart valves refer to valves between the atrium and ventricle or between the ventricle and arterial blood vessels, the primary function being to prevent regurgitation of blood, to ensure that the heart's blood flows from the atrium to the ventricle, or from the ventricle to the artery (aorta/pulmonary). The heart valve includes: mitral valve between left ventricle and left atrium, tricuspid valve between right ventricle and right atrium, aortic valve between left ventricle and aorta, and pulmonary valve between right ventricle and pulmonary artery. When the heart valve is not fully closed due to congenital or acquired reasons or the valve is in a narrow and other pathological conditions due to calcification and the like, the blood supply of a human body is insufficient, the conditions of palpitation, shortness of breath, dizziness and the like are easily caused, the life quality of a patient is influenced, and the life is possibly endangered in serious cases. The incidence of degenerative heart valve disease is gradually rising as the population ages. For severe heart valve disease, treatment by implantation of prosthetic heart valves is often required, which is also the most effective treatment at present. The artificial heart valves used today can be divided from materials into mechanical valves (made of pyrolytic carbon) and biological valves (made of biological tissues of pigs, cattle, etc.). The service life of the mechanical valve is longer, the mechanical valve can support more than 50 years, but related complications are more likely to occur, and the anticoagulant is required to be taken for the whole life and the coagulation function is detected; the design life of the biological valve is only 10-20 years, but only 3-6 months of anticoagulant is needed after operation. Currently, there are two ways of replacing a prosthetic heart valve, one is surgical open chest surgery and one is transcatheter interventional surgery. The surgical valve replacement needs to be performed in the chest opening and extracorporeal circulation in the surgical process, so that the surgical wound is relatively large, the postoperative recovery time is relatively long, and the surgical risk is relatively high for patients with relatively high ages; the intervention valve is used for conveying the artificial valve into the heart valve replacing position to complete the valve replacing operation through the femoral artery or other access way under the condition of not opening the chest. Compared with open chest surgery, the percutaneous catheter intervention surgery has the advantages of small surgical trauma, quick postoperative recovery and small surgical risk, is particularly suitable for patients who are not suitable for surgical valve replacement, and gradually becomes the choice of low-and-medium-risk patients.

For example, there are two kinds of aortic valve diseases, one is aortic stenosis due to aortic valve She Gaihua, etc., and one is aortic valve regurgitation due to degenerative disease, rheumatic heart disease, etc. The process of treating aortic valve diseases through catheter intervention operation is that after the implant for fixing the artificial valve is implanted through the catheter, the implant props up and fixes the native valve, so that the artificial valve works at the original valve position instead of the native valve, and the effect of allowing blood flow to flow unidirectionally is achieved. But the implantation process suffers from several problems: on the one hand, the implant is difficult to accurately position and release, imaging errors and operation errors can cause the implant to be higher or lower, and in addition, the landing position of the implant can be deviated from the target position due to the beating of the heart. Displacement of the implant can cause hemodynamic changes and even increased complications; on the other hand, after the artificial heart valve is fixed, the artificial heart valve needs to bear 100-200mmHg under the action of heart blood flow, and can flow out of a heart chamber under the action of pressure load, possibly press a atrioventricular node, so that atrioventricular conduction is blocked. In particular, for tissues with low calcification of the valve leaflet, the artificial heart valve has insufficient fixation force and higher risk after implantation of the valve stent.

In both domestic and foreign valve prosthesis systems, the fixation of the valve holder is generally suitable for the patient of the valve She Gaihua, the valve being fixed by radial support forces, but displacement of the valve is also unavoidable. Some valve stents are designed by a double-layer stent, so that the appearance size is large, and vascular complications are easily caused in the implantation process.

Disclosure of Invention

The present invention aims to solve at least one of the technical problems existing in the prior art. To this end, the invention proposes a valve stent comprising an anchoring stent, a fixing stent and a sealing stent. The anchoring support comprises one or more anchoring rods and at least two connecting rods, wherein the anchoring rods are connected to the joints of the two connecting rods and are connected with two adjacent fixed supports through the two connecting rods; or the anchoring rod is connected to the joint of the two connecting rods and is connected with the sealing support through the two connecting rods. The cooperation of the anchoring rod and the connecting rod realizes the capture and clamping of the second valve leaflet, and the inflow end of the anchoring rod butts against the sinus floor, and the reaction force provided by the sinus floor can prevent the valve stent from shifting and shifting under the impact of blood flow.

The invention also proposes a valve prosthesis system.

According to an embodiment of the first aspect of the invention, the valve stent comprises: the sealing support is used for being matched with the valve ring; the fixing support is arranged on the outflow channel of the sealing support and is used for fixing the first valve leaflet; the anchor support, the anchor support set up in the outflow way of seal support, the anchor support includes anchor pole and connecting rod, the anchor pole is connected in two the junction of connecting rod, the anchor pole has three kinds of state modes for two that link to each other the connecting rod: in a first state mode, the anchoring rod and the two connected connecting rods are arranged on the circumferential surface of the valve bracket; in a second state mode, the plane formed by the anchoring rod and the two connected connecting rods is inclined relatively so as to leave a space for accommodating the second valve leaflet and be used for capturing the second valve leaflet; in the third state mode, the plane formed by the anchoring rod and the two connected connecting rods is inclined relatively, and the inclination included angle is smaller than that of the second state mode, so that a space for accommodating the second valve leaflet is reserved for clamping the second valve leaflet.

According to some embodiments of the invention, the number of the connecting rods is at least two, the outflow ends of the two connecting rods are intersected at a fulcrum, the anchoring rod is connected with the fulcrum, and the anchoring rod is arranged along the axial direction of the valve bracket; the inflow ends of the two connecting rods are respectively connected with the two adjacent fixed brackets; or the inflow ends of the two connecting rods are connected with the sealing support.

According to some embodiments of the invention, the inflow end of the anchoring rod is provided with a positioning part, the length from the intersecting fulcrum of the two connecting rods to the positioning part is H, and the length of the connecting rod is L; the ratio of the length H to the dimension of the second leaflet in the axial direction when the second leaflet is fully open is in the range of 1/10-2/1; and/or the ratio of said length L to said length H is in the range of 1/10 to 10/1; or the H satisfies the relation: 6 mm.ltoreq.H.ltoreq.20mm, and/or the L satisfies the relation: l is more than or equal to 8mm and less than or equal to 35mm.

According to some embodiments of the invention, the positioning part is in a spherical shape, a quasi-circular shape, an arc shape or a combination of one or more than one of water drop shapes; or the outer surface of the positioning part is provided with a buffer piece, and the buffer piece adopts a buffer material.

According to some embodiments of the invention, the positioning portion is provided with a reference mark for displaying a position under observation of a developing device such as infrared rays or ultrasonic waves.

According to some embodiments of the invention, a first hanging lug is arranged at the outflow end of the anchoring rod, the first hanging lug is in limit fit with a first hooking structure of the conveying system, the length from a fulcrum intersected by the two connecting rods to the first hanging lug is H, and the ratio of the length H to the length H is in the range of 1/20-2/1.

According to some embodiments of the invention, when the anchoring rod is in the second state mode with respect to the two connecting rods connected, the vertical distance from the positioning part to the outer surface of the valve support is D, the ratio of the distance D to the radius of the annulus is in the range of 1/2-2/1; or the h satisfies the relation: h is more than or equal to 2mm and less than or equal to 8mm.

According to some embodiments of the invention, a connecting portion is provided between two adjacent fixing brackets, and the positioning portion is located at an outflow end side of the connecting portion or at an inflow end side of the connecting portion.

According to some embodiments of the invention, when the anchoring rod is in the second state mode or in the third state mode with respect to the two connecting rods connected, the anchoring rod forms an angle α with the connecting rods, α satisfying the relation: alpha is less than or equal to 90 degrees.

An embodiment of a valve prosthesis system according to the second aspect of the invention comprises: a valve prosthesis and a delivery assembly, the valve prosthesis comprising a first leaflet, a skirt, the first leaflet and the skirt being disposed on the valve stent according to an embodiment of the first aspect of the invention; the delivery assembly includes: a delivery body having a delivery lumen disposed therein for loading and delivering the valve prosthesis.

Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention.

Drawings

The foregoing and/or additional aspects and advantages of the invention will become apparent and may be better understood from the following description of embodiments taken in conjunction with the accompanying drawings in which:

FIG. 1 is a schematic structural view of a valve prosthesis according to an embodiment of the present invention;

FIG. 2 is a schematic illustration of a valve stent in accordance with an embodiment of the present invention as it expands;

FIG. 3 is a schematic view of a valve stent in accordance with an embodiment of the present invention as compressed;

FIG. 4 is a schematic view of the structure of an anchor rod of a valve stent according to an embodiment of the present invention when expanded;

FIG. 5 is a schematic view of the structure of a valve stent according to an embodiment of the present invention when expanded;

FIG. 6 is a schematic view of a valve holder holding a second leaflet according to an embodiment of the present invention;

FIG. 7 is a schematic view of a positioning portion and a buffer according to an embodiment of the present invention;

FIG. 8 is a simplified illustration of a valve stent in accordance with an embodiment of the present invention as it expands;

FIG. 9 is a schematic view of a first hooking structure and a second hooking structure of a conveying system according to an embodiment of the present invention;

FIG. 10 is a schematic structural view of a valve prosthesis implantation procedure according to an embodiment of the present invention;

FIG. 11 is a schematic structural view of a valve prosthesis implantation procedure according to an embodiment of the present invention;

FIG. 12 is a schematic view of a valve stent according to another embodiment of the present invention in compression;

fig. 13 is a schematic view of a valve stent according to another embodiment of the present invention as it expands.

Reference numerals:

1000. A valve prosthesis;

100. a valve stent;

10. A sealing support; 11. a first grid bar;

20. A fixed bracket; 21. a holding section; 22. a fixing part; 23. a second hanger; 24. a second grid bar; 25. a connection part;

30. An anchor bracket; 31. an anchor rod; 32. a connecting rod; 33. a buffer member; 34. a positioning part; 35. a first hanger;

200. a first leaflet; 300. a skirt edge; 400. an annulus; 500. a second leaflet; 600. a first hooking structure; 700. and a second hooking structure.

Detailed Description

Embodiments of the present invention will be described in detail below, with reference to the accompanying drawings, which are exemplary.

It should be noted that, in the following detailed description of the embodiments of the present invention, "inflow end", "inflow channel" refer to the end into which blood flows from the valve prosthesis 1000, and "outflow end", "outflow channel" refer to the end from which blood flows from the valve prosthesis 1000.

Although in the description of the present embodiment the valve prosthesis 1000 system has been described in terms of treatment of aortic valve disorders, the interventional valve prosthesis 1000 system may equally well be used in the treatment of other valve disorders of the heart, such as mitral valve, tricuspid valve, pulmonary valve, etc., as will be appreciated by those skilled in the art.

The first leaflet 200 of the valve prosthesis 1000 can be made of any suitable material, including biological valves obtained from animals such as pigs, sheep, cattle, etc., or prosthetic biological valves made of freshly wrapped connective tissue, or biological tissue cultured with cell culture techniques, as well as nitinol prosthetic materials or structures. The pericardium of an animal is the preferred material for prosthetic valves, can achieve optimal leaflet design, and can collapse into smaller diameter delivery systems; meanwhile, the animal pericardium has better biocompatibility, and can reduce the time for patients to take immunosuppressive drugs.

The following describes a valve stent 100 according to an embodiment of the present invention with reference to fig. 1-13, and the present invention also proposes a valve prosthesis 1000 system having the valve stent 100 described above.

As shown in fig. 1-8, a valve prosthesis 1000 of an embodiment of the present invention includes: the first leaflet 200, the valve holder 100, and the skirt 300, wherein the valve holder 100 is the main body structure of the valve prosthesis 1000. The valve stent 100 includes a sealing stent 10, a fixing stent 20, and an anchoring stent 30.

The anchoring stent 30 is disposed at the outflow end of the sealing stent 10, the anchoring stent 30 is used for capturing and clamping the second leaflet 500, for example, the anchoring stent 30 comprises an anchoring rod 31 and a connecting rod 32, the anchoring rod 31 and the connecting rod 32 cooperate with each other to capture and clamp the second leaflet 500, thereby realizing the accurate release of the valve prosthesis 1000, and preventing the movement of the second leaflet 500 from affecting the opening area of the first leaflet 200; at the same time, the anchoring rod 31 penetrates into the aortic sinus floor, and the reaction force provided by the sinus floor realizes the firm fixation of the valve prosthesis 1000, preventing the valve prosthesis 1000 from moving and shifting to the outflow tract under the impact of blood flow.

The fixing bracket 20 is disposed at the outflow end of the sealing bracket 10, and the fixing bracket 20 is used to fix the first leaflet 200. The outer contour of the fixing bracket 20 formed by surrounding is cylindrical or conical, and is used for providing a supporting frame for opening and closing movement of the artificial valve leaflet when the artificial valve leaflet is fixed, for example, the fixing bracket 20 comprises a holding part 21 and a fixing part 22, the first valve leaflet 200 can be sewed on the fixing bracket 20, and in particular, the fixing part 22 can be one or more hole type structures or groove type structures for assisting in positioning and fixing of the sewed material. The fixing support 20 can provide a supporting force for opening the valve annulus 400 and a stabilizing force for improving the movement of the first valve leaflet 200, so that the normal opening and closing of the first valve leaflet 200 and the hemodynamic effect are ensured.

The sealing stent 10 is positioned at the annulus 400 and the left ventricular outflow tract after implantation, the annulus 400 is spread by a circumferential structure and anchored at the outflow ends of the annulus 400 and the left ventricular outflow tract by means of radial supporting force, and the fixing force of the valve prosthesis 1000 can be improved while preventing the occurrence of paravalvular leakage. The skirt 300 may prevent blood flow from leaking from the edge of the valve prosthesis 1000 or from the gap between the outer edge of the valve prosthesis 1000 and the first leaflet 200, affecting the function and hemodynamic effects of the valve prosthesis 1000, alleviating related complications.

Wherein the first leaflet 200 is an artificial leaflet and the second leaflet 500 is a native leaflet, i.e., the artificial leaflet is fixed on the fixed bracket 20, the native leaflet is clamped between the anchoring rod 31 and the connecting rod 32. After the valve prosthesis 1000 is implanted, the primary valve leaflet is spread to form a circular passage to construct a blood flow channel, the structural design of the artificial valve leaflet simulates the tissue structure of the primary valve leaflet, when the ventricle contracts, the valve leaflet expands and opens to ensure the blood to flow out, and when the ventricle expands, the valve leaflet closes and closes to prevent the blood from flowing back, thereby replacing the function of the primary valve leaflet. While the radial support force created by the expansion of the valve prosthesis 1000 enhances the force of the artificial leaflet fixation.

As shown in fig. 2, an anchor stent 30 is provided at the outflow end of the sealing stent 10 for capturing and clamping the second leaflet 500. The anchor bracket 30 includes: the number of the anchor rods 31 and the number of the connecting rods 32 is at least 2, and the number of the anchor rods 31 can be one or more. One or more anchor rods 31 are connected to the adjacent two fixed brackets 20 through two connecting rods 32 connected to each other, specifically, inflow ends of the two connecting rods 32 are connected to the adjacent two fixed brackets 20, outflow ends of the two connecting rods 32 intersect at a fulcrum, and the anchor rods 31 are connected to the fulcrum. The fulcrum then resembles the fulcrum in a lever, enabling the anchoring bar 31 to cooperate with the connecting bar 32 by leverage forces, thereby achieving capture and clamping of the second leaflet 500.

Wherein, the number of the anchoring rods 31 can be three, the symmetry matching with the second valve leaflet 500 can be realized by the three anchoring rods 31, and the rotation accuracy, symmetry and stability of the valve stent 100 are ensured by the three anchoring rods 31. In practical applications, the number of the anchoring bars 31 is not limited to three, and may be any one or more.

The anchoring bar 31 has three modes of state with respect to the two connecting bars 32 connected:

As shown in fig. 3, when the valve stent 100 is delivered in the delivery system, there is a first state mode in which the anchoring bar 31 and the two connecting bars 32 connected thereto are on the circumferential surface of the valve stent 100 since the valve stent 100 is in a compressed state as a whole.

As shown in fig. 4 and 10, when the middle region of the valve stent 100 is first released, there is a second state mode, specifically, the positioning portion 34 of the inflow end of the anchoring bar 31 is a free end, the positioning portion 34 end is released first, and the first hanging tab 35 end of the anchoring bar 31 is not released, that is, only one end of the anchoring bar 31 is restrained at this time, the positioning portion 34 end of the anchoring bar 31 is opened under leverage and pushing force of the connecting bar 32 due to position change, and the maximum opened size of the anchoring bar 31 is achieved under the cooperation of the delivery system. The opening of the anchoring bar 31 causes the plane formed by the anchoring bar 31 and the two connecting bars 32 connected thereto to be inclined relatively, so that a certain space is formed between the anchoring bar 31 and the two connecting bars 32, in which the second leaflet 500 can be fittingly received. In turn, the anchoring bar 31 is adjusted to be placed between the second leaflet 500 and the annulus 400, with the two connecting bars 32 connected to the anchoring bar 31 being located at the other side of the second leaflet 500, thereby precisely capturing the second leaflet 500.

As shown in fig. 6 and 11, when the valve stent 100 is completely released, there is a third state mode in which the first suspension tab 35 end of the anchoring rod 31 loses the constraint of the delivery system due to the complete release of the valve stent 100, the inclination angle of the plane formed by the anchoring rod 31 and the two connecting rods 32 connected thereto becomes smaller than that of the second state mode under the leverage and the pushing force generated during the deformation recovery of the connecting rods 32, i.e., the space between the anchoring rod 31 and the two connecting rods 32 becomes smaller, and the second leaflet 500 is still accommodated in cooperation in the space. That is, in the third state mode, the anchoring rod 31 and the two connecting rods 32 connected with each other form a clamping effect to clamp the second leaflet 500, thereby realizing the accurate release of the valve stent 100, and simultaneously, preventing the upper edge of the second leaflet 500 from swinging along with the scouring of blood flow, thereby solving the problem that the second leaflet 500 affects the opening area of the first leaflet 200.

The matched structure design of the anchoring rod 31 and the connecting rod 32 ensures the clamping acting force of the anchoring rod 31 and the connecting rod 32 on the second valve leaflet 500 on one hand, and realizes the capturing and the tight clamping of the second valve leaflet 500; on the other hand, the clamping action of the anchoring bar 31 and the two connecting bars 32 connected thereto secures the second leaflet 500, and can prevent the movement of the second leaflet 500 from affecting the opening area of the first leaflet 200; at the same time, the valve prosthesis 1000 can be prevented from moving towards the outflow tract under the impact of blood flow, and the displacement of the valve prosthesis 1000 is effectively avoided. Specifically, the anchoring rod 31 may be deep into the aortic sinus floor, at which time the anchoring rod 31 is positioned between the second leaflet 500 and the annulus 400, and two connection rods 32 connected to the anchoring rod 31 are positioned at the other side of the second leaflet 500, thereby achieving capturing and clamping of the second leaflet 500. The reaction force provided by the sinus floor to the anchoring rod 31 enables the valve prosthesis 1000 to be firmly fixed at the aortic valve, thereby preventing the valve prosthesis 1000 from jumping under the action of blood pressure, reducing the risk of displacement, avoiding damage to tissues and complications caused by the valve prosthesis 1000, and the like.

As shown in fig. 2-4, the anchor bracket 30 further includes: a positioning portion 34, the positioning portion 34 being provided at the inflow end of the anchor rod 31. The length from the fulcrum at which the two connecting rods 32 intersect to the positioning portion 34 is H, and the ratio of the length H to the dimension of the second leaflet 500 in the axial direction when the second leaflet is fully opened is preferably in the range of 1/10 to 2/1.

Preferably, the ratio of the length H to the dimension of the second leaflet 500 in the axial direction when the second leaflet is fully open is in the range of 1/3-4/3, e.g., 6 mm.ltoreq.H.ltoreq.20 mm.

Preferably, the design length of L is required to ensure proper positioning of the positioning portion 34 and to reduce the length of the sealing stent 10 under the annulus to reduce the blocking effect of the valve stent 100 on the atrioventricular conduction bundle, preferably the length of L is 8-35 mm.

The length H of the fulcrum-to-positioning portion 34 where the two connecting rods 32 intersect should match the size and shape of the second leaflet 500 in the axial direction when it is fully opened, and the length H should be such that the anchoring rod 31 can penetrate deep into the aortic sinus floor. The dimension of the second leaflet 500 in the axial direction is about 15 + 1mm when fully opened, depending on the anatomy of the human body, while the length H may be greater or less than the dimension of the second leaflet 500 in the axial direction when fully opened, due to the ability of the second leaflet 500 itself to deform, i.e., compress and expand. When the length H is greater than the dimension of the second leaflet 500 in the axial direction when the second leaflet 500 is fully opened, the anchoring rod 31 and the connecting rod 32 can clamp the second leaflet 500 in the expanded state so as to abut against the sinus floor, so that the natural form of the second leaflet 500 can be ensured, the related complications of the second leaflet 500 can be reduced, but the excessive length H can increase the overall length of the valve stent 100, thereby reducing the overbending capability of the valve stent 100; when the length H is smaller than the dimension of the second leaflet 500 in the axial direction when it is fully opened, the anchoring rod 31 and the connecting rod 32 may clamp the second leaflet 500 in a compressed state against the sinus floor, the reduction of the length H may reduce the dimension of the valve stent 100 as a whole in the axial direction, thereby improving the overbending capability of the valve stent 100, but too small a length H may increase the compression degree of the second leaflet 500, the compression degree of the second leaflet 500 may affect the clamping of the second leaflet 500 by the valve stent 100, and if the compression degree of the second leaflet 500 is too high, the anchoring rod 31 may slip out of the sinus floor, thereby reducing the axial supporting force and even causing the displacement of the valve stent 100. In combination, the ratio of the length H to the dimension of the second leaflet 500 in the axial direction when fully open is preferably in the range of 1/10 to 2/1; preferably, the ratio of the length H to the dimension of the second leaflet 500 in the axial direction when fully open is in the range of 1/3-4/3.

As shown in fig. 7, the positioning portion 34 has one or more of a spherical shape, a quasi-circular shape, an arc shape, and a drop shape, so that the contact area between the positioning portion 34 and the second leaflet 500 and the annulus 400 is increased, so that the anchoring rod 31 does not damage the vessel wall and adjacent tissues when the anchoring rod 31 is inserted into the bottom of the aortic sinus.

And, the anchor bracket 30 further includes: and a buffer member 33, wherein the buffer member 33 is disposed on the outer surface of the positioning portion 34. The buffer member 33 may be fixed on the outer surface of the positioning portion 34 by a physical or chemical connection manner such as suturing, glue bonding, etc., wherein the buffer member 33 has a good buffering effect, so that buffering between the positioning portion 34 and the second leaflet 500 and the valve ring 400 can be provided, and the acting force of the positioning portion 34 on the second leaflet 500 and the valve ring 400 is reduced, so that when the anchor rod 31 is inserted into the aortic sinus bottom, the anchor rod 31 will not cause damage such as penetration or tearing of the vessel wall and adjacent tissues. The cushion material 33 may be a material having a relatively high elastic deformability, such as a PTFE film, a resin, or a rubber.

Further, to better view the implantation position and movement of the valve prosthesis 1000, reference marks may be provided on the positioning portion 34, and the reference marks may display the position under the observation of a developing device such as infrared or ultrasonic, thereby helping a doctor to more accurately confirm the shape and position of the valve prosthesis 1000.

In order to realize the cooperation between the anchoring bracket 30 and the delivery system, as shown in fig. 2 and 9, the outflow end of the anchoring rod 31 is provided with a first hanging tab 35, and the first hanging tab 35 is in limit cooperation with a first hooking structure 600 of the delivery system. The shape of the first suspension loop 35 is complementary to the shape of the first hooking means 600 of the delivery system for implantation of the valve stent 100, and by this complementary fit in shape and the binding of the delivery system against the outside, a fixation of the compressed valve stent 100 in the delivery system is achieved. When the valve prosthesis 1000 is released, the anchoring bar 31 is transformed from the first state mode to the second state mode and from the second state mode to the third state mode with respect to the two connecting bars 32 connected. In the process of switching from the second state mode to the third state mode, the valve stent 100 loses the restraint of the delivery system, and returns to the expanded state under the action of the self-deformation force, i.e., the first suspension loop 35 is also separated from the limit fit state of the first hooking structure 600 of the delivery system under the action of the self-deformation force, so that the valve stent is separated from the delivery system.

As shown in fig. 4, the length from the intersecting fulcrum of the two connecting rods 32 to the first hanging lug 35 is H, and the ratio of the length H to the length H is preferably in the range of 1/20-2/1; or the h satisfies the relation: h is more than or equal to 2mm and less than or equal to 8mm. According to the size of the annulus 400 and the size of the aortic root, the length range of the anchoring rod 31, i.e., the length range in which the length H is added to the length H, can be calculated, and the length H can be further limited to meet the requirement of the opening size of the anchoring rod 31. Preferably, i.e. the ratio of length H to length H is in the range of 1/10 to 4/3, since length H is preferably in the range of 6mm to 20mm, and length H is preferably in the range of 2 to 8mm.

As shown in FIG. 4, when the anchoring bar 31 is in the second state mode relative to the two connecting bars 32 connected, the positioning portion 34 is located at a vertical distance D from the outer surface of the valve holder 100, preferably in a ratio of the distance D to the radius of the annulus 400 in the range of 1/2-2/1, e.g., 2 mm. Ltoreq.D.ltoreq.14 mm. The purpose of the anchoring rod 31 deployment is to capture the second leaflet 500 and deep into the sinus floor. The length of the anchoring rod 31 and the depth of implantation of the valve prosthesis 1000 can be determined by the position of the sinus floor of the second leaflet 500. Since the second leaflet 500 is always in an open-close alternating state and the frequency is very high, the difficulty of capturing the second leaflet 500 is great. The anchoring rod 31 is opened under the action of two forces, namely, the positioning part 34 end of the anchoring rod 31 is released firstly and loses the binding force of the conveying system to open, and the connecting rod 32 has a certain supporting effect on the anchoring rod 31 during the position change to open the anchoring rod 31. In order to achieve easy capture of the second leaflet 500, the maximum opening radius of the anchoring rod 31, i.e. the vertical distance D of the positioning portion 34 to the outer surface of the valve holder 100 when the anchoring rod 31 is in the second state mode with respect to the two connecting rods 32 connected, is not smaller than the measured radius of the annulus 400, so that capture of the second leaflet 500 is achieved irrespective of whether the second leaflet 500 is in the open state or the closed state, and the radius of the aortic root is not exceeded, in order to prevent the anchoring rod 31 from seizing or scratching the tissue wall during movement, and therefore the ratio of the vertical distance D of the positioning portion 34 to the outer surface of the valve holder 100 to the radius of the annulus 400 is preferably in the range of 1/2-2/1, preferably the ratio of the vertical distance D of the positioning portion 34 to the outer surface of the valve holder 100 to the radius of the annulus 400 is in the range of 1/2-2/1.

As shown in fig. 2, a fixing bracket 20 is provided at the outflow end of the sealing bracket 10 for fixing the first leaflet 200. The fixing bracket 20 includes: the number of the holding parts 21 is at least two, and the number of the fixing parts 22 may be one or more. The fixing portion 22 is disposed at the outflow end of the holding portion 21, and the fixing portion 22 is used for fixing the first leaflet 200, i.e., at least one portion of the first leaflet 200 is connected to the fixing portion 22 of the valve holder 100 and effectively fixing, preventing the valve prosthesis 1000 from being degraded and damaged due to friction. Wherein the fixing portion 22 is constructed in a plurality of holes or a groove-shaped structure, which can facilitate the fixing of the first leaflet 200 to the fixing bracket 20. For example, the first leaflet 200 can be sutured to the securing bracket 20, with one or more hole-type structures or channel-type structures of the securing portion 22 being used to assist in the positioning and securing of the suturing material. The outer contour of the fixing bracket 20 formed by enclosing is cylindrical or conical, and is used for providing a supporting frame for opening and closing movement of the artificial valve leaflet when the artificial valve leaflet is fixed.

As shown in fig. 5, an arc-shaped connecting portion 25 is provided between two adjacent fixing brackets 20, and a positioning portion 34 may be provided on the inflow end side of the connecting portion 25 or on the outflow end side of the connecting portion 25. In an alternative embodiment, the positioning portion 34 is disposed at the outflow end side of the connection portion 25, that is, the positioning portion 34 is close to the outflow end of the connection portion 25, and the positioning portion 34 and the connection portion 25 can be tightly fitted to achieve firm fixation. In another alternative embodiment, the positioning portion 34 is disposed on the inflow end side of the connection portion 25, i.e., the positioning portion 34 climbs over the sealing stent 10, so that the sealing stent 10 provides radial supporting force at the inflow end of the valve ring 400 and the outflow end of the valve ring 400 simultaneously, to obtain a better sealing effect and reduce blood leakage.

As shown in fig. 2 and 9, in order to realize the cooperation between the fixing support 20 and the conveying system, the outflow end of the fixing portion 22 is provided with a second hanging tab 23, and the second hanging tab 23 is in limit cooperation with a second hook connection structure 700 of the conveying system. The shape of the second suspension loop 23 is complementary to the shape of the second hooking structure 700 of the delivery system used to implant the valve stent 100, and by this complementary fit in shape and the binding of the externally applied delivery system, the fixation of the compressed valve stent 100 within the delivery system can be achieved. When the valve prosthesis 1000 is released, the anchoring bar 31 is transformed from the first state mode to the second state mode and from the second state mode to the third state mode with respect to the two connecting bars 32 connected. In the process of switching from the second state mode to the third state mode, the valve stent 100 is released from the restraint of the delivery system, and returns to the expanded state under the action of the self-deformation force, i.e., the second hanging lugs 23 are also separated from the limit fit state of the delivery system under the action of the self-deformation force, so that the valve stent is separated from the delivery system.

As shown in fig. 5, when the anchor rod 31 is in the second state mode or the third state mode with respect to the two connecting rods 32 connected, the anchor rod 31 and the two connecting rods 32 connected form a plane inclined at an angle α, which satisfies the relationship: alpha is less than or equal to 90 degrees. The angle α may be, for example, 45 °,65 °,70 °, 75 °, or the like. At the same time, the length L is designed to ensure proper positioning of the positioning portion 34 and to reduce the length of the sealing stent 10 under the annulus 400 to reduce the effect of excessive penetration of the valve stent 100 into the left ventricle and thus blockage of the atrioventricular conduction bundle, so that the ratio of length L to length H is preferably in the range of 1/10-10/1, and preferably the ratio of length L to length H is in the range of 2/5-35/6.

As shown in fig. 8, the fixing support 20 and the sealing support 10 are designed to be a unique totally-enclosed grid, and the fixing support 20 and the sealing support 10 are connected through a second grid rod 24. The design of the totally-enclosed grid can avoid tissue damage caused by uneven stress distribution of tissues due to blank design or isolated grid design on one hand, and is convenient for complete recovery on the other hand; at the same time, it is also ensured that the second leaflet 500 is fully expanded, so that the valve prosthesis 1000 is tightly fitted with the aortic root, thereby achieving a better sealing effect and avoiding the leakage of surrounding tissue.

As shown in fig. 8, the seal holder 10 includes: a plurality of first grid bars 11. The plurality of first mesh bars 11 are arranged and connected in an array manner in the circumferential direction to form a support frame having a cylindrical or conical profile for sewing the skirt 300 and providing a support frame for the opening and closing movement of the fixing bracket 20 and the anchoring bracket 30. Specifically, the sealing support 10 is a grid unit of a circumferential array, and may be in a diamond grid structure, or may be in a hexagonal or other polygonal structure. The sealing stent 10 is implanted at the outflow ends of the annulus 400 and the left ventricle, the annulus 400 is spread by a circumferential structure, and is anchored at the outflow ends of the annulus 400 and the left ventricle by means of radial support force, thereby enhancing the fixation force of the valve prosthesis 1000.

In order to secure the supporting force of the seal holder 10, the width of the first mesh rod 11 should be preferably not less than 0.15mm, and the rod thickness of the first mesh rod 11 should be preferably not less than 0.2 mm. Meanwhile, since the inflow end of the sealing stent 10 is anchored in the outflow end of the left chamber, the dimension of the sealing stent 10 in the axial direction should be less than 15mm, thereby reducing left chamber conduction block caused by the inflow channel of the sealing stent 10 pressing against the atrioventricular node.

As shown in fig. 1, skirt 300 is secured to seal holder 10. The skirt 300 may be made of a polyester material, preferably polyethylene terephthalate (PET), polyurethane, or the like. The skirt 300 may be sewn integrally with the first leaflet 200 and the sealing stent 10 by sewing, preventing blood from leaking from the slits of the mesh of the valve prosthesis 1000, thereby ensuring good hemodynamics. Meanwhile, the microporous structure on the fabric surface of the skirt 300 is more beneficial to climbing of endothelial cells of a human body, accelerating endothelialization of a product, facilitating long-term fixation of the valve prosthesis 1000 and improving thrombus condition of the valve prosthesis 1000. Alternatively, skirt 300 may be made of Polytetrafluoroethylene (PTFE) or the like, and attached to valve holder 100 by sewing or heat staking.

The valve stent 100 may be a structure integrally cut from a portion of a tube, including the anchor stent 30, the fixing stent 20, and the sealing stent 10, i.e., the anchor stent 30, the sealing stent 10, and the fixing stent 20 of the valve stent 100 may be integrally formed.

The material of the valve stent 100 is preferably a shape memory alloy material, such as a nickel titanium alloy material, which is utilized to realize the deformation and pre-deformation functions of the valve stent 100 by utilizing the unique shape memory function and super-elastic function thereof; cobalt-chromium alloy, stainless steel, titanium alloy and other materials with better biocompatibility and elasticity can also be used. The complete stent structure may be cut from a relatively large diameter tube by laser cutting, followed by suitable heat and qualitative processing to allow the valve stent 100 to transition from a contracted state prior to implantation to an expanded state at the implantation site. The heat treatment and characterization process ensures specific dimensions of the valve stent 100 after implantation.

As shown in fig. 2 and 3, according to one embodiment of the present invention, the valve stent 100 is an expandable stent, i.e., the valve stent 100 may be deformed from a compressed state (refer to fig. 3) to a preset expanded state (refer to fig. 2). In use, the valve stent 100 is compressed into a delivery system, maintained in a compressed state, and delivered transvascularly into a patient's heart by the delivery system in a minimally invasive manner, during insertion, the valve stent 100 is in a compressed state along with the first leaflet 200, but the first leaflet 200 is not shown in the illustration for simplicity. When reaching the implantation site of the heart of the patient, the delivery system is withdrawn, the valve stent 100 loses the external constraint, and returns to the preset expanded state under the action of the self-deformation force, and the first leaflet 200 also expands as the valve stent 100 expands. The expanded state of the valve stent 100 is not necessarily exactly the same as the expanded state outside the body under the force of the perivalvular tissue.

According to the design of the present invention, the valve stent 100 may be self-expanding or may be expanded by auxiliary tools. The valve prosthesis 1000 can be implanted through a blood vessel and radially expanded after reaching a target site, and the valve prosthesis 1000 can be implanted in a patient's diseased valve site, such as an aortic valve or a pulmonary valve, by minimally invasive means, such as transapical or transfemoral means, and the like. The present invention is not limited to the manner in which the valve prosthesis 1000 is implanted, and implantation of the valve prosthesis 1000 may be accomplished in a variety of access manners, preferably through the thigh or through the apex of the heart.

A valve prosthesis 1000 system according to an embodiment of the second aspect of the invention, comprising: valve prosthesis 1000 and a delivery assembly. The valve prosthesis 1000 includes: a first leaflet 200, skirt 300, and valve stent 100; the conveying assembly comprises: a delivery body having a delivery lumen disposed therein for loading and delivering the valve prosthesis 1000.

The implantation process of the valve prosthesis 1000 of an embodiment of the present invention is described in connection with fig. 10 and 11.

First, the valve prosthesis 1000 is passed through the delivery system into the valve implantation site of the patient, at which time the valve prosthesis 1000 has not been released from the delivery system, the anchoring bar 31 is in a first state mode with respect to the two connected connecting bars 32, the valve stent 100 is in a compressed state, and the anchoring bar 31 and the two connected connecting bars 32 are both on the circumferential surface of the valve stent 100.

The middle region of the valve prosthesis 1000 is then first released, at which time the anchoring bars 31 are in the second state mode with respect to the two connecting bars 32 connected. The positioning portion 34 at the inflow end of the anchoring rod 31 is a free end, the positioning portion 34 end of the anchoring rod 31 is released first, and the first hanging tab 35 end of the anchoring rod 31 is not released, i.e. only one end of the anchoring rod 31 is restrained at this time, the positioning portion 34 end of the anchoring rod 31 is opened under the leverage and the pushing force generated by the position change of the connecting rod 32, and the maximum opening size of the anchoring rod 31 is realized under the cooperation of the conveying system, i.e. the maximum opening size of the anchoring rod 31 should be larger than the maximum opening size of the valve annulus 400, so that the effective capturing of the second valve leaflet 500 is realized under the condition that the second valve leaflet 500 is not stopped and opened and closed, and the aortic sinus is smoothly entered. Specifically, the expansion of the anchoring bar 31 causes the plane formed by the anchoring bar 31 and the two connecting bars 32 connected thereto to be inclined relatively, so that a certain space is formed between the anchoring bar 31 and the two connecting bars 32, and the second leaflet 500 can be fittingly received in the space.

Next, the shape of the valve prosthesis 1000 is determined by the reference mark on the positioning portion 34, the rotation angle of the valve prosthesis 1000 is adjusted such that the anchoring bar 31 is placed between the second leaflet 500 and the annulus 400, and two connecting bars 32 connected to the anchoring bar 31 are opposite to each other on the other side of the second leaflet 500 while pushing the valve prosthesis 1000 to push the positioning portion 34 of the anchoring bar 31 against the sinus floor, thereby determining the release position of the valve prosthesis 1000.

Further, the inflow and outflow ends of the valve prosthesis 1000 are released by the delivery system such that the valve prosthesis 1000 is fully released, at which time the anchoring bars 31 are in a third state mode with respect to the connected two connecting bars 32. Specifically, the valve stent 100 is not constrained by the delivery system and returns to the fully expanded state under the force of its own deformation. The sealing stent 10 struts the annulus 400 forming a circular channel; the anchoring stent 30 tightly holds the second leaflet 500; the first leaflet 200 on the fixed stent 20 works in place of the second leaflet 500 to firmly anchor the valve prosthesis 1000 in the heart valve position, completing implantation of the valve prosthesis 1000.

As shown in fig. 12 and 13, a valve stent 100 prepared according to another embodiment of the present invention. The number of the anchoring rods 31 can be one or more, at least two connecting rods 32 are provided, inflow ends of the two connecting rods 32 connected with the anchoring rods 31 are connected with the sealing support 10, outflow ends of the two connecting rods 32 intersect at a fulcrum, and the anchoring rods 31 are connected with the fulcrum. In addition, other aspects of the design of the valve stent 100 of this embodiment are described with reference to the valve stent 100 of the above-described embodiments. The valve stent 100 of this embodiment can obtain the same advantageous effects as the valve stent 100 described in the above-described embodiments.

In the description of the present invention, it should be understood that the terms "length," "width," "thickness," "upper," "lower," "inner," "outer," "axial," "radial," "circumferential," and the like indicate or are based on the orientation or positional relationship shown in the drawings, merely to facilitate description of the present invention and simplify description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be configured and operated in a particular orientation, and thus should not be construed as limiting the present invention.

In the description of the present specification, reference to the terms "one embodiment," "some embodiments," "illustrative embodiments," "examples," "specific examples," or "some examples," etc., means that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the invention. In this specification, schematic representations of the above terms do not necessarily refer to the same embodiments or examples.

While embodiments of the present invention have been shown and described, it will be understood by those of ordinary skill in the art that: many changes, modifications, substitutions and variations may be made to the embodiments without departing from the spirit and principles of the invention, the scope of which is defined by the claims and their equivalents.

Claims

1. A valve stent, comprising:

the sealing support is used for being matched with the valve ring;

The fixing support is arranged at the outflow end of the sealing support and is used for fixing the first valve leaflet;

The anchor support, the anchor support set up in the outflow end of seal support, the anchor support includes anchor pole and connecting rod, the anchor pole is connected in two the junction of connecting rod, the anchor pole has three kinds of state modes for two that link to each other the connecting rod: in a first state mode, the anchoring rod and the two connected connecting rods are arranged on the circumferential surface of the valve bracket; in a second state mode, the plane formed by the anchoring rod and the two connected connecting rods is inclined relatively so as to leave a space for accommodating the second valve leaflet and be used for capturing the second valve leaflet; in the third state mode, the plane formed by the anchoring rod and the two connected connecting rods is inclined relatively, and the inclination included angle is smaller than that of the second state mode, so that a space for accommodating the second valve leaflet is reserved for clamping the second valve leaflet.

2. The valve stent of claim 1, wherein at least two of the connecting rods intersect at a fulcrum at the outflow ends of the two connecting rods, the anchoring rod is connected with the fulcrum, and the anchoring rod is arranged along the axial direction of the valve stent; the inflow ends of the two connecting rods are respectively connected with the two adjacent fixed brackets; or alternatively

The inflow ends of the two connecting rods are connected with the sealing support.

3. The valve stent according to claim 1 or 2, wherein the inflow end of the anchoring rod is provided with a positioning part, the length from the intersecting fulcrum of the two connecting rods to the positioning part is H, and the length of the connecting rod is L; the ratio of the length H to the dimension of the second leaflet in the axial direction when the second leaflet is fully open is in the range of 1/10-2/1;

and/or the ratio of said length L to said length H is in the range of 1/10 to 10/1;

Or the H satisfies the relation: 6 mm.ltoreq.H.ltoreq.20mm, and/or the L satisfies the relation: l is more than or equal to 8mm and less than or equal to 35mm.

4. The valve stent of claim 3, wherein the positioning portion is configured as one or a combination of a sphere, a quasi-circle, an arc, or a drop; or the outer surface of the positioning part is provided with a buffer piece, and the buffer piece adopts a buffer material.

5. A valve holder according to claim 3, wherein the positioning portion is provided with reference marks for displaying positions under observation of an infrared or ultrasonic developing device or the like.

6. The valve stent of claim 3, wherein a first hanging ring is arranged at the outflow end of the anchoring rod, the first hanging ring is in limit fit with a first hooking structure of a conveying system, the length from a fulcrum intersected by two connecting rods to the first hanging ring is H, and the ratio of the length H to the length H is in the range of 1/20-2/1; or the h satisfies the relation: h is more than or equal to 2mm and less than or equal to 8mm.

7. A valve holder according to claim 3, wherein the perpendicular distance of the positioning portion to the outer surface of the valve holder is D, the ratio of the distance D to the radius of the annulus being in the range of 1/2-2/1, when the anchoring rod is in the second state mode with respect to the two connecting rods connected.

8. A valve holder according to claim 3, wherein a connecting portion is provided between two adjacent fixing holders, and the positioning portion is located on an outflow end side of the connecting portion or on an inflow end side of the connecting portion.

9. The valve stent of claim 1, wherein when the anchoring rod is in the second state mode or the third state mode relative to the two connected connecting rods, the anchoring rod forms an angle α with the connecting rods that satisfies the relationship: alpha is less than or equal to 90 degrees.

10. A valve prosthesis system, comprising:

a valve prosthesis, the valve prosthesis comprising: a first leaflet, a skirt, and the valve stent of any one of claims 1-9, the first leaflet and the skirt disposed on the valve stent;

a delivery assembly, the delivery assembly comprising: a delivery body having a delivery lumen disposed therein for loading and delivering the valve prosthesis.