CN114569293B

CN114569293B - Prosthetic valve and transcatheter prosthetic valve delivery system

Info

Publication number: CN114569293B
Application number: CN202210496321.XA
Authority: CN
Inventors: 王海山; 朱洪旺; 虞奇峰; 秦涛
Original assignee: Shanghai Newpulse Medical Technology Co ltd
Current assignee: Shanghai Newpulse Medical Technology Co ltd
Priority date: 2022-05-09
Filing date: 2022-05-09
Publication date: 2022-09-20
Anticipated expiration: 2042-05-09
Also published as: CN114569293A

Abstract

The invention discloses a prosthetic valve and a transcatheter prosthetic valve delivery system, the prosthetic valve comprising: the valve stent comprises a stent main body and a first limiting piece, wherein the first limiting piece is arranged at the proximal end of the stent main body; the positioning frame comprises a positioning frame main body and a second limiting piece arranged on the positioning frame main body; the valve stent and the positioning frame are both provided with a radially compressed conveying state and a radially expanded implanting state, the positioning frame forms a positioning space around a native valve leaflet in the implanting state, and when the stent main body is expanded in the positioning space, the first limiting part is suitable for being connected to the second limiting part so as to limit the stent main body and the positioning frame main body. The valve support is suitable for being matched with the positioning frame, so that the valve support is simple in structure and convenient to install.

Description

Prosthetic valve and transcatheter prosthetic valve delivery system

Technical Field

The present invention relates to the medical field, and further relates to prosthetic valves and transcatheter prosthetic valve delivery systems.

Background

The heart is divided into left and right parts, each part including a ventricle and an atrium, the ventricle and atrium being separated by a ventricular septum and an atrial septum, with valves between the atrium, chamber and artery to prevent regurgitation of blood. The valve between the left atrium and the left ventricle is a mitral valve, the valve between the right atrium and the right ventricle is a tricuspid valve, the valve between the left ventricle and the aorta is an aortic valve, and the valve between the right ventricle and the pulmonary artery is a pulmonary valve.

The valves open and close in response to the contraction and relaxation of the heart, and therefore the valves of the heart must withstand prolonged flushing with blood and squeezing of the blood against the surrounding annulus. When the valve fails to close completely, which can lead to regurgitation of blood, physicians sometimes recommend placement of the valve stent by minimally invasive intervention in order to improve blood supply.

It should be noted that valve stents may be introduced into a patient using a catheter that is introduced into the femoral artery or heart through a small incision, and that one of the major problems in heart valve delivery is the positioning of the prosthetic heart valve within a small area, such as 2-5mm, of the target area. Physicians have tried different methods to confirm their judgment during heart valve delivery, including different marking systems, multiple contrast dye injections during the procedure, and adjustment of the examination angle in the imaging system. However, these methods and current imaging systems have limitations. For example, the standard error of current imaging systems is about 2mm, and operator manipulation introduces further variables. Further, the movement of the heart itself may cause the target landing area to shift by 2-5 mm. These problems make it difficult to precisely position the prosthetic valve.

Disclosure of Invention

In view of the above technical problems, it is an object of the present invention to provide a prosthetic valve and a transcatheter prosthetic valve delivery system, which are convenient in position adjustment of a valve stent and a positioning frame and can achieve accurate positioning.

In order to achieve the above object, the present invention provides a prosthetic valve comprising:

the valve stent comprises a stent main body and a first limiting piece, wherein the first limiting piece is arranged at the proximal end of the stent main body;

the positioning frame comprises a positioning frame main body and a second limiting piece arranged on the positioning frame main body;

the valve stent and the positioning frame are both provided with a radially compressed conveying state and a radially expanded implanting state, the positioning frame forms a positioning space around a native valve leaflet in the implanting state, and when the stent main body is expanded in the positioning space, the first limiting part is suitable for being connected to the second limiting part so as to limit the stent main body and the positioning frame main body.

In some preferred embodiments, the first stopper is a flexible cord having a developable property.

In some preferred embodiments, the flexible cord is deployed and disposed around the stent body when the stent body is in the implanted state.

In some preferred embodiments, the prosthetic valve further comprises a wire winding rod, a first end of the wire winding rod is connected to the stent main body, a second end of the wire winding rod extends outwards along the length direction of the stent main body, the second end is provided with a wire threading hole, and the first limiting member passes through the wire threading hole.

In some preferred embodiments, the second end of the winding rod extends obliquely outward along the length direction of the bracket main body, and a first included angle is formed between the bracket main body and the winding rod, and the first included angle ranges from 30 degrees to 60 degrees.

In some preferred embodiments, the first end is connected to the stent body at an intermediate position, the second end extends proximally, and the second end is a predetermined distance from the proximal end of the stent body.

In some preferred embodiments, the prosthetic valve further comprises a sealing membrane and a prosthetic leaflet mounted to the stent body.

In some preferred embodiments, the second limiting member is a hook having developing properties.

In some preferred embodiments, the catch is mounted to the inside of the spacer body and opens towards the proximal end of the spacer body.

In some preferred embodiments, the hook extends obliquely from the inner side of the spacer main body toward the center of the positioning space.

In some preferred embodiments, the hook includes a base rod, a fastening section, an abutting section and an outward turning section, which are connected in sequence, the base rod is connected to the positioning frame main body, the fastening section is bent to form a fastening space, the abutting section is bent towards the base rod, the outward turning section is bent towards a direction far away from the base rod, and a gap between the abutting section and the base rod is communicated with the fastening space.

In some preferred embodiments, the distal end of the spacer body has barbs extending proximally.

In some preferred embodiments, the positioning frame main body includes at least three elastic arms, each elastic arm includes a distal bending section and an extension rod extending from two ends of the distal bending section to a proximal end, and proximal ends of the extension rods adjacent to the elastic arms are integrally connected.

In some preferred embodiments, the valve stent and the positioning frame are both made of shape memory materials.

In some preferred embodiments, the stent body is cylindrical in the implanted state and comprises a plurality of interconnected stent units that surround and form a communication hole, the communication hole at the distal end of the stent body being smaller in size than the communication hole at the proximal end of the stent body.

In some preferred embodiments, the proximal ends of the valve stent and the positioning frame are provided with connectors for connecting with a delivery mechanism.

According to another aspect of the present invention, there is further provided a transcatheter prosthetic valve delivery system, comprising:

the prosthetic valve of any of the above;

a delivery catheter having a distal end adapted to mount the prosthetic valve;

a delivery control device coupled to the proximal end of the delivery catheter for controlling the movement of the prosthetic valve at the distal end of the delivery catheter.

In some preferred embodiments, the distal end of the delivery catheter is provided with a stent loading section and a positioning frame loading section in the axial direction, the stent loading section is used for installing a valve stent of the artificial valve, the positioning frame loading section is used for installing a positioning frame of the artificial valve, and the delivery control device is used for controlling the release of the valve stent and the positioning frame.

Compared with the prior art, the artificial valve and the transcatheter artificial valve delivery system provided by the invention have at least one of the following beneficial effects:

1. according to the artificial valve and the transcatheter artificial valve delivery system, the valve support is suitable for being matched with the positioning frame, the valve support and the positioning frame can be accurately positioned, and the position is convenient to adjust;

2. according to the artificial valve and the transcatheter artificial valve delivery system provided by the invention, the first limit piece of the valve stent is a flexible rope with developing property, so that the valve stent can be quickly connected with the second limit piece on the positioning frame and can be conveniently contracted;

3. according to the valve stent and the transcatheter valve prosthesis delivery system provided by the invention, the valve stent further comprises the winding rod which extends outwards along the length extension direction of the stent main body, and the connection with the second limit piece can be realized before the stent main body is not completely unfolded, so that the relative position of the valve stent and the positioning frame can be conveniently adjusted;

4. the positioning frame can be delivered to the heart valve of a patient in advance, and can effectively and accurately position the valve support;

5. the valve stent and positioning frame has a first shape suitable for delivery compressed in the delivery system and a second shape for expanding implantation at a human valve; in the delivery system, the valve stent and the positioning frame are separated from each other, so that the diameter of the delivery catheter can be reduced, and the valve stent and the positioning frame can conveniently enter a human body through a vascular path;

6. according to the artificial valve and the transcatheter artificial valve delivery system provided by the invention, the valve support and the positioning frame are relatively fixed after the implantation is completed, so that the relative positions between the positioning frame and the human valve and between the valve support and the positioning frame can be adjusted in the implantation process, and the positioning frame can be completely recovered before the positioning frame is completely released.

Drawings

The above features, technical features, advantages and modes of realisation of the present invention will be further described in the following detailed description of preferred embodiments thereof, which is to be read in connection with the accompanying drawings.

FIGS. 1 and 2 are perspective views of a preferred embodiment of the invention in an expanded state;

FIG. 3 is a perspective view of a contracted state of a valve stent of a preferred embodiment of the present invention;

FIG. 4 is a side view of a preferred embodiment valve stent of the present invention;

FIG. 5 is an enlarged view taken at a in FIG. 4;

FIG. 6 is a perspective view of another state of a preferred embodiment valve stent of the present invention;

FIG. 7 is a perspective view of the spacer of the preferred embodiment of the present invention in a deployed state;

FIG. 8 is a side view of the spacer of the preferred embodiment of the present invention;

FIG. 9 is a perspective view of the strongback of the preferred embodiment of the present invention in a retracted state;

FIG. 10 is an enlarged view at b in FIG. 8;

FIG. 11 is a top view of the spacer in a deployed state in accordance with a preferred embodiment of the present invention;

FIG. 12 is a schematic diagram of the overall construction of a transcatheter prosthetic valve delivery system according to a preferred embodiment of the present invention;

FIG. 13 is an enlarged structural view at c in FIG. 12;

FIG. 14 is a schematic structural view showing the combined state of the valve stent and the positioning frame according to the preferred embodiment of the present invention.

The reference numbers illustrate:

the valve stent comprises a valve stent 10, a stent main body 11, a connector 111, a stent unit 112, a first rod 1121, a second rod 1122, a third rod 1123, a fourth rod 1124, a first positioning rod 1125, a second positioning rod 1126, a first limiting member 12, an expanding state 101, a contracting state 102, a winding rod 13, a first end 131, a second end 132, a threading hole 130, an artificial valve leaflet 14, a sealing membrane 15, a positioning frame 20, a positioning frame main body 21, a positioning space 210, a connecting member 211, an elastic arm 212, a distal bending section 2121, an extending rod 2122, a second limiting member 22, a base rod 221, a fixing section 222, a clamping space 2220, an abutting section 223, an everting section 224, an expanding state 201, a retracting state 202, a barb 23, a delivery catheter 30, a stent loading section 31, a positioning frame loading section 32 and a delivery control device 40.

Detailed Description

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following description will be made with reference to the accompanying drawings. It is obvious that the drawings in the following description are only some examples of the invention, and that for a person skilled in the art, other drawings and embodiments can be derived from them without inventive effort.

For the sake of simplicity, only those parts relevant to the invention are schematically shown in the drawings, and they do not represent the actual structure as a product. In addition, in order to make the drawings concise and understandable, components having the same structure or function in some of the drawings are only schematically illustrated or only labeled. In this document, "a" means not only "only one of this but also a case of" more than one ".

It should be further understood that the term "and/or" as used in this specification and the appended claims refers to and includes any and all possible combinations of one or more of the associated listed items.

In this context, it is to be understood that, unless otherwise explicitly stated or limited, the terms "mounted," "connected," and "connected" are to be construed broadly and may include, for example, a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

In addition, in the description of the present application, the terms "first", "second", and the like are used only for distinguishing the description, and are not intended to indicate or imply relative importance.

Referring to fig. 1-14, the present invention provides a prosthetic valve and transcatheter prosthetic valve delivery system. The artificial valve comprises a valve stent 10 and a positioning frame 20. The positioning frame 20 is suitable for being placed at the heart valve of a patient, the valve support 10 is suitable for being placed in the internal positioning space of the deployed positioning frame 20, and the positioning frame 20 is fixedly connected with the valve support 10 so as to fix the relative position between the valve support 10 and the positioning frame 20. The valve stent 10 and the positioning frame 20 both have a radially compressed delivery state and a radially expanded implantation state, and the positioning frame 20 forms a positioning space around native valve leaflets when in the implantation state.

Taking the aortic valve implantation process as an example, in the implantation process, the positioning frame 20 is firstly delivered to a release position through a catheter artificial valve delivery system, the delivery system is operated to expose the positioning frame 20, and the positioning frame 20 is fixed in the sinus of the cardiac valve, and the positioning frame 20 forms a positioning space around when in a deployed state; and then releasing the valve stent 10 in the positioning space of the positioning frame 20, fixing the valve stent 10 and the positioning frame 20 relatively, and expanding the valve stent 10 to the expanded state, so that the native valve leaflets are clamped between the positioning frame 20 and the valve stent 10. In the process of releasing the positioning frame 20 and the valve stent 10, the relative position between the positioning frame 20 and the human valve and the relative position between the valve stent 10 and the positioning frame 20 can be adjusted in due time according to actual needs. After ensuring that there is no error, the spacer 20, the valve stent 10, and the delivery system are disengaged and the delivery device is removed from the patient.

Referring to fig. 1, 2, 4 and 6, in particular, the valve stent 10 provided by the present invention includes a stent main body 11 and a first stopper 12. The proximal end of the stent body 11 has a number of connectors 111 for connection to a delivery mechanism by which the valve stent 10 can be delivered to the heart valve of a patient. The valve stent 10 has an expanded state 101 (i.e., an implanted state) and a contracted state 102 (i.e., a delivery state).

Referring to fig. 7 and 11, the spacer 20 includes a spacer main body 21 and a second stopper 22. The second stopper 22 is attached to the spacer body 21. The positioning frame 20 has a deployed state 201 (i.e., implanted state) and a retracted state 202 (i.e., delivery state), see fig. 7 and 9. When the positioning frame 20 is in the unfolding state 201, the positioning frame main body 21 surrounds and forms a positioning space 210, and the valve stent 10 is suitable to be placed in the positioning space 210. When the valve stent 10 is placed in the positioning space 210, the first retaining member 12 and the second retaining member 22 are connected and matched with each other to fix the relative position relationship between the valve stent 10 and the positioning frame 20, so as to achieve the purpose of positioning the valve stent 10.

The spacer 20 further includes a connector 211 mounted to the proximal end of the spacer body 21 for connection to a delivery mechanism by which the spacer 20 can be delivered to the heart valve of the patient.

It should be noted that in the preferred embodiment, the proximal end of the valve stent 10 and the proximal end of the positioning frame 20 respectively refer to the end that enters the human body after the intervention, and the distal end of the valve stent 10 and the distal end of the positioning frame 20 respectively refer to the end that enters the human body before the intervention.

Referring to fig. 1, 2, 4, 5 and 6, in some embodiments, the first limiting member 12 is a flexible rope with developing properties. Referring to fig. 7, 8 and 10, the second stopper 22 is a hook having developing properties. When the valve support 10 is installed in the positioning space 210 of the positioning frame 20, the hooks hook the flexible ropes to fix the relative position between the valve support 10 and the positioning frame 20.

Alternatively, the positions of the flexible cord and the hook can also be interchanged, i.e. the first retaining member 12 is a hook and the second retaining member 22 is a flexible cord.

In some embodiments, the flexible cord is made of a nylon material. Alternatively, the flexible cord can also be a flexible metal strip. It will be appreciated that the particular type of flexible cord should not be construed as limiting the invention.

The first limiting member 12 implemented as a flexible rope further includes a metal positioning wire wound with the flexible rope, so that the first limiting member 12 has a developing function, and an operator can conveniently determine the position of the valve stent 10. In some embodiments, the metal positioning wire is a platinum iridium wire, and the flexible cord and the platinum iridium wire are wound to form the first retaining member 12.

The surface of the inlet portion of the second limiting member 22 implemented as a hook is coated with a platinum-iridium alloy coating to facilitate the operator to determine the position of the second limiting member 22 implemented as a hook.

In the process of installing the valve stent 10 and the positioning frame 20, an operator can accurately determine the positions of the first limiting member 12 and the second limiting member 22, which is helpful for the first limiting member 12 and the second limiting member 22 to be accurately matched to achieve accurate positioning.

In some embodiments, the flexible cord is deployed and disposed around the stent body 11 when the stent body 11 is in the expanded state 101. In some embodiments, the flexible cord is looped around the outside of the stent body 11 when the stent body 11 is in the expanded state 101. It will be understood that the relative positional relationship between the flexible cord and the stent body 11 should not be construed as limiting the invention.

In some embodiments, the first restraint 12 implemented as a flexible cord is a complete flexible restraint cord. Alternatively, the first limiting member 12 implemented as a flexible cord can also be formed by a plurality of intermittently arranged short cords. The particular form of the first retaining member 12 embodied as a flexible cord should not constitute a limitation of the present invention.

Referring to fig. 4, 5 and 6, the valve stent 10 further includes a wire winding rod 13. The first end 131 of the winding rod 13 is connected to the bracket body 11, the second end 132 of the winding rod 13 extends outwards along the length direction of the bracket body 11, the second end 132 is provided with a threading hole 130, and the first limiting member 12 passes through the threading hole 130.

The second end 132 of the winding rod 13 extends obliquely outwards along the length direction of the bracket main body 11, and a first included angle is formed between the bracket main body 11 and the winding rod 13, and the range of the first included angle is 30-60 degrees. Preferably, the second end 132 of the winding rod 13 extends obliquely outward along the bracket main body 11 at an angle of 45 °. The second end 132 of the winding rod 13 extends obliquely outward in an expanded state, so that the first limiting member 12 can surround the outer side of the bracket main body 11, and the first limiting member 12 is conveniently connected to the second limiting member 22 on the positioning frame 20.

In some embodiments, the first end 131 of the winding rod 13 is connected to the middle of the bracket body 11, and the second end 132 extends toward the proximal end of the bracket body 11. Alternatively, the first end 131 of the winding rod 13 is connected to the proximal end of the bracket body 11, the second end 132 extends towards the distal end of the bracket body 11, and the second end 132 is spaced from the proximal end of the bracket body 11 by a predetermined distance, and the proximal end of the bracket body 11 is disposed to protrude from the second end 132 of the winding rod 13. By providing a predetermined distance between the second end 132 and the proximal end of the stent body 11, it is convenient for the stent body 11 to be assembled with the positioning frame 20 before being released.

Optionally, in some variant embodiments, the valve stent 10 is not provided with a wire winding rod 13, the preset position of the valve stent 10 has a perforation, and the first retaining member 12 implemented as a flexible rope passes through the perforation of the valve stent 10 to fixedly mount the first retaining member 12 to the valve stent 10. In other modified embodiments, the wire winding rod 13 and the first limiting member 12 are omitted, and the first limiting member 12 only includes the hook mounted on the valve holder 10.

Referring to fig. 5, in some embodiments, the stent body 11 includes a plurality of stent units 112 connected in series and capable of telescoping. The stent unit 112 includes a first rod 1121, a second rod 1122, a third rod 1123, and a fourth rod 1124, the first rod 1121, the second rod 1122, the third rod 1123, and the fourth rod 1124 are sequentially connected end to end, and form a substantially diamond shape in an expanded state. The stent main body 11 has a cylindrical shape in an implanted state, and the stent unit 10 surrounds and forms communication holes, the size of which is smaller at the distal end of the stent main body 11 than at the proximal end of the stent main body 11.

Referring to fig. 5, the ring of stent units 112 near the proximal end of the stent body 11 further includes a first locating rod 1125 and a second locating rod 1126. One end of the first positioning rod 1125 is connected to the first rod 1121, and the other end thereof is connected to the fourth rod 1124; the second positioning rod 1126 has one end connected to the second rod 1122 and the other end connected to the third rod 1123.

In some embodiments, the first end 131 of the wire winding rod 13 is connected to the connection of the first rod 1121 and the second rod 1122.

In some embodiments, the catch is mounted to the inside of the spacer body 21 and opens toward the proximal end of the spacer body 21. In the process of installing the valve stent 10 into the positioning space 210 of the positioning frame main body 21, the first limiting member 12 implemented as a flexible rope automatically moves into the hook space of the second limiting member 22 implemented as a hook, so as to assemble the first limiting member 12 and the second limiting member 22. The hook preferably extends obliquely from the inner side of the positioning frame main body 21 to the center of the positioning space 210, so that the hook is connected with the first stopper 12 of the valve holder 10 installed in the positioning space 210.

Alternatively, in a modified embodiment, the hook is mounted inside the spacer main body 21 and opens toward the distal end of the spacer main body 21. In the process of installing the valve stent 10 into the positioning space 210 of the positioning frame main body 21, the first limiting member 12 of the valve stent 10 is pushed to pass over the second limiting member 22 of the positioning frame 20, and then the valve stent 10 is pulled back outwards, so that the first limiting member 12 is in contact with the second limiting member 22, and the valve stent 10 is separated from the delivery device while the relative position between the valve stent 10 and the positioning frame 20 is fixed.

Referring to fig. 10, the second retaining member 22 implemented as a hook includes a base rod 221, a fastening section 222, an abutting section 223, and an everting section 224 connected in sequence. The base rod 221 is connected to the positioning frame main body 21, the clamping section 222 is bent to form a clamping space 2220, the abutting section 223 is bent towards the direction of the base rod 221, the outward turning section 224 is bent towards the direction far away from the base rod 221, and the gap between the abutting section 223 and the base rod 221 is communicated with the clamping space 2220.

It is noted that the everting section 224 has a first distance from the base shaft 221 and the abutment section 223 has a second distance from the base shaft 221, the first distance being greater than the second distance. In the process of mutually mounting and fixing the valve stent 10 and the positioning frame 20, the first retaining member 12 implemented as a flexible rope is moved into between the everting section 224 and the base rod 221, and then enters the clamping space 2220 through the gap between the abutting section 223 and the base rod 221 along the everting section 224 and the abutting end 223. The outward turning segment 224 turned outward relative to the base shaft 221 can facilitate the movement of the first position-limiting member 12 into the fastening space 2220.

In some embodiments, the distal end of the retainer body 21 has proximally extending barbs 23, and the barbs 23 are used to prevent the retainer body 21 from being dislocated and improve the stability of the retainer 20.

Referring to fig. 7 and 8, the positioning frame main body 21 includes at least three elastic arms 212, each elastic arm 212 includes a distal bent segment 2121 and an extension rod 2122 extending from both ends of the distal bent segment 2121 to the proximal end, and the proximal ends of the extension rods 2122 of adjacent elastic arms 212 are integrally connected.

The valve stent 10 further includes a prosthetic leaflet 14 mounted to the stent body 11 and a sealing membrane 15.

In some embodiments, the stent body 11 and the stent body 21 are made of nitinol material, respectively. In some embodiments, the valve stent 10 and the positioning frame 20 are made of a shape memory material.

Referring to fig. 12, according to another aspect of the present invention, the present invention further provides a transcatheter prosthetic valve delivery system comprising: the prosthetic valve, delivery catheter 30, and delivery control device 40 of any of the above. Referring to fig. 14, the distal end of the delivery catheter 30 is adapted to mount the prosthetic valve; a delivery control device 40 is attached to the proximal end of the delivery catheter 30 for controlling the implantation of the prosthetic valve at the distal end of the delivery catheter 30.

Referring to fig. 13, a stent loading section 31 and a positioning frame loading section 32 are arranged in the axial direction of the distal end of the delivery catheter 30, the stent loading section 31 is used for installing the valve stent 10 of the artificial valve, the positioning frame loading section 32 is used for installing the positioning frame 20 of the artificial valve, and the delivery control device 40 is used for controlling the release of the valve stent 10 and the positioning frame 20. During the implantation process, the operator operates the delivery control device 40 to adjust the positioning frame loading section 32 to a preset position, adjust the positioning frame 20 to the preset position and switch to the expanded state 201, since the connecting member 211 of the positioning frame 20 is not yet disengaged from the delivery system, if the release position of the positioning frame 20 is found to be not ideal, the positioning frame 20 can be gradually compressed from the connecting member 211 by moving the delivery catheter 30 to the far end, and the positioning frame 20 can be completely retracted into the delivery catheter 30. The delivery control device 40 is then operated again to adjust the stent loading section 31 to the appropriate position, and switched to the expanded state 101 and connected to the stent 20, and then the delivery control device 40 is operated to release the valve stent 10 and the stent 20.

It should be noted that the valve holder 10 and the positioning frame 20 of the prosthetic valve provided by the preferred embodiment can be accurately positioned in the body and assembled quickly. Prior to implantation, the valve stent 10 is in the contracted state 102, the positioning frame 20 is in the retracted state 202, and the valve stent 10 and the positioning frame 20 are spaced apart from each other on the delivery catheter 30, which reduces the radial dimension of the delivery catheter 30 to facilitate passage through a blood vessel or the like into the body. On the other hand, before the valve stent 10 and the positioning frame 20 are completely released, the operator can adjust the positions of the valve stent 10 and the positioning frame 20 at any time, and can completely recover the positioning frame 20 before the positioning frame 20 is completely released.

It should be noted that the above embodiments can be freely combined as necessary. The foregoing is only a preferred embodiment of the present invention, and it should be noted that it is obvious to those skilled in the art that various modifications and improvements can be made without departing from the principle of the present invention, and these modifications and improvements should also be considered as the protection scope of the present invention.

Claims

1. A prosthetic valve having a proximal end distal to an apex location and a distal end proximal to the apex location, comprising: the valve stent comprises a stent main body and a first limiting piece, wherein the first limiting piece is arranged at the proximal end of the stent main body; the positioning frame comprises a positioning frame main body and a second limiting piece arranged at the near end of the positioning frame main body; the valve stent and the positioning frame are both provided with a radially compressed delivery state and a radially expanded implantation state, the positioning frame forms a positioning space around native valve leaflets when in the implantation state, and when the stent main body is expanded in the positioning space, the first limiting part is suitable for being connected to the second limiting part so as to limit the stent main body and the positioning frame main body;

the first limiting part is a flexible rope with developing property.

2. The prosthetic valve of claim 1, wherein the flexible cord is deployed and disposed around the stent body when the stent body is in the implanted state.

3. The prosthetic valve of claim 2, further comprising a wire rod having a first end connected to the stent body and a second end extending outwardly along the length of the stent body, the second end having a threading hole through which the first retaining member passes.

4. The prosthetic valve of claim 3, wherein the second end of the wire wrapping rod extends obliquely outward along a length of the stent body, the stent body and the wire wrapping rod forming a first included angle therebetween, the first included angle ranging from 30 ° to 60 °.

5. The prosthetic valve of claim 4, wherein the first end is coupled to the stent body at an intermediate location, the second end extends proximally, and the second end is a predetermined distance from the proximal end of the stent body.

6. The prosthetic valve of any one of claims 1-5, further comprising a sealing membrane and prosthetic leaflet mounted to the stent body.

7. The prosthetic valve of claim 6, wherein the second stop is a hook with visualization properties.

8. The prosthetic valve of claim 7, wherein the catch is mounted to an inside of the spacer body and opens toward a proximal end of the spacer body.

9. The prosthetic valve of claim 8, wherein the hook extends obliquely from an inner side of the stent body toward a center of the positioning space.

10. The prosthetic valve of claim 8, wherein the hook comprises a base rod, a fastening section, an abutting section and an outward turning section, which are connected in sequence, the base rod is connected to the positioning frame main body, the fastening section is bent to form a fastening space, the abutting section is bent towards the base rod, the outward turning section is bent away from the base rod, and a gap between the abutting section and the base rod is communicated with the fastening space.

11. The prosthetic valve of claim 10, wherein the distal end of the spacer body has proximally extending barbs.

12. The prosthetic valve of claim 10, wherein the positioning frame body comprises at least three elastic arms, the elastic arms comprise a distal bending section and an extension rod extending from two ends of the distal bending section to a proximal end, and proximal ends of the extension rods adjacent to the elastic arms are integrally connected.

13. The prosthetic valve of any of claims 7-12, wherein the valve holder and the positioning frame are both made of a shape memory material.

14. The prosthetic valve of claim 13, wherein the stent body is cylindrical in the implanted state and comprises a plurality of interconnected stent units that circumscribe a communication aperture, the communication aperture at a distal end of the stent body being smaller in size than the communication aperture at a proximal end of the stent body.

15. The prosthetic valve of claim 13, wherein the proximal ends of the valve holder and the positioning frame are each provided with a connector for connecting a delivery mechanism.

16. A transcatheter prosthetic valve delivery system, comprising: the prosthetic valve of any one of claims 1-15; a delivery catheter having a distal end adapted to mount the prosthetic valve; a delivery control device coupled to the proximal end of the delivery catheter for controlling the movement of the prosthetic valve at the distal end of the delivery catheter.

17. The transcatheter prosthetic valve delivery system of claim 16, wherein the distal end of the delivery catheter is axially configured with a stent loading section for mounting a valve stent of the prosthetic valve and a stent loading section for mounting a stent of the prosthetic valve, and the delivery control device is configured to control release of the valve stent and the stent.