Patent Description:
At present, transcatheter mitral valve replacement (tmvr) has become a research hotspot at home and abroad, but there are some core problems, such as large stent size, left ventricular outflow tract interference, and anchorage difficulties. In order to solve the problem of valve anchoring of large-scale mitral valve stent, some foreign companies have taken different attempts, such as the intrepid mitral valve of Medtronic company, which uses the anchoring thorns on the stent to fix the valve; for example, the CardiAQe mitral valve of Edward company, which uses the way of hooking the original mitral valve leaf to anchor the prosthesis; such as Highlife company's interventional valve uses an additional anchor ring to bind the prosthesis to the primary leaflet. Generally speaking, the way of using the prick anchorage is simple to operate and little affected by the difference of anatomy. However, there are still following problems: the valve stent and the prick structure are made in one, which makes the crooked and protruding prick structure not only limit the size of the delivery catheter and the length of the valve stent, but also easily lead to the failure of the anchorage caused by the fracture of the prick anchorage, and hinder the recovery of the valve when the release is not in place. <CIT> discloses a heart valve annulus repair device having a tissue engaging member and a plurality of anchors. <CIT> discloses an anchoring device for use within a vascular structure including a head having a first surface and a second surface meeting at a common plane, and an anchor including a shaft having a longitudinal axis, a first end connected at a junction to the first surface of the head, and a free end.

Based on this, it is necessary to provide a cardiac valve prosthesis, a delivery device and a method for loading and releasing the cardiac valve prosthesis, by setting the valve stent and the thorn structure independently, the size of the delivery device and the length of the valve stent can be reduced, so that the risk of fracture can be reduced, and the valve can be recovered when the release is not in place.

There is provided a cardiac valve prosthesis as claimed in claim <NUM>.

The above mentioned cardiac valve prosthesis, by setting the valve stent and the thorn structure independently, can be manufactured and processed separately, and can cooperate with each other by no connecting way, so as to facilitate the loading and release step by step, further the size of the delivery device and the length of the valve stent can be reduced, the risk of fracture can be reduced, and the cardiac valve prosthesis can be recovered when the release is not in place.

In an alternative embodiment, the thorn structure further comprising:.

In an alternative embodiment, the tips of the multiple thorns are conical tips, pyramid tips or prismatic tips.

In an alternative embodiment, wherein the tips of the multiple thorns provided with multiple barb structures.

In an alternative embodiment, the material of the multiple thorns is medical biodegradable material.

In an alternative embodiment, the medical biodegradable material comprising at least one of polycaprolactone, polylactic acid and polyglycolic acid copolymer.

In an alternative embodiment, the multiple thorns and the thorn lug are respectively provided at the connection between any two of the multiple connecting rods.

In an alternative embodiment, the multiple fixing holes comprising dense grids arranged along the circumferential direction of the valve stent, and the size of the dense grids is smaller than that of other grids on the valve stent.

In an alternative embodiment, the size of the dense grids is <NUM>/<NUM> to <NUM>/<NUM> of that of other grids on the valve stent.

In an alternative embodiment, the valve stent comprising an inflow channel part for blood inflow and an outflow channel part for blood outflow; and.

A delivery device according to claim <NUM> for loading the cardiac valve prosthesis of any of the above items,
wherein the delivery device comprising:.

The above mentioned delivery device, can realize the loading and releasing operation of the thorn structure and the valve stent step by step using the delivery catheter formed by the first catheter assembly and the second catheter assembly, further can improve the fixation strength and accuracy of the cardiac valve prosthesis, at the same time, it is convenient for the operator to operate, and it is also convenient for recovery when the release of the cardiac valve prosthesis is not in place.

In an alternative embodiment, the control handle comprising a first control part and a second control part, the first control part is connected with the first catheter assembly for controlling the first catheter assembly, the second control part is connected with the second catheter assembly for controlling the second catheter assembly.

In an alternative embodiment, the first catheter assembly comprising:.

In an alternative embodiment, the first control part comprising:
a first control structure connected with the thorn external catheter for controlling the movement of the thorn external catheter relative to the thorn inner catheter.

In an alternative embodiment, the second catheter assembly comprising:.

In an alternative embodiment, the second control part comprising:
a second control structure connected with the valve stent external catheter for controlling the movement of the valve stent external catheter relative to the valve stent inner catheter.

In order to make the purpose, technical scheme and advantages of the present invention clearer, the present invention will be further described in detail below in combination with the drawings and embodiments. It should be understood that the specific embodiments described herein are only used to interpret the present invention and are not used to define the present invention.

The present invention uses schematic diagrams for detailed description, but these schematic diagrams are only for the convenience of detailing examples of the present invention, and should not be regarded as the limitation of the present invention. As used in the specification and the appended claims, the singular forms "a", "one" and "the" include plural objects, unless the content otherwise expressly indicates. As used in this specification and the appended claims, the term "or" is generally used to include the meaning of "and/or", unless the content otherwise expressly indicates. The term "proximal end" usually refers to the end close to the operator, "distal end" refers to the end far away from the operator.

<FIG> is a schematic view illustrating the structure of the cardiac valve prosthesis according to one embodiment of this invention. As shown in <FIG>, an expandable valve stent comprising an expandable artificial valve (i.e. valve leaf) <NUM>, an expandable valve stent <NUM> and a thorn structure <NUM>, the artificial valve is provided on the valve stent <NUM>. Multiple fixing holes <NUM> are provided on the valve stent <NUM>, wherein the thorn structure <NUM> can pass through the multiple fixing holes <NUM> and penetrate tissue in the cardiac chamber so as to fix the valve stent <NUM> at a preset position when the cardiac valve prosthesis is implanted into a cardiac chamber, so that the artificial valve <NUM> can replace human tissues such as mitral valve to work, so as to achieve the purpose of treating mitral valve disease.

Specifically, as shown in <FIG>, the valve stent <NUM> is a tubular expandable structure, which is easy to be loaded into the delivery device during compression. When the valve stent <NUM> is implanted into the human body through the delivery device and released, the valve stent <NUM> can be expanded to a preset size to play a supporting role. The valve stent <NUM> comprising an inflow channel part <NUM> and an outflow channel part <NUM>, the inflow channel part <NUM> can be used as a channel for blood to flow into the cardiac valve prosthesis, and the outflow channel part <NUM> can be used as a channel for blood to flow out of the cardiac valve prosthesis. After the cardiac valve prosthesis is implanted, the inflow channel part <NUM> is located at the left atrial end, the outflow part <NUM> is located at the left ventricular end, and the thorn structure <NUM> can be inserted into the mitral valve ring to fix the valve stent <NUM>.

The artificial valve <NUM> can be made of biological materials such as bovine pericardium, horse pericardium or pig pericardium, and the artificial valve <NUM> can be sutured (such as three valve leaf suture) and fixed on the valve stent <NUM> by the suturing process, that is to say, in normal operation, the blood flows from the left atrium through the inflow channel part <NUM> by the artificial valve <NUM>, and through the outflow channel part <NUM> into the left ventricle.

Further, as shown in <FIG>, in order to make the thorn structure <NUM> more stable for fixing the valve stent <NUM>, the multiple fixing holes <NUM> can be provided in the inflow channel part <NUM> or the junction of the inflow channel part <NUM> and the outflow channel part <NUM>. At the same time, in order to further improve the stability and operation convenience, the multiple fixing holes <NUM> can be evenly distributed along the circumference. The valve stent <NUM> can further be a dumbbell structure, that is, the opening at both ends is large and the middle part is small, and the diameter at the junction of the inflow channel part <NUM> and the outflow channel part <NUM> is smaller than the port diameter of the outflow channel part <NUM> and the inflow channel part <NUM>. Further, the port diameter of the inflow channel part <NUM> is bigger than the port diameter of the outflow channel part <NUM>. The port diameter <NUM> of the inflow channel part <NUM> can be <NUM>~<NUM> (such as <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or <NUM>, etc.), the port diameter of the outflow channel part <NUM> can be <NUM>~<NUM> (such as <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or <NUM>, etc.), the diameter at the junction of the inflow channel part <NUM> and the outflow channel part <NUM> can be <NUM>~<NUM> (such as <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or <NUM> etc.).

Further, as shown in <FIG>, the valve stent <NUM> can be a tubular diamond-shaped grids structure prepared by weaving or cutting with shape memory alloy such as nickel titanium alloy, so as to facilitate compression into a smaller diameter delivery catheter during implantation. For example, <NUM>~<NUM> grids (such as <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or <NUM> grids) are provided along the circumferential direction of the valve stent <NUM>, <NUM>~<NUM> rows of grids are provided along the axial direction. In order to make the valve stent <NUM> more stable, the size and shape of each grid in the same circumferential direction can be set to be the same, so that the expanded valve stent <NUM> has a circular grid evenly distributed in the circumferential direction, further improving the radial support force of the valve stent <NUM>, that is to say, when the valve stent <NUM> is expanded, the primary valve leaf can be opened, and the artificial valve <NUM> can be fixed at the preset position by the thorn structure <NUM> to fix the expanded valve stent <NUM>. Wherein, the multiple fixing holes <NUM> can be dense grids arranged along the circumferential direction of the valve stent <NUM>, and the size of the each dense grid is smaller than that of other grids on the valve stent <NUM>. In order to ensure that the thorn structure <NUM> has a better fixing effect, the size of the dense grids can be <NUM>/<NUM> to <NUM>/<NUM> of that of other grids on the valve stent <NUM>.

Multiple thorn lugs <NUM> of valve stent for loading are provided at the opening end of the inflow channel part <NUM>, and fillet can be used for smooth transition between different grids (such as grids of the valve stent <NUM>, dense grids, grids of the valve stent <NUM> and dense grids) of the valve stent <NUM>, and the radius of fillet can be <NUM> ~ <NUM> (such as <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or <NUM> etc.).

<FIG> is a schematic view illustrating the thorn structure in <FIG>. As shown in <FIG> and <FIG>, based on the above mentioned embodiment, the thorn structure <NUM> comprising a thorn stent <NUM> and multiple thorns <NUM>, and the multiple thorns <NUM> are fixedly provided on the thorn stent <NUM>, so that when the cardiac valve prosthesis is implanted, the multiple thorns <NUM> penetrates the multiple fixing holes <NUM> one by one correspondingly into the human tissue, and the valve stent <NUM> is fixed with the thorn stent <NUM>. Wherein, the thorn stent <NUM> comprising multiple connecting rods <NUM>, the multiple connecting rods <NUM> connected end to end to form a closed chain structure as shown in <FIG>, wherein, any two adjacent connecting rods form a V-shaped structure. Of course, in other embodiments, the thorn stent <NUM> may also be a mesh structure composed of multiple diamond-shaped grids, which is not limited by the present invention.

The thorn stent <NUM> can also be expandable structure, preferably made of shape memory alloy material, such as nickel titanium alloy, to facilitate compression and loading into the delivery device, and release when the cardiac valve prosthesis is implanted. The thorns <NUM> provided on the thorn stent <NUM> is pierced into the cardiac cavity tissue through the above-mentioned fixing holes from the inside of the expanded valve stent <NUM>, and then the valve stent <NUM> is fixed.

Specifically, as shown in <FIG>, in the above-mentioned thorn structure <NUM>, a thorn <NUM> can be provided at the end connection of two adjacent connecting rods <NUM>, and the tip of the thorn <NUM> may protrude out of the thorn stent <NUM>, toward the external area of the thorn stent <NUM>, so as to be inserted and fixed in the cardiac cavity tissue through the fixing hole <NUM>. Wherein, the size of the thorn stent <NUM> in the fully expanded state is greater than or equal to the size of the valve stent <NUM> in the fully expanded state. The position of the thorn <NUM> on the thorn stent <NUM> matches the position of the fixing hole <NUM> on the valve stent <NUM>, and the size of the thorn <NUM> on the thorn stent <NUM> is smaller than the size of the fixing hole <NUM> on the valve stent <NUM>, so that the thorn <NUM> can smoothly pass through the fixing hole <NUM> on the valve stent <NUM>, inserted into human cardiac cavity tissue for internal fixation.

<FIG> is a partial enlarged schematic view illustrating the thorn structure in <FIG>. As shown in <FIG>, in an alternative embodiment, the connecting node of the connecting rod <NUM> can be provided with a thorn <NUM> and a thorn lug <NUM>, the thorn <NUM> is provided at the distal end of the thorn stent <NUM>, and the thorn lug <NUM> is provided at the proximal end of the thorn stent <NUM>. Further, the thorn lug <NUM> and the thorn <NUM> can be provided in intervals at different connecting nodes of the thorn stent <NUM>, and the thorn <NUM> extends in the direction away from the central axis of the thorn stent <NUM>, while the thorn lug <NUM> extends in the direction close to the central axis of the thorn stent <NUM>, so as to facilitate the loading and release of the thorn structure <NUM>. For example, as shown in <FIG>, multiple fixing holes <NUM> are uniformly distributed in the circumferential direction of the expanded valve stent <NUM>, while multiple thorns <NUM> are provided in the position of the fixing holes <NUM> corresponding to the expanded thorn stent <NUM>, and <NUM>-<NUM> thorn lugs <NUM> are evenly provided in the expanded thorn stent <NUM>.

Further, <FIG> are schematic views illustrating different shapes of thorn tips passing through fixing holes. <FIG> is a schematic view illustrating a thorn tip with a barb structure passing through a fixing hole. As shown in <FIG>, one end of the thorn <NUM> is a free end, the other end of the thorn <NUM> is a non-free end, and the free end of the thorn <NUM> is a tip. For example, the tip of the thorn <NUM> can be a conical tip 301a shown in <FIG>, a pyramidal tip 301b shown in <FIG> and/or a prismatic tip 301c shown in <FIG>, etc., and in order to further improve the fixation performance of the thorn <NUM>, barb structures <NUM> shown in <FIG> can also be provided at the tip of the thorn <NUM>.

As shown in <FIG>, the thorn <NUM> and the connecting rod <NUM> can be manufactured integrally to reduce the manufacturing cost and the process difficulty. For example, shape memory metals such as nickel titanium alloy can be used to manufacture the thorn structure <NUM> by cutting and other processes, or traditional metal materials such as stainless steel, polymer materials, degradable materials can be used to manufacture the thorn structure <NUM>. Preferably, because the thorn structure <NUM> is mainly fixed in the early stage of prosthesis implantation, when the valve stent <NUM> is wrapped by endothelium in the later stage, the thorn <NUM> will lose its original localization function, and the remaining thorn structure <NUM> will cause permanent trauma to the valve ring tissue. In order to reduce the many complications caused by the residual thorn <NUM>, the thorn <NUM> and the connecting rod <NUM> can be manufactured separately, and the thorn structure <NUM> can be formed through such welding or mechanical cooperation connection, so as to facilitate the removal of the thorn <NUM> at the later stage of prosthesis implantation. For example, at least one or more degradable medical biomaterials, such as polycaprolactone, polylactic acid or polyacetic glycolic acid copolymer, can be used to prepare the thorn <NUM>, while metal or polymer materials, such as nickel titanium alloy and stainless steel, can be used to manufacture the connecting rod <NUM>, so that the connecting rod <NUM> can maintain the existing supporting role, while the thorn <NUM> is used for fixation in the early stage of prosthesis implantation In the later stage, it will degrade automatically to avoid the complications caused by the residual thorn <NUM>.

In practical application, when the valve prosthesis is implanted into the human body, the valve stent <NUM> can be released and implanted first, and then the thorn structure <NUM> can be released inside the expanded valve stent <NUM>, so that the thorn <NUM> can penetrate the fixing hole <NUM> on the valve stent <NUM> and penetrate into the primary valve ring and/or valve leaf of the patient, so that the valve stent <NUM> can be fixed at the preset position without loosening. Wherein, when the valve stent <NUM> is fixed at a preset position, the artificial valve leaf may be located below the thorn <NUM>. For example, the axial distance between the highest point of the valve leaf and the thorn <NUM> is <NUM>-<NUM>, preferably <NUM>-<NUM>.

The valve prosthesis in the above-mentioned embodiment, because the thorn structure <NUM> and the valve stent <NUM> are manufactured separately, and the valve prosthesis is fixed based on the step by step loading and release and mechanical cooperation, so as to avoid the fracture and fall off of the thorn structure made in one body, and cause complications such as thrombus, stem plug, etc. At the same time, the separately manufactured thorn structure and valve stent can also freely choose the direction of the turning of the thorn <NUM> according to the actual situation, which is conducive to the recovery of the valve, and the degradable material of the thorn can effectively avoid the permanent damage to the tissue, and facilitate the re-implantation of the same type of valve prosthesis.

<FIG> is a schematic view illustrating the structure of the front end part after the thorn structure is loaded in the delivery device according to one embodiment of this invention. <FIG> is a schematic view illustrating the overall structure after the thorn structure and the valve stent are loaded in the delivery device in <FIG>. As shown in <FIG> and <FIG>, the delivery device in the embodiment can be used to load any valve prosthesis in the above-mentioned embodiment. The delivery device can be composed of multiple nested delivery catheters, specifically comprising a conical head <NUM>, a control handle <NUM> and a delivery catheter <NUM>. The proximal end of the delivery catheter <NUM> is connected with the control handle <NUM>, and the distal end of the delivery catheter <NUM> is connected with the conical head <NUM>.

Specifically, as shown in <FIG>, the delivery catheter <NUM> comprising a first catheter assembly <NUM> and a second catheter assembly <NUM> sleeved outside the first catheter assembly <NUM>, the first catheter assembly <NUM> can be used to load and deliver the thorn structure <NUM>, the second catheter assembly <NUM> can be used to load and deliver valve stent <NUM>. The control handle <NUM> is used to control the second catheter assembly 42to release the valve stent <NUM> and control the first catheter assembly <NUM> to release the thorn structure <NUM> after the valve stent <NUM> is expanded, So that the thorn <NUM> in the thorn structure <NUM> is pierced into the human tissue through the fixing hole <NUM> on the valve stent <NUM>, so as to fix the valve stent <NUM> at a preset position, so that the artificial valve <NUM> can work instead of the original valve leaf.

The first catheter assembly <NUM> is provided inside the second catheter assembly <NUM>. Correspondingly, the control handle <NUM> comprising a first control part <NUM> and a second control part <NUM>, the first control part <NUM> is connected with the first catheter assembly <NUM> for controlling the first catheter assembly <NUM>, the second control part <NUM> is connected with the second catheter assembly <NUM> for controlling the second catheter assembly <NUM>.

In the above-mentioned embodiment, because the thorn structure <NUM> and the valve stent <NUM> are manufactured and loaded respectively, the diameter of the delivery catheter <NUM> and the height of the valve stent <NUM> can be reduced, so as to facilitate the atrial septal approach. It is convenient for catheters to be implanted into human body through femoral vein, right atrium through vein, and left atrium through ovum puncture, so as to reduce the trauma to human tissue.

As shown in <FIG>, in an alternative embodiment, the first catheter assembly <NUM> comprising a soft catheter <NUM>, a first fixing head, a thorn external catheter <NUM>, a thorn inner catheter <NUM> and an inner core catheter <NUM>. Wherein one end of the first fixing head <NUM> is respectively connected with the thorn inner catheter <NUM> and the inner core catheter <NUM>, the inner core catheter <NUM> is provided in the thorn inner catheter <NUM>, and the other end of the inner core catheter <NUM> can be connected to the first control part <NUM>. Another end of the fixing head <NUM> is connected to the conical head <NUM>, the thorn inner catheter <NUM> is provided inside the thorn external catheter <NUM>, so that the thorn external catheter <NUM> is sleeved on the thorn inner catheter <NUM>, and the proximal ends of the thorn external catheter <NUM> and the thorn inner catheter <NUM> are respectively connected with the first control part <NUM>. When the first control part <NUM> moves, the thorn external catheter <NUM> and the thorn inner catheter <NUM> can be driven to move synchronously. Specifically, the first control unit <NUM> also has a first control structure 501a, which is used to connect with the thorn external catheter <NUM>, so as to control the movement of the thorn external catheter <NUM> relative to the thorn inner catheter <NUM>. The first control structure 501a can be a knob, which is connected with the thorn inner catheter <NUM> through a worm wheel structure. Of course, those skilled in the art can also use other mechanical or electric structures to control the thorn external catheter <NUM>, which is not limited by the present invention.

As shown in <FIG>, the second catheter assembly <NUM> comprising a second fixing head <NUM>, a valve stent external catheter <NUM> and a valve stent inner catheter <NUM>. Wherein, the proximal ends of the valve stent external catheter <NUM> and the valve stent inner catheter <NUM> are respectively connected with the second control part <NUM>. The valve stent inner catheter <NUM> is provided inside the valve stent external catheter <NUM>, that is, the valve stent external catheter <NUM> is provided on the valve stent inner catheter <NUM>. The second fixing head <NUM> is fixedly connected with the valve stent inner catheter <NUM>. The second control part <NUM> also has a second control structure 502a for connecting with the valve stent external catheter <NUM>, so as to control the movement of the valve stent external catheter <NUM> relative to the valve stent inner catheter <NUM>. The second control structure 502a can be a knob, which is connected with the valve stent inner catheter <NUM> through a worm gear structure. Of course, those skilled in the art can also use other mechanical structures or electric structures to realize the control of the valve stent external catheter <NUM>, which is not limited by the present invention.

As shown in <FIG>, the thorn external catheter <NUM> and the thorn inner catheter <NUM> are connected to the first control part <NUM> through the second control part <NUM>, and the thorn external catheter <NUM> and the thorn inner catheter <NUM> can move with respect to the second control part <NUM> under the drive of the first control part <NUM>. It can be understood that the distance between the second control part <NUM> and the first control part <NUM> changes according to the relative movement of the two control parts. In addition, the first control part <NUM> has a hollow channel for the guide wire <NUM> to pass through.

As shown in <FIG>, when the thorn structure <NUM> is loaded into the first catheter assembly <NUM>, the thorn lug <NUM> of the thorn structure <NUM> is against the first fixing head <NUM>, and the thorn external catheter <NUM> is wrapped around the outside of the thorn stent <NUM>, exposing the thorn <NUM> (shown in <FIG>). When the valve stent <NUM> is loaded into the second catheter assembly <NUM>, the valve stent lug <NUM> of the valve stent <NUM> is against the second fixing head <NUM>, and the valve stent external catheter <NUM> is wrapped around the outside of the valve stent <NUM>.

The valve prosthesis in the above-mentioned embodiment can reduce the diameter of the delivery catheter and the size of the valve stent by manufacturing and implanting the valve stent and the thorn structure separately, so as to facilitate the clinical implanting through the aortic arch or through the curved path of the mitral femoral vein, thus greatly reducing the delivery difficulty and the risk of vascular injury, thus effectively avoiding the risk of complications. In addition, the prick structure of the mechanical stent can effectively solve the problem that the existing valve stent cannot reach the ideal bending angle due to the bending angle fixation, and effectively avoid the risk of fracture in the manufacturing process and fatigue fracture in the human body caused by the large bending angle and deformation, so as to greatly improve the production efficiency. It can also effectively reduce production costs.

<FIG> is a schematic view illustrating the structure when the delivery device is loading. As shown in <FIG>, when loading and releasing the valve prosthesis with the delivery device, the valve prosthesis can be implanted step by step loading and releasing, specifically:.

In the above-mentioned embodiment, by loading the thorn structure and the valve stent into the same delivery system step by step, and when the valve stent is released but the valve stent lug is not completely separated from the delivery device, that is, when the valve stent lug is still connected with the fixing head on the delivery device, the thorn structure is released, because the valve leaf (i.e. artificial valve) fixed on the valve stent has begun to work instead of the primary valve leaf, so there is enough time for the release of thorns. After the thorns are anchored stably, the thorn structure is released completely, and then the valve stent is released continuously until the valve stent is separated from the delivery device, and the delivery device is withdrawn, so as to complete the implantation of the cardiac valve prosthesis.

In a summary, the cardiac valve prosthesis, the delivery device and the method of loading and releasing the cardiac valve prosthesis recorded in the embodiment of the present invention can effectively reduce the size of the valve stent and the delivery catheter of the delivery device, enhance the stability of the fixation by manufacturing and implanting and releasing the main body of the valve stent (i.e. the valve stent <NUM>) and the anchoring structure (i.e. the thorn structure <NUM>) separately. Moreover, the thorn made of degradable materials can effectively avoid the complications caused by permanent invasive fixation and the risk of fracture of the thorn structure.

The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, all possible combinations of the technical features in the above embodiments are not described. However, as long as the combination of these technical features does not conflict, it should be considered as the scope of the description.

Claim 1:
A cardiac valve prosthesis, comprising:
an expandable valve stent (<NUM>) provided with multiple fixing holes (<NUM>);
an artificial valve (<NUM>) provided on the valve stent (<NUM>); and
a thorn structure (<NUM>) comprising an expandable thorn stent (<NUM>) and multiple thoms (<NUM>);
wherein, the multiple thorns (<NUM>) are provided on the thorn stent (<NUM>),
the size of the thorn stent (<NUM>) in a fully expanded state is greater than or equal to the size of the valve stent (<NUM>) in a fully expanded state,
the position of the multiple thorns (<NUM>) on the thorn stent (<NUM>) matches the position of the fixing holes (<NUM>) on the valve stent (<NUM>), and the size of the multiple thorns (<NUM>) on the thorn stent (<NUM>) is smaller than the size of the fixing holes (<NUM>) on the valve stent (<NUM>), such that, when the cardiac valve prosthesis is implanted into a cardiac chamber, the multiple thorns (<NUM>) pass through the multiple fixing holes (<NUM>) and penetrate tissue in the cardiac chamber so as to fix the valve stent (<NUM>),
and wherein the thorn stent (<NUM>) is a mesh structure composed of multiple diamond-shaped grids or the thorn stent (<NUM>) comprises multiple connecting rods (<NUM>) connected end to end to form a closed chain structure, wherein any two adjacent connecting rods form a V-shaped structure, and wherein the multiple thoms (<NUM>) and the multiple connecting rods (<NUM>) are integrally formed.