CN114886614A - Prosthetic valve and transcatheter prosthetic valve delivery system - Google Patents

Abstract

The invention discloses a prosthetic valve and a transcatheter prosthetic valve delivery system, wherein the prosthetic valve comprises a valve stent; a positioning frame; the connecting assembly comprises a first connecting piece and a second connecting piece, the first connecting piece is connected to the valve support, the second connecting piece is connected to the positioning frame, and the first connecting piece is connected to the second connecting piece in a sliding mode; the valve stent and the positioning frame are both provided with a radially compressed delivery state and a radially expanded implantation state, and the positioning frame can form a positioning space around the native valve leaflets; at least one part of the valve support is suitable for entering the positioning space when the positioning frame is in an implantation state and driving the first connecting piece to slide relative to the second connecting piece, at least one part of the valve support can be unfolded in the positioning space to be in the implantation state, and the valve support and the positioning frame can be positioned by virtue of the connecting assembly. The valve support and the positioning frame of the artificial valve are in sliding connection through the first connecting piece and the second connecting piece, and the valve support and the positioning frame can be effectively positioned in the implantation process.

Description

Prosthetic valve and transcatheter prosthetic valve delivery system

Technical Field

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

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 aforementioned 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 and 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.

At present, the problems of inaccurate positioning, low release precision and poor positioning stability exist in the implantation process of the valve stent, and the use effect of the valve stent is influenced.

Disclosure of Invention

In view of the above technical problems, an object of the present invention is to provide a prosthetic valve and a transcatheter prosthetic valve delivery system, in which a valve stent and a positioning frame of the prosthetic valve are slidably connected by a first connecting member and a second connecting member, and the valve stent and the positioning frame can be effectively positioned during implantation.

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

a valve stent;

the positioning frame comprises at least three elastic arms, each elastic arm comprises a near-end bending section and an extension rod extending from two ends of the near-end bending section to a far end, and the near ends of the extension rods of the adjacent elastic arms are integrally connected;

the connecting assembly comprises a first connecting piece and a second connecting piece, the first connecting piece is connected to the valve support, the second connecting piece is connected to the positioning frame, the first connecting piece is connected to the second connecting piece in a sliding mode, and the connecting assembly further comprises a one-way limiting structure arranged between the first connecting piece and the second connecting piece;

the valve stent and the positioning frame are both provided with a radial compressed delivery state and a radial expanded implantation state, and the positioning frame can form a positioning space around native valve leaflets when in the implantation state;

at least one part of the valve support is suitable for entering the positioning space when the positioning frame is in the implantation state and driving the first connecting piece to slide relative to the second connecting piece, at least one part of the valve support can be unfolded in the positioning space to be in the implantation state, the valve support and the positioning frame can be positioned by virtue of the connecting assembly, and when the at least one part of the valve support moves in the direction leaving the positioning space, the one-way limiting structure can limit the first connecting piece and the second connecting piece to slide relatively so as to limit the at least one part of the valve support to leave the positioning space.

In some preferred embodiments, the second connector is a guide rod, a proximal end of the guide rod is connected to a proximal end of the positioning frame, a distal end of the guide rod extends towards a distal end of the positioning frame, and the first connector is slidably connected to the guide rod.

In some preferred embodiments, the first link has a slide channel, and the guide bar is slidably mounted to the slide channel.

In some preferred embodiments, the first connecting member is a connecting string, one end of the connecting string is fixed to the proximal end of the valve holder, and one end of the connecting string, which is far away from the valve holder, is knotted to form the sliding channel.

In some preferred embodiments, the one-way limiting structure is disposed at a preset position at the proximal end of the guide rod, the one-way limiting structure allows the connecting rope to move from the distal end to the proximal end along the guide rod, and the one-way limiting structure can abut against the connecting rope during the movement of the connecting rope from the proximal end to the distal end along the guide rod.

In some preferred embodiments, the guide rod comprises a first sub-guide rod and a second sub-guide rod, proximal ends of the first sub-guide rod and the second sub-guide rod are respectively connected to the positioning frame, and a guide space is formed between the first sub-guide rod and the second sub-guide rod; the one-way limiting structure comprises a limiting rod, the limiting rod is provided with a connecting end and a free end, the limiting rod is obliquely arranged in the guide space, the connecting end is connected with the first sub-guide rod, the free end is abutted against the second sub-guide rod, the connecting end is close to the far end, the free end is close to the near end, and the connecting rope is far away from one end of the valve support and is slidably sleeved on the second sub-guide rod.

In some preferred embodiments, the preset position of the second sub-guide rod has a blocking block, the blocking block is located on one side of the free end close to the proximal end, and during the process that the connecting rope slides from the proximal end of the second sub-guide rod to the distal end, the blocking block can block the gap between the free end and the second sub-guide rod, so as to prevent the end of the connecting rope from sliding out from the gap between the free end and the second sub-guide rod.

In some preferred embodiments, the valve stent has a fixing part at the proximal end, and the connecting rope is fixed at the fixing part at the end far away from the positioning frame.

In some preferred embodiments, the valve stent has threading holes at its proximal end, the threading holes forming the fixation portions.

In some preferred embodiments, the proximal end of the valve stent is provided with a first threading hole and a second threading hole which are adjacently arranged, the connecting rope passes through the second threading hole, and one end of the connecting rope, which is far away from the positioning frame, is fixed on the wall body of the first threading hole; the valve support in the location space by the transport state expand to the in-process of implantation state, first through wires hole with the distance between the second through wires hole increases, first through wires hole with between the second through wires hole connect the length of rope increase, the second through wires hole with between the locating rack connect the length of rope reduce.

In some preferred embodiments, the first link is a sliding block having a sliding hole, the sliding block is fixed to the proximal end of the valve holder, the guide rod is slidably mounted to the sliding hole, and the sliding hole forms the sliding channel.

In some preferred embodiments, the sliding block includes a base block and extension arms extending outwardly from the base block, the sliding holes are located on the extension arms, and the base block is fixedly attached to the valve holder.

In some preferred embodiments, a first limiting fixture block is arranged at a preset position of the distal end of the guide rod, and a proximal end of the first limiting fixture block is adapted to abut against the distal end of the sliding block so as to limit the sliding block.

In some preferred embodiments, the one-way limiting structure includes a second limiting clamping block disposed at a preset position of the proximal end of the guide rod, the proximal radial dimension of the second limiting clamping block is greater than the radial dimension of the sliding hole, the distal radial dimension of the second limiting clamping block is smaller than the radial dimension of the sliding hole, the distal end and the proximal end of the second limiting clamping block are connected through a guide inclined plane, and the proximal end of the second limiting clamping block has an abutting surface; the sliding block moves towards the near end along the guide inclined plane and passes through the second limiting clamping block, and the abutting surface can abut against the sliding block.

In some preferred embodiments, a proximal hollow hole extending in the length direction is formed at a position of the guide rod corresponding to the second limiting latch, and a distal hollow hole extending in the length direction is formed at a position of the distal end of the guide rod corresponding to the first limiting latch.

In some preferred embodiments, the distal end of the resilient arm has a barb extending proximally.

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

In some preferred embodiments, the valve stent comprises a stent body that is cylindrical in the implanted state, the stent body comprising a distal stent section and a proximal stent section, the distal stent section having a radial dimension that is greater than a radial dimension of the proximal stent section.

In some preferred embodiments, the stent body further comprises at least one intermediate stent segment located between the distal stent segment and the proximal stent segment, the intermediate stent segment having a radial dimension between the distal stent segment and the proximal stent segment.

In some preferred embodiments, the valve stent comprises a plurality of interconnected stent units surrounding the intercommunicating aperture, and a skirt rod within the intercommunicating aperture of the distal stent segment, the skirt rod having a predetermined position projecting radially outward.

In some preferred embodiments, the predetermined position of the skirt rod is inclined outwardly by an angle of 20 ° to 40 °.

In some preferred embodiments, the skirt rod is disposed along an axial direction of the communication hole.

In some preferred embodiments, the size of the communication holes at the distal end of the stent body is smaller than the size of the communication holes at the proximal end of the stent body.

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 mechanism comprising an elongate shaft for loading the positioning frame and the valve holder of the prosthetic valve, the delivery mechanism being configured to deliver and release the prosthetic valve to a preset position.

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 conveying system, the valve support and the positioning frame of the artificial valve are in sliding connection through the first connecting piece and the second connecting piece, and the valve support and the positioning frame can be effectively positioned in the implantation process;

2. according to the artificial valve and the transcatheter artificial valve conveying system provided by the invention, the near end of the guide rod is provided with the anti-drop groove or the limiting clamping block, and the anti-drop groove or the limiting clamping block can limit the first connecting piece and limit the first connecting piece to slide from the near end to the far end;

3. according to the artificial valve and the transcatheter artificial valve delivery system, the near end of the guide rod is provided with the near-end hollow hole, and the far end of the guide rod is provided with the far-end hollow hole, so that the rigidity of the guide rod can be reduced, and the guide rod can be conveniently bent;

4. according to the artificial valve and the transcatheter artificial valve delivery system, in the process that the valve stent is expanded from the delivery state to the implantation state, along with the reduction of the distance between the valve stent and the positioning frame, the length of the connecting rope between the valve stent and the positioning frame is correspondingly reduced, so that the relative position between the valve stent and the positioning frame can be better positioned;

5. the artificial valve comprises a valve support and a positioning frame matched with the valve support, wherein the positioning frame can be delivered to a heart valve of a patient in advance, so that the valve support can be effectively and accurately positioned;

6. in the delivery system, the valve stent and the positioning frame are placed in front and back and are not overlapped in radial direction, so that the diameter of the delivery catheter can be reduced, and the delivery catheter can conveniently enter a human body through a vascular path;

7. 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 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.

FIG. 1 is a schematic view of the overall structure of a prosthetic valve according to a first preferred embodiment of the present invention;

FIG. 2 is an enlarged view taken at a in FIG. 1;

FIG. 3 is an enlarged view at b in FIG. 1;

FIG. 4 is a schematic structural view of a modified embodiment of the prosthetic valve of the first preferred embodiment of the present invention;

fig. 5 is a schematic perspective view of a valve stent of a prosthetic valve according to a first preferred embodiment of the present invention in a positioning space of a positioning frame;

FIG. 6 is a front view of FIG. 5;

FIG. 7 is a top view of FIG. 5;

FIG. 8 is a perspective view of a positioning frame of a prosthetic valve according to a first preferred embodiment of the present invention;

FIG. 9 is a schematic structural view of a prosthetic valve according to a second preferred embodiment of the present invention;

FIG. 10 is a schematic structural view of a valve stent of a prosthetic valve according to a second preferred embodiment of the present invention positioned outside a stent in an implanted state;

FIG. 11 is an exploded view of a prosthetic valve according to a second preferred embodiment of the present invention;

FIG. 12 is an enlarged schematic view of FIG. 11 at c;

fig. 13 is an enlarged schematic view of d in fig. 11.

The reference numbers illustrate:

the valve stent 10, the fixing portion 11, the threading hole 110, the first threading hole 111, the second threading hole 112, the distal stent section 12, the proximal stent section 13, the middle stent section 14, the stent unit 15, the communication hole 150, the skirt rod 151, the positioning frame 20, the positioning space 21, the elastic arm 22, the delivery joint 23, the proximal bending section 221, the extension rod 222, the barb 223, the connecting assembly 30, the first connecting member 31, the sliding channel 310, the connecting rope 311, the sliding block 312, the sliding hole 3120, the base block 3121, the extension arm 3122, the second connecting member 32, the guide rod 321, the first sub-guide rod 3211, the second sub-guide rod 3212, the blocking block 32121, the limiting rod 3213, the connecting end 32131, the free end 32132, the guide space 3210, the proximal hollow hole 3214, the distal hollow hole 3125, the limiting block 322, the guide inclined surface 3221, and the abutting surface 3222.

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 the parts relevant to the invention are schematically shown in the drawings, and they do not represent the actual structure as a product. Moreover, in the interest of brevity and understanding, only one of the components having the same structure or function is illustrated schematically or designated in some of the drawings. In this document, "one" means not only "only one" 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, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

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.

In this application, "proximal" and "distal" are relative orientations, relative positions, directions of elements or actions with respect to each other from the perspective of a clinician using the medical device, although "proximal" and "distal" are not intended to be limiting, with "proximal" generally referring to the end of the medical device that is closer to the clinician during normal operation and "distal" generally referring to the end that is first introduced into a patient.

Referring to fig. 1 to 13, a prosthetic valve provided by a preferred embodiment of the present invention is illustrated, which includes a valve holder 10, a positioning frame 20, and a connecting assembly 30. The connecting assembly 30 comprises a first connecting member 31 and a second connecting member 32, the first connecting member 31 is connected to the valve holder 10, the second connecting member 32 is connected to the positioning frame 20, the first connecting member 31 is slidably connected to the second connecting member 32, and the connecting assembly 30 further comprises a one-way limiting structure arranged between the first connecting member 31 and the second connecting member 32.

The valve stent 10 and the positioning frame 20 both have a radially compressed delivery state and a radially expanded implantation state, the positioning frame 20 being capable of forming a positioning space 21 around native valve leaflets when in the implantation state;

at least one part of the valve stent 10 is adapted to enter the positioning space 21 when the positioning frame 20 is in the implantation state, and drives the first connecting piece 31 to slide relative to the second connecting piece 32, at least one part of the valve stent 10 can be unfolded in the positioning space 21 to the implantation state, the valve stent 10 and the positioning frame 20 can be positioned by virtue of the connecting assembly 30, and when the at least one part of the valve stent 10 moves in a direction away from the positioning space 21, the one-way limiting structure can limit the first connecting piece 31 and the second connecting piece 32 to slide relative to each other so as to limit the at least one part of the valve stent 10 to leave the positioning space 21.

Preferably, the valve stent 10 is loaded at the distal end of the delivery device relative to the positioning frame 20, and during the releasing process, the positioning frame 20 is delivered to a preset position and adjusted to the implantation state, then the valve stent 10 is pulled proximally into the positioning space 21, and then the valve stent 10 is adjusted to the implantation state. In some variations, the positioning frame 20 is loaded at the distal end of the delivery device relative to the valve stent 10, and during the releasing process, the positioning frame 20 is delivered to a preset position and adjusted to the implantation state, and then the valve stent 10 is pushed to the distal end into the positioning space 21, and then the valve stent 10 is adjusted to the implantation state.

During the process of implanting at least a part of the valve stent 10 into the positioning space 21 of the positioning frame 20, the first connecting piece 31 slides relative to the second connecting piece 32, and the connecting assembly 30 can position the valve stent 10 and the positioning frame 20 before or after the valve stent 10 enters the positioning space 21.

Referring to fig. 5, 6, 7, 8, 9 and 10, preferably, the second connecting member 32 is a guide rod 321, a proximal end of the guide rod 321 is connected to a proximal end of the positioning frame 20, a distal end of the guide rod 321 extends toward a distal end of the positioning frame 20, and the first connecting member 31 is slidably connected to the guide rod 321. In a variant embodiment, the first connector 31 is a guide rod 321, and the second connector 32 is slidably connected to the guide rod 321. In a variant embodiment, the first connector 31 and the second connector 32 are each a guide rod 321 and are able to be mutually sliding fitted.

Referring to fig. 3 and 4, the first connecting member 31 has a sliding channel 310, and the guide rod 321 is slidably mounted to the sliding channel 310. The guide rod 321 passes through the sliding channel 310 and can slide relative to the sliding channel 310, and the relative sliding between the first connector 31 and the second connector 32 is realized through the matching between the sliding channel 310 and the guide rod 321.

Referring to fig. 1, the first connecting member 31 is a connecting string 311, one end of the connecting string 311 is fixed to the proximal end of the valve holder 10, and one end of the connecting string 311 away from the valve holder 10 is knotted to form the sliding channel 310. Preferably, the connection string 311 is a flexible string.

During the process of placing the proximal end of the valve stent 10 into the positioning space 21 of the positioning frame 20, one end of the connecting rope 311, which is away from the valve stent 10, can slide along the length extension direction of the second connecting piece 32, and during the process of placing the proximal end of the valve stent 10 into the positioning space 21 of the positioning frame 20, the connecting rope 311 can position the relative position between the valve stent 10 and the positioning frame 20, so as to improve the stability of the relative positional relationship between the valve stent 10 and the positioning frame 20. The connecting rope 311 has a flexible structure, is easy to store, and does not interfere with the valve stent 10 and the positioning frame 20 during the implantation process.

The one-way limiting structure is arranged at a preset position of the near end of the guide rod 321, allows the connecting rope 311 to move from the far end to the near end along the guide rod 321, and can abut against the connecting rope 311 in the process that the connecting rope 311 moves from the near end to the far end along the guide rod 321.

Referring to fig. 2, the guide rod 321 includes a first sub-guide rod 3211 and a second sub-guide rod 3212, proximal ends of the first sub-guide rod 3211 and the second sub-guide rod 3212 are respectively connected to the positioning frame 20, and a guide space 3210 is formed between the first sub-guide rod 3211 and the second sub-guide rod 3212. The guide rod 321 further includes a limiting rod 3213, the limiting rod 3213 has a connecting end 32131 and a free end 32132, the limiting rod 3213 is obliquely disposed in the guide space 3210, the connecting end 32131 is connected to the first sub-guide rod 3211, the free end 32132 abuts against the second sub-guide rod 3212, the connecting end 32131 is close to the distal end, the free end 32132 is close to the proximal end, and one end of the connecting rope 311 away from the valve holder 10 is slidably sleeved on the second sub-guide rod 3212. The limiting rod 3213 forms the one-way limiting structure.

During the process that the end of the connecting rope 311 away from the valve stent 10 is moved proximally from the distal end of the second sub-guide rod 3212, the connecting rope 311 can push the free end 32132 to move away from the second sub-guide rod 3212, and pass through the gap between the free end 32132 and the second sub-guide rod 3212. In the process that one end of the connecting rope 311, which is far away from the valve stent 10, moves from the proximal end of the second sub-guide rod 3212 to the distal end, the limiting rod 3213 can limit the connecting rope 311, so as to prevent the connecting rope 311 from sliding from the proximal end of the second sub-guide rod 3212 to the distal end.

Further, the preset position of the second sub-guide rod 3212 has a blocking piece 32121, and the blocking piece 32121 is located on a proximal side of the free end 32132. In the process that the connection cord 311 slides from the proximal end to the distal end of the second sub-guide rod 3212, the blocking piece 32121 blocks a gap between the free end 32132 and the second sub-guide rod 3212, and prevents the end of the connection cord 311 from sliding out from the gap between the free end 32132 and the second sub-guide rod 3212.

In a modified embodiment, the proximal end of the guiding rod 321 is provided with a detachment prevention groove (not shown), the opening of the detachment prevention groove is close to the proximal end, the groove bottom is close to the distal end, and the detachment prevention groove forms the one-way limiting structure. When the end of the connecting rope 311 far away from the valve stent 10 moves from the distal end to the proximal end along the second connecting piece 32, the end of the connecting rope 311 far away from the valve stent 10 enters the anti-release groove, and when the valve stent 10 moves distally relative to the positioning frame 20, the end of the connecting rope 311 far away from the valve stent 10 abuts against the groove bottom of the anti-release groove, so that the end of the connecting rope 311 far away from the valve stent 10 is limited, and the valve stent 1 is prevented from moving distally relative to the positioning frame 20.

Referring to fig. 3 and 4, the fixing part 11 is provided at the proximal end of the valve stent 10, and one end of the connecting rope 311 away from the positioning frame 20 is fixed to the fixing part 11. Preferably, the valve stent 10 has a threading hole 110 at a proximal end thereof, the threading hole 110 forms the fixing portion 11, and one end of the connecting string 311, which is away from the positioning frame 20, passes through the threading hole 110 and is fixed to a side wall of the threading hole 110. In some variant embodiments, the protrusion or the groove of the proximal end of the valve stent 10 forms the fixing part 11, and the specific form of the fixing part 11 should not be limited as long as the purpose of fixing the connecting string 311 can be achieved.

The valve stent 10 has a first threading hole 111 and a second threading hole 112 arranged adjacently at the proximal end. The connecting string 311 passes through the second string hole 112, and one end of the connecting string 311 away from the positioning frame 20 is fixed to the first string hole 111. In the process that the valve stent 10 is expanded from the delivery state to the implantation state in the positioning space 21, the distance between the first threading hole 111 and the second threading hole 112 is increased, the length of the connecting rope 311 between the first threading hole 111 and the second threading hole 112 is increased, and the length of the connecting rope 311 between the second threading hole 112 and the positioning frame 20 is decreased.

During the expansion of the valve stent 10 from the delivery state to the implantation state, as the distance between the valve stent 10 and the positioning frame 20 decreases, the length of the connecting strings 311 between the valve stent 10 and the positioning frame 20 decreases accordingly, so that the relative position between the valve stent 10 and the positioning frame 20 can be better positioned.

Preferably, the number of the second connecting members 32 implemented as the guide bars 321 and the first connecting members 31 implemented as the connecting ropes 31 is three, respectively, and are uniformly distributed. It is understood that in some variant embodiments, the number of connecting assemblies 30 can also be one, two, four or more, and the number of connecting assemblies 30 should not constitute a limitation of the present application.

Referring to fig. 9, 10, 11 and 13, in another preferred embodiment, the first link 31 is a sliding block 312, the sliding block 312 has a sliding hole 3120, the sliding block 312 is fixed to the proximal end of the valve holder 10, the guide rod 321 is slidably mounted to the sliding hole 3120, and the sliding hole 3120 forms the sliding channel 310. In a variant embodiment, the sliding channels 310 are formed by lateral sliding grooves of the sliding block 312.

Further, the sliding block 312 includes a base block 3121 and an extension arm 3122 extending outward from the base block 3121, the sliding hole 3120 is located in the extension arm 3122, and the base block 3121 is fixedly connected to the valve holder 10.

The far end and the near end of the guide rod 321 are respectively provided with a limiting fixture block 322, the far end is provided with a first limiting fixture block, the near end is provided with a second limiting fixture block, and the second limiting fixture block forms the one-way limiting structure. The radial size of the proximal end of the limiting fixture block 322 is greater than the radial size of the sliding hole 3120, the radial size of the distal end of the limiting fixture block 322 is less than the radial size of the sliding hole 3120, the distal end and the proximal end of the limiting fixture block 322 are connected by a guiding inclined plane 3221, and the proximal end of the limiting fixture block 322 is provided with an abutting surface 3222; after the sliding block 312 moves proximally along the guiding inclined plane 3221 and passes over the position-limiting latch 322, the abutting surface 3222 can abut against the sliding block 312 to limit the sliding of the sliding block 312 from the proximal end to the distal end.

Referring to fig. 11, a proximal end of the guide rod 321 corresponding to the second stopper has a proximal hollow hole 3214 extending in a length direction, and a distal end of the guide rod 321 corresponding to the first stopper has a distal hollow hole 3125 extending in the length direction. The proximal hollow hole 3214 and the distal hollow hole 3125 may reduce rigidity of the guide rod 321, allowing the guide rod to radially contract through the sliding hole 3120 when the sliding block 312 passes over the first limit latch and the second limit latch. The guide rods 321 are convenient to bend when the valve stent 10 is implanted into the positioning space 21 of the positioning frame 20, and the guide rods 21 are prevented from being broken. In some variations, the proximal hollow bore 3214 and the distal hollow bore 3125 communicate.

Referring to fig. 8, specifically, the positioning frame 20 includes at least three elastic arms 22, each elastic arm 22 includes a proximal bending section 221 and an extending rod 222 extending from two ends of the proximal bending section 221 to a distal end, proximal ends of the extending rods 222 adjacent to the elastic arms 22 are integrally connected, and the second connecting member 32 is connected to the proximal bending section 221 of the elastic arm 22. In some variant embodiments, the second connecting member 32 can also be connected to the extension rod 222 of the positioning frame 20, and the specific position of the second connecting member 32 connected to the positioning frame 20 should not be construed as limiting the application.

Further, the distal end of the resilient arm 22 has a proximally extending barb 223. When the locating rack 20 expands to the implantation state, the barb 223 can contact with human tissue, so that the implantation stability of the locating rack 20 is improved.

Referring to fig. 11, the valve stent 10 is cylindrical in the implanted state, and the valve stent 10 includes a stent body having a distal stent section 12 and a proximal stent section 13, the distal stent section 12 having a radial dimension greater than the radial dimension of the proximal stent section 13. In use, the distal stent section 12 with the larger radial dimension can contact with the heart tissue of the human body more sufficiently, effectively reducing the risk of paravalvular leakage.

The stent body also has at least one intermediate stent section 14 located between the distal stent section 12 and the proximal stent section 13, the intermediate stent section 14 having a radial dimension between the distal stent section 12 and the proximal stent section 13. In some variations, the intermediate frame section 14 is outwardly convex.

The valve stent 10 further includes a sealing membrane sutured to the stent body and bovine pericardial leaflets provided in the interior space of the stent body.

Compared with the proximal stent section 13, the middle stent section 14 has a larger radial size, and the inner surface area of the middle stent section 14 can be increased, so that the installation area of the bovine pericardial valve leaflet can be increased, and the technical effect of reducing the edge beating of the valve leaflet can be achieved. The valve support 10 adopts a multi-section structural design, so that the friction force between the valve support 10 and human tissues can be improved, and the implantation stability is improved.

The stent main body includes a plurality of stent units 15 connected to each other, the stent units 15 surround to form a communication hole 150, and the communication hole 150 communicates an inner space and an outer space of the stent main body. In other words, the stent body of the valve stent 10 is a lattice-like structure.

Referring to fig. 11, in a variant embodiment, the stent body further comprises a skirt rod 151 located within the communication hole 150 of the distal stent segment 12, a predetermined position of the skirt rod 151 being disposed to protrude radially outward. In the use, the skirt rod 151 radially outwards protrudes and is capable of fully contacting with the heart tissue of a human body, and the risk of perivalvular leakage is effectively reduced. Preferably, the predetermined position of the skirt rod 151 is inclined outwardly at an angle of 20 to 40 degrees.

Preferably, the skirt rod 151 is disposed along an axial direction of the communication hole 150, both ends of the skirt rod 151 are fixed to a wall of the communication hole 150, and a middle of the skirt rod 151 is protruded radially outward.

Further, the size of the communication hole 150 at the distal end of the stent main body is smaller than the size of the communication hole 150 at the proximal end of the stent main body, so that the plugging effect of the distal end of the stent main body can be increased, and the risk of paravalvular leakage can be further reduced.

Referring to fig. 1, the positioning frame 20 and the valve stent 10 are each provided with a delivery joint 23 for connecting a delivery mechanism, and an operator can operate the delivery mechanism to transport the positioning frame 20 and the valve stent 10 to a preset position and release the delivery joint.

Preferably, the positioning frame 20 and the delivery connector 23 of the valve stent 10 are both provided at the proximal end. In some variant embodiments, the positioning frame 20 and the delivery joint 23 of the valve stent 10 can also be disposed at a distal or intermediate position, and the position of the delivery joint 23 should not constitute a limitation to the present application as long as the delivery needs can be accomplished.

According to another aspect of the invention, the invention further provides a transcatheter prosthetic valve replacement system comprising the prosthetic valve of the above-described embodiment and a delivery mechanism. The delivery mechanism comprises an elongate shaft for loading the positioning frame 20 and the valve holder 10 of the prosthetic valve, and is capable of delivering the prosthetic valve to a preset position and releasing. The elongated shaft of the delivery mechanism is provided with clamping jaws which are matched with the delivery joint 23 and can clamp the delivery joint 23, and after the positioning frame 20 and the valve stent 10 of the artificial valve are delivered to a preset position, the clamping jaws can release the delivery joint 23 to release the artificial valve.

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 those skilled in the art can make various improvements and modifications without departing from the principle of the present invention, and these improvements and modifications should also be construed as the protection scope of the present invention.

Claims (24)

1. A prosthetic valve, comprising:

a valve stent;

a positioning frame;

the connecting assembly comprises a first connecting piece and a second connecting piece, the first connecting piece is connected to the valve support, the second connecting piece is connected to the positioning frame, the first connecting piece is connected to the second connecting piece in a sliding mode, and the connecting assembly further comprises a one-way limiting structure arranged between the first connecting piece and the second connecting piece;

the valve stent and the positioning frame are both provided with a radial compressed delivery state and a radial expanded implantation state, and the positioning frame can form a positioning space around native valve leaflets when in the implantation state;

at least one part of the valve support is suitable for entering the positioning space when the positioning frame is in the implantation state and driving the first connecting piece to slide relative to the second connecting piece, at least one part of the valve support can be unfolded in the positioning space to be in the implantation state, the valve support and the positioning frame can be positioned by virtue of the connecting assembly, and when the at least one part of the valve support moves in the direction leaving the positioning space, the one-way limiting structure can limit the first connecting piece and the second connecting piece to slide relatively so as to limit the at least one part of the valve support to leave the positioning space.

2. The prosthetic valve of claim 1, wherein the second connector is a guide rod, a proximal end of the guide rod being coupled to a proximal end of the positioning frame, a distal end of the guide rod extending toward a distal end of the positioning frame, the first connector being slidably coupled to the guide rod.

3. The prosthetic valve of claim 2, wherein the first connector has a slide channel, the guide rod being slidably mounted to the slide channel.

4. The prosthetic valve of claim 3, wherein the first connector is a connecting string having one end secured to the proximal end of the valve holder, the end of the connecting string distal from the valve holder being knotted to form the sliding channel.

5. The prosthetic valve of claim 4, wherein the one-way stop is disposed at a predetermined proximal position on the guide rod, the one-way stop allowing the connecting cord to move distally to proximally along the guide rod, the one-way stop being configured to abut against the connecting cord during proximal to distal movement of the connecting cord along the guide rod.

6. The prosthetic valve of claim 5, wherein the guide rod comprises a first sub-guide rod and a second sub-guide rod, the proximal ends of the first sub-guide rod and the second sub-guide rod are respectively connected to the positioning frame, and a guide space is formed between the first sub-guide rod and the second sub-guide rod; the one-way limiting structure comprises a limiting rod, the limiting rod is provided with a connecting end and a free end, the limiting rod is obliquely arranged in the guide space, the connecting end is connected with the first sub-guide rod, the free end abuts against the second sub-guide rod, the connecting end is close to the far end, the free end is close to the near end, and the connecting rope is far away from one end of the valve support and can be slidably sleeved on the second sub-guide rod.

7. The prosthetic valve of claim 6, wherein the second sub-guide rod has a blocking block at a predetermined position, the blocking block is located at a side of the free end near the proximal end, and the blocking block can block a gap between the free end and the second sub-guide rod during the sliding of the connecting string from the proximal end to the distal end of the second sub-guide rod, so as to prevent the end of the connecting string from sliding out of the gap between the free end and the second sub-guide rod.

8. The prosthetic valve of claim 4, wherein the proximal end of the valve stent has a fixation portion to which an end of the connecting string distal to the spacer is secured.

9. The prosthetic valve of claim 8, wherein the proximal end of the valve stent has threading holes that form the fixation portions.

10. The prosthetic valve of claim 9, wherein the proximal end of the valve support has a first threading hole and a second threading hole which are adjacently disposed, the connecting rope passes through the second threading hole, and one end of the connecting rope, which is far away from the positioning frame, is fixed on the wall body of the first threading hole; the valve support in the location space by the transport state expand to the in-process of implantation state, first through wires hole with the distance between the second through wires hole increases, first through wires hole with between the second through wires hole connect the length of rope increase, the second through wires hole with between the locating rack connect the length of rope reduce.

11. The prosthetic valve of claim 3, wherein the first connector is a sliding block having a sliding aperture, the sliding block being secured to the proximal end of the valve holder, the guide rod being slidably mounted in the sliding aperture, the sliding aperture forming the sliding channel.

12. The prosthetic valve of claim 11, wherein the sliding block includes a base block and extension arms extending outwardly from the base block, the sliding holes being located in the extension arms, the base block being fixedly attached to the valve holder.

13. The prosthetic valve of claim 11, wherein a first limiting block is disposed at a predetermined position of the distal end of the guide rod, and a proximal end of the first limiting block is adapted to abut against the distal end of the sliding block to limit the sliding block.

14. The prosthetic valve according to claim 13, wherein the one-way retention structure comprises a second retention clip disposed at a predetermined position of the proximal end of the guide rod, a proximal radial dimension of the second retention clip is larger than a radial dimension of the sliding hole, a distal radial dimension of the second retention clip is smaller than the radial dimension of the sliding hole, the distal end and the proximal end of the second retention clip are connected by a guide inclined surface, and the proximal end of the second retention clip has an abutment surface; and after the sliding block moves towards the near end along the guide inclined plane and passes through the second limiting clamping block, the abutting surface can abut against the sliding block.

15. The prosthetic valve of claim 14, wherein the guide rod is provided with a proximal hollow hole extending in the length direction at a position corresponding to the second limiting block, and the distal end of the guide rod is provided with a distal hollow hole extending in the length direction at a position corresponding to the first limiting block.

16. The prosthetic valve of claim 1, wherein the distal end of the resilient arm has a barb extending proximally.

17. The prosthetic valve of claim 1, wherein the positioning frame comprises at least three elastic arms, each elastic arm comprises a proximal bending section and an extension rod extending from two ends of the proximal bending section to a distal end, and proximal ends of the extension rods adjacent to the elastic arms are integrally connected.

18. The prosthetic valve of claim 1, wherein the valve holder comprises a holder body that is cylindrical in the implanted state, the holder body comprising a distal holder segment and a proximal holder segment, the distal holder segment having a radial dimension that is greater than a radial dimension of the proximal holder segment.

19. The prosthetic valve of claim 18, wherein the stent body further comprises at least one intermediate stent segment positioned between the distal stent segment and the proximal stent segment, the intermediate stent segment having a radial dimension between the distal stent segment and the proximal stent segment.

20. The prosthetic valve of claim 18, wherein the valve stent comprises a plurality of interconnected stent units surrounding a communicating aperture, the valve stent further comprising a skirt rod within the communicating aperture of the distal stent segment, a predetermined position of the skirt rod being disposed to project radially outward.

21. The prosthetic valve of claim 20, wherein the preset position of the skirt stem is outwardly inclined at an angle of 20 ° to 40 °.

22. The prosthetic valve stent of claim 20, wherein the skirt rod is disposed along an axial direction of the communication hole.

23. The prosthetic valve of claim 20, wherein the communication holes at the distal end of the stent body are smaller in size than the communication holes at the proximal end of the stent body.

24. A transcatheter prosthetic valve delivery system, comprising:

the prosthetic valve of any one of claims 1-23;

a delivery mechanism comprising an elongate shaft for loading the positioning frame and the valve holder of the prosthetic valve, the delivery mechanism being configured to deliver and release the prosthetic valve to a preset position.

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