Ball expansion type artificial valve prosthesis with barbs, transcatheter valve replacement system and use method

Abstract

The invention belongs to the field of medical apparatus and instruments, and particularly relates to a ball-expansion type artificial valve prosthesis with barbs, a transcatheter valve replacement system and a using method, and the ball-expansion type artificial valve prosthesis comprises an artificial valve, a valve support and an anchoring device; the artificial valve is arranged in the valve stent, and the anchoring device is arranged around the valve stent; the valve stent is of a hollow net structure, is manufactured by processing a rigid metal pipe and has compressive deformation; barbs extending outwards are arranged on the anchoring device, and the anchoring device is made of shape memory alloy and has metal memorability; and a biocompatible polymeric membrane is arranged on the outer surface or the inner surface of the valve stent. Compared with the prior art, the defect that in the prior art, a balloon dilatation artificial valve prosthesis is difficult to stably anchor in non-calcified valve lesions is overcome.

Description

Technical Field

[0001] The invention belongs to the field of medical devices, and in particular relates to a barbed ball-expandable artificial valve prosthesis and a transcatheter valve replacement system and a use method. Background Art

[0002] The valves are between the atria (chambers) of the heart, including the aortic valve connecting the left ventricle and the aorta, the pulmonary valve connecting the right ventricle and the pulmonary artery, the mitral valve connecting the left atrium and the left ventricle, and the tricuspid valve connecting the right atrium and the right ventricle. Each of them opens or closes passively to ensure that blood circulates in one direction.

[0003] For example, calcification, stenosis, insufficiency and regurgitation of the aortic valve, stenosis and insufficiency of the mitral valve are common valvular diseases. Transcatheter valve replacement is an emerging treatment for this type of disease. However, the existing valve prostheses are mostly used for patients with stenotic valves. The calcified and stenotic valves of these patients can provide sufficient support and friction for the valve prostheses, thereby preventing the displacement of the valves after replacement. In cases such as aortic valve regurgitation, the native valve has no calcified masses or stenosis, so the traditional artificial valve device that relies on radial force support and anchoring can easily lead to problems such as movement after anchoring.

[0004] At present, there are two main structural forms of TAVR valves in the mainstream market: self-expanding valves and balloon-expandable valves. Balloon-expandable valves are widely used because of their strong radial support, short valve frame, and the advantages of simple and precise release by slowly expanding the balloon to the working diameter. However, for valve regurgitation without calcification, it has the risk of slipping when simply relying on radial support for anchoring. Self-expanding valves have longer valve frames, which may block the coronary artery opening and affect the later coronary intervention after the implantation of artificial valves. At the same time, such valves are also prone to valve displacement in cases of valve regurgitation.

[0005] CN117100458A discloses a valve prosthesis device with selectively distributed barbs, which can achieve anchoring without displacement by selectively setting barbs or protrusions as anchoring structures. CA3109642A1 discloses an artificial heart valve device, system and method, which provides a certain anchoring effect by setting spiral anchors on the periphery of the frame structure. However, the above structure is only used for valve prostheses of atrioventricular valves (mitral valve, tricuspid valve), and the structure, function and action mode of atrioventricular valves are different from those of aortic valves and pulmonary valves. Therefore, the above scheme is difficult to be used in the balloon-expandable valve prostheses of aortic valves and pulmonary valves.

[0006] CN105125322A discloses a novel artificial valve prosthesis, which provides additional support through the arch and realizes anchoring with the barbs provided at the lower end. However, the stent of this solution is made of shape memory alloy as a whole, which may be deformed by pressure during use and cause failure, and the barbs may also move during the deformation of the stent under pressure and damage the native valve.

[0007] In view of the foregoing, there exists a need for further improved devices, systems and methods for implantation and anchoring of prosthetic heart valves and collapsible prosthetic heart valve devices, particularly balloon-expandable heart valves, suitable for use in valvular disease without calcification and stenosis. Summary of the invention

[0008] The purpose of the present invention is to solve at least one of the above problems and to provide a barbed balloon-expandable artificial valve prosthesis and a transcatheter valve replacement system to address the deficiency that the balloon-expandable artificial valve prosthesis in the prior art is difficult to be firmly anchored in non-calcified valvular lesions; this solution achieves effective radial support of the valve stent and firm anchoring of the valve prosthesis by the anchoring device through a split design of the valve stent and the anchoring device.

[0009] The purpose of the present invention is achieved through the following technical solutions:

[0010] The first aspect of the present invention discloses a barbed ball-expandable artificial valve prosthesis, comprising an artificial valve, a valve support and an anchoring device;

[0011] The artificial valve is arranged inside the valve stent, and the anchoring device is arranged around the outer surface of the valve stent;

[0012] The valve stent is a hollow mesh structure, and the valve stent is made by processing a rigid metal pipe and has compression deformation properties;

[0013] The anchoring device is provided with barbs extending outward, and the anchoring device is made of shape memory alloy and has metal memory.

[0014] The outer surface or the inner surface of the valve support is provided with a biocompatible polymer film.

[0015] The anchoring device and the valve stent body are usually cylindrical in structure according to the shape of the blood vessel, and the diameters of the two are similar, so that after they are fully expanded, the overlapping parts of the two are tightly attached to each other.

[0016] Preferably, the anchoring device is an anchoring bracket;

[0017] The anchoring bracket is a hollow mesh structure, and the barbs are distributed on the outer surface of the anchoring bracket;

[0018] The valve stent is provided with a connecting protrusion at the end, and at least one end of the anchoring stent is connected to the valve stent via the connecting protrusion.

[0019] Preferably, one end of the anchoring stent is connected to one end of the valve stent, the other end of the anchoring stent is a free end, and the anchoring stent does not overlap with the valve stent.

[0020] Preferably, the barbs are arranged obliquely, and form an acute angle with the central axis of the anchoring device, so that they can obliquely penetrate into the native valve, and cooperate with multi-row and multi-site anchoring to further improve the effect of stable anchoring and play a role in axial anti-displacement.

[0021] Preferably, the anchoring device is an axisymmetric structure, and the barbs on both sides of the symmetry axis are arranged toward or away from the symmetry axis. The anchoring device under this structure can have barbs facing in opposite directions, so that when the anchoring device is anchored in the tissue, a two-way anchoring can be formed, further avoiding the anchoring device from failing due to continuous flow and impact of the fluid.

[0022] Therefore, there are two situations for the orientation of the barbs on the anchoring device: 1) all barbs are in the same direction, all inclined upward or downward; 2) the barbs are arranged in blocks of the anchoring device (such as on both sides of the symmetry axis), the orientation of the barbs in a single block is consistent, and the orientation of the barbs between blocks may be different.

[0023] Preferably, the tip of the barb is a double-bevel structure or a single-bevel structure. The double-bevel structure forms an isosceles triangle at the end of the barb, with the tip located on the midline of the barb; the single-bevel structure forms a right-angled triangle at the end of the barb, with the tip located on one side of the barb; in comparison, the single-bevel structure has a smaller and sharper angle, so that the barb can more easily penetrate the tissue.

[0024] The barbs are generally in the shape of oblique spikes with sharp ends, and their short rod-like structure allows them to be distributed on the sides and nodes of the anchoring bracket.

[0025] Preferably, the units in the hollow mesh structure are hexagonal or rhombic.

[0026] Preferably, the valve stent is made of cobalt-chromium alloy or stainless steel. The valve stent is made of a rigid metal tube (without morphological memory) of the corresponding material by laser cutting. The hollow mesh structure formed by cutting makes the valve stent have a certain degree of compression deformation, and can be compressed into a strip-like shape by external force, and then can be compressed outside the balloon and inside the delivery catheter during use. After being released and restored to a straight tube, it has a rigid structure and can keep the structure from collapsing.

[0027] Preferably, the anchoring device is made of nickel-titanium alloy. The anchoring device has metal memory and can be compressed and fitted to the surface of the valve stent and pressed into the delivery catheter (the anchoring device is parallel to the central axis of the valve stent to prevent the barbs from damaging the delivery catheter). After being released from the delivery catheter, the barbs on the anchoring device can quickly return to their original state, and further under the expansion of the balloon, the anchoring device body can expand and recover accordingly. The anchoring device is formed by laser cutting, and the barbs arranged thereon are cut and formed integrally with the anchoring device.

[0028] Preferably, the artificial valve is a biological valve, such as a tri-leaf or multi-leaf artificial valve made of bovine pericardium or porcine pericardium. The artificial valve and the valve support together constitute a valve structure that can control the unidirectional flow of fluid, and the biocompatible polymer film thereon can ensure that the valve structure is sealed to prevent paravalvular leakage.

[0029] The second aspect of the present invention discloses a transcatheter valve replacement system, comprising any of the above-described barbed ball-expandable artificial valve prostheses;

[0030] Also includes:

[0031] Balloon, used to expand the balloon-expandable artificial valve prosthesis;

[0032] A compression and gripping device, used for compressing and loading the balloon-expandable artificial valve prosthesis onto the outside of the balloon;

[0033] A delivery device is used to deliver a balloon loaded with a balloon-expandable artificial valve prosthesis to a target location.

[0034] The balloon is a cylindrical hollow structure made of polymer material, with a thin tube connected to its proximal end for filling and discharging fluid. Injecting liquid into the balloon through the tube can cause the balloon to expand and inflate, thereby expanding the balloon-expandable artificial valve prosthesis. The injected liquid is then extracted through the tube to deflate the balloon, thereby completing the separation of the balloon and the valve prosthesis.

[0035] A third aspect of the present invention discloses a method for using the transcatheter valve replacement system as described above, comprising the following steps:

[0036] The balloon-expandable artificial valve prosthesis is compressed and loaded onto the outside of the balloon through a compression and gripping device, and the balloon loaded with the balloon-expandable artificial valve prosthesis is placed into a delivery device; after the balloon loaded with the balloon-expandable artificial valve prosthesis is guided to the target position along the guide wire in the delivery device, the delivery device is withdrawn to allow for subsequent release of the balloon-expandable artificial valve prosthesis; liquid is then injected into the balloon to expand the balloon, and the balloon-expandable artificial valve prosthesis loaded onto the outside of the balloon is caused to expand to a target size, so that the valve stent forms structural support and the anchoring device forms an anchor; the liquid in the balloon is discharged to cause the balloon to shrink and separate from the balloon-expandable artificial valve prosthesis, and the balloon and the delivery device are completely withdrawn.

[0037] It should be noted that, since the valve stent of the balloon-expandable artificial valve prosthesis is made of rigid material, it is inelastic, and has a dense and thick network structure, while the anchoring device (anchoring stent) has a sparse network structure and thin connecting beams, there is a mutual antagonistic force between the valve stent and the anchoring device after compression and gripping, and the expansion force of the anchoring device itself is weak and cannot support the expansion and deployment of the valve stent. Therefore, after the delivery device (delivery catheter) is withdrawn and before the balloon is filled with liquid, the two can still be loaded on the balloon in the form of thin strips, and will expand and deploy with the expansion of the balloon.

[0038] The working principle of the present invention is:

[0039] The valve prosthesis is deployed or released and re-expanded to its full operational size after being delivered to a designated target via a delivery catheter (device); the designated target is usually at or near the annulus of the patient's heart valve that will be replaced by the artificial valve prosthesis.

[0040] The approach includes two methods: transapical approach and transfemoral approach to reach the main valve position.

[0041] The valve prosthesis is loaded onto the balloon through a crimping device, and then loaded as a whole into a delivery catheter, and then the delivery device is used to reposition the heart valve prosthesis to the target position. After the valve prosthesis is delivered to the target position along the guide wire, the delivery catheter that crimps the valve stent is slowly withdrawn away from the valve annulus position, and the barbs on the anchoring device naturally restore the structural shape while the valve stent and the anchoring device remain stationary; by injecting liquid into the balloon, the balloon gradually expands and expands the artificial valve and valve stent to the target size. The expanded valve stent is anchored to the target annulus and annulus position through radial support force and the barb structure on its outer surface. After evaluating the functionality of the heart valve prosthesis, the heart valve prosthesis is completely released and separated from the delivery device.

[0042] Compared with the prior art, the present invention has the following beneficial effects:

[0043] The surface of the balloon-expandable valve stent is provided with an anchoring device, which is provided with barbs, which strengthens the contact friction between the balloon-expandable valve and the target valve position, and also strengthens the radial support force; therefore, the balloon-expandable artificial valve prosthesis can be used for a wider range of lesions, such as valvular regurgitation and other lesions with less calcification. Secondly, the balloon-expandable artificial valve prosthesis still has the advantages of the balloon-expandable valve, simple operation, short stent, easy to achieve adjustable bending of the delivery system, etc., and overcomes the easy sliding problem of conventional balloon-expandable valves.

[0044] The use of a superelastic nickel-titanium memory alloy stent and a valve balloon-expandable cobalt-chromium alloy stent can better solve the problem of cobalt-chromium alloy barb molding process, strengthen the radial support force of the valve stent, solve the problem of the valve stent slipping in the blood vessel or valve ring due to insufficient contact friction, and provide stable anchoring for the valve prosthesis. At the same time, the barbs of the memory alloy are elastic and can be compressed during loading, which reduces the delivery size and reduces human damage. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] Figure 1 It is a schematic structural diagram of the ball-expandable artificial valve prosthesis of Example 1 at a first viewing angle (side view);

[0046] Figure 2 Schematic diagram of the structure of the ball-expandable artificial valve prosthesis of Example 1 at a second viewing angle (top view);

[0047] Figure 3 It is a schematic cross-sectional view of the structure of the ball-expandable artificial valve prosthesis of Example 1;

[0048] Figure 4 Schematic diagram of the structure of the ball-expandable artificial valve prosthesis of Example 1 at a third viewing angle (bottom view);

[0049] Figure 5 It is a schematic structural diagram of a unit structure of a valve stent in a ball-expandable artificial valve prosthesis;

[0050] Figure 6 It is a schematic diagram of the structure of a valve stent in a balloon-expandable artificial valve prosthesis;

[0051] Figure 7 It is a schematic diagram of the structure of an artificial valve in a ball-expandable artificial valve prosthesis;

[0052] Figure 8 Schematic diagram of the structure of the anchoring stent in the ball-expandable artificial valve prosthesis of Example 1;

[0053] Fig. 9 for Figure 8 A schematic diagram of the partially enlarged structure of the barbs on the middle anchoring bracket;

[0054] Fig.10 Another structural schematic diagram of an anchoring stent in a balloon-expandable artificial valve prosthesis;

[0055] Fig.11 for Fig.10 A schematic diagram of the structure of the anchor bracket from another perspective;

[0056] Fig.12 for Fig.11 A schematic diagram of a partially enlarged structure of an anchoring bracket;

[0057] Fig.13 A schematic diagram of a structure in which barbs are provided on the anchoring stent portion of a ball-expandable artificial valve prosthesis;

[0058] Fig.14 It is a schematic diagram of the structure in which the barb has a double-bevel structure;

[0059] Fig.15 It is a schematic diagram of the structure in which the barb (located in the middle) is a single bevel structure;

[0060] Fig.16 It is a schematic diagram of the structure in which the barb (located at the end) is a single bevel structure;

[0061] Fig.17 Schematic diagram of the separation structure of the ball-expandable artificial valve prosthesis (the anchoring stent is connected to the lower part of the valve stent) of Example 2;

[0062] Fig.18 Schematic diagram of the combined structure of the ball-expandable artificial valve prosthesis (the anchoring stent is connected to the lower part of the valve stent) of Example 2;

[0063] Fig.19 Schematic diagram of the extension direction of the barbs, wherein (a) is all inclined toward the upper side, (b) is all inclined toward the lower side, and (c) is the upper half inclined toward the upper side and the lower half inclined toward the lower side;

[0064] Fig. 20 Schematic diagram of the structure of the ball-expandable artificial valve prosthesis (the anchoring device is an anchor plate) of Example 3;

[0065] Fig.21 It is a schematic diagram of the structure of the valve stent of the ball-expandable artificial valve prosthesis when it is pressed and loaded;

[0066] In the figure: 1-artificial valve; 2-valve stent; 21-connection protrusion; 22-connection interface; 3-anchoring device; 31-anchoring stent; 4-barb. DETAILED DESCRIPTION

[0067] The present invention is described in detail below with reference to the accompanying drawings and specific embodiments.

[0068] Example 1

[0069] A ball-expandable artificial valve prosthesis with barbs 4, such as Figure 1-16 As shown, it includes an artificial valve 1, a valve stent 2 and an anchoring device 3;

[0070] The artificial valve 1 is arranged inside the valve stent 2, and the anchoring device 3 is arranged around the outer surface of the valve stent 2;

[0071] The valve support 2 is a hollow mesh structure, and the valve support 2 is made by processing a rigid metal pipe and has compression deformation properties;

[0072] The anchoring device 3 is provided with a barb 4 extending outward, and the anchoring device 3 is made of shape memory alloy and has metal memory;

[0073] The outer surface or the inner surface of the valve support 2 is provided with a biocompatible polymer film.

[0074] More specifically, in this embodiment:

[0075] A ball-expandable artificial valve prosthesis with a barbed 4-type structure, which can be delivered to the original valve position of the human body through a delivery catheter to replace the original valve of the human body. Figure 1-9 As shown, the valve prosthesis is composed of four parts, a three-leaflet or multi-leaflet artificial valve 1, a valve stent 2 and an anchoring device 3 (an anchoring stent 31 with barbs 4 in this embodiment).

[0076] A three-leaflet or multi-leaflet artificial valve 1 (made of biological materials such as bovine pericardium or porcine pericardium, etc.) is sutured and installed inside the valve stent 2. The artificial valve 1 can shrink or curl as the main stent shrinks to reduce its circumferential size and can then be loaded into a delivery catheter (device).

[0077] The valve stent 2 is made of a non-shape memory, rigid metal tube (such as cobalt-chromium alloy or stainless steel) through laser cutting to form a straight cylindrical stent with a hollow mesh structure and composed of rhombus or hexagonal units. Since the unit chambers are rhombus and hexagonal, the valve stent 2 has a certain degree of compression deformation, so the valve stent 2 can be compressed into a strip by external force, such as Fig.21 When in use, the valve stent 2 is compressed on a balloon, and after being delivered to a designated position in the body, the valve stent 2 is expanded by the balloon to restore it to a straight cylindrical shape. Since the expanded valve stent 2 is a rigid structure, the valve stent 2 can always maintain this shape without collapse. The valve stent 2 can be further divided into an upper end, a middle part and a lower end, as shown in FIG. Figure 6 As indicated in the figure, it has a connection convex point 21 (or protrusion) at the upper or lower end, which is characterized by a hole structure and can be mechanically connected to both ends or one end of the anchoring stent 31. The artificial valve 1 and its valve stent 2 form a valve valve structure that can control the unidirectional flow of fluid. The valve structure is arranged inside the valve stent 2, so that the valve stent 2 is sutured with a biocompatible polymer film on the inner surface or outer surface to ensure sealing and prevent paravalvular leakage; further, it can also be considered to suture a biocompatible polymer film on the outer surface or inner surface of the anchoring stent 31 to further improve the sealing effect.

[0078] as follows Figure 8 , 9 as well as Figure 10-12 As shown, the anchoring bracket 31 is made of nickel-titanium alloy with shape memory effect through laser cutting to form a hollow mesh structure, the unit has a diamond or hexagonal structural feature, and the mesh connecting rod surface also has a barb 4 structural feature. The anchoring bracket 31 can be divided into the upper end, the lower end and the barb 4 and other basic structural features, such as Figure 8 As indicated in , the upper end or the lower end is mechanically connected to the upper end or the lower end of the valve support 2 by means of sutures, rivets or welding. The anchoring support 31 has metal memory and can be compressed into a small pipe and can return to its original shape after being released from the pipe.

[0079] as follows Figure 8 and Fig.13 The barbs 4 provided on the anchor bracket 31 can be distributed on the entire bracket surface, or on a part thereof, such as the upper or lower half. The barbs 4 and the anchor bracket 31 are cut as one piece, and are sharp oblique barb-like structures. The short rod-shaped barbs 4 can be distributed on the side of the connecting rod of the anchor bracket 31 (the side of the mesh structure), or on the node position of the connecting rod of the anchor bracket 31 (the intersection of the mesh structure); the direction pointed by the tip of the barb 4 forms an acute angle with the central axis of the anchor bracket 31, and the tip of the barb 4 is directed toward the radial direction of the outer side of the circumference of the anchor bracket 31, and is obliquely stabbed upward or downward, and is distributed in multiple rows. After the valve stent 2 is expanded to the target diameter by the balloon, the barbs 4 on the outer surface of the anchoring stent 31 can obliquely penetrate into the tissue at the valve position, thereby having an axial anti-displacement effect; in addition, since the entire anchoring stent 31 is made of memory metal, the barbs 4 can be compressed to be parallel to the central axis of the anchoring stent 31 (i.e., received into the anchoring stent 31) during loading and transportation, so as to facilitate the loading of the compressed anchoring stent 31 into a small pipe without damaging the loading pipe.

[0080] In other embodiments, the orientation of the barbs 4 can also be arranged in blocks (such as being divided into upper and lower sides according to the axis of symmetry), so that the barbs in some blocks are inclined toward the upper side, and the barbs in the remaining blocks are inclined toward the lower side. For example, the barbs 4 in the upper part of the anchoring bracket 31 are all inclined toward the upper side, and the barbs 4 in the lower part of the anchoring bracket 31 are all inclined toward the lower side. Among them, the barbs 4 facing one side are mainly to facilitate the withdrawal of the delivery catheter, and the barbs 4 with different orientations are to be suitable for different valve positions (mitral valve and aortic valve, apex and femoral vein access). Specifically, as Fig.19As shown, according to the needs of the implantation position, the barbs 4 can generally be divided into three tilted states, including: (a) the barbs 4 are all facing the upper side (the valve blood flow inflow end), which is suitable for implantation at the mitral valve position; (b) the barbs 4 are all facing the lower side (the valve blood flow outflow end), which is suitable for implantation at the aortic valve position; (c) the upper part of the barbs 4 are facing the upper side (the valve blood flow inflow end), and the lower part of the barbs 4 are facing the lower side (the valve blood flow outflow end), which is suitable for implantation at both the aortic valve position and the mitral valve position.

[0081] Fig.14 , 15 16 shows the situation where the barbs 4 are distributed at the node intersection position or at the side position of the bracket connecting rod, and the barbs 4 can be provided with a double bevel structure at the tip ( Fig.14 ) and single bevel structure ( Fig.15 , 16 ), the barb 4 in the single-bevel structure has a smaller tip bevel angle, which can increase the sharpness of the barb 4 and make it easier to penetrate the tissue.

[0082] The connection between the anchoring bracket 31 and the valve bracket 2: one end of the anchoring bracket 31 is connected to the connection protrusion 21 at one end of the internal valve bracket 2 by mechanical connection methods such as suturing, inlaying, riveting or sleeve interference gripping. There are three specific connection methods: first, the upper end of the anchoring bracket 31 is connected to the connection protrusion 21 at the upper end of the valve bracket 2, and the other end is free; second, the lower end of the anchoring bracket 31 is connected to the connection protrusion 21 at the lower end of the valve bracket 2, and the other end is free; third, one end of the anchoring bracket 31 is connected to the connection protrusion 21 at one end of the valve bracket 2, and the other end of the anchoring bracket 31 is fixedly connected to a grid node and a node rod in a certain area of ​​the valve bracket 2 at multiple points.

[0083] The balloon-expandable artificial valve prosthesis, together with a balloon, a compression gripping device and a delivery device, forms a transcatheter aortic valve replacement system, which can be used in transcatheter aortic valve replacement surgery.

[0084] The balloon is a hollow cylindrical air-sac-like structure made of polymer material. A small tube is connected to the proximal end of the balloon. Liquid is injected into the balloon from the tube to cause the balloon to expand and then expand the main stent compressed on the balloon to make it fully expanded. Afterwards, when the balloon is deflated, the balloon and the valve stent 2 can be separated.

[0085] The compression and gripping device may adopt an existing device, the purpose of which is to compress the balloon-expandable artificial valve prosthesis and install it outside the balloon; the delivery device may adopt a delivery catheter, which is used to guide and deliver the balloon loaded with the balloon-expandable artificial valve prosthesis to a designated target position.

[0086] The artificial valve prosthesis is delivered to the designated target through a delivery catheter (device) and then unfolded or released to expand back to the full operational size; the designated target is usually at or near the annular gap of the patient's heart valve to be replaced by the artificial valve prosthesis. The use of a delivery catheter can firmly restrict the ball-expandable artificial valve prosthesis from the outside to always be in a compressed state during the delivery process, which not only protects the patient's internal tissue and avoids scratches, but also ensures that the connection structure between the anchoring bracket 31 and the valve bracket 2 is not affected during the delivery process, and the two will not loosen or slide relative to each other; in this way, it can be ensured that when the ball-expandable artificial valve prosthesis is delivered to the designated position, its structure can maintain the same state as after compression and gripping, and can be expanded and restored according to the predetermined structure and method.

[0087] Since the anchoring stent 31 is made of shape memory alloy, the barbs 4 on the anchoring stent 31 will naturally restore their structure and shape after the external (the catheter of the delivery device) restriction is removed. Since the mesh structure of the anchoring stent 31 is relatively sparse and the connecting beams are thin, the network structure of the valve stent 2 is denser and thicker, and the valve stent 2 is made of rigid metal, there is a certain mutual antagonism between the two after being clamped, and the expansion force of the anchoring stent 31 itself is relatively weak and cannot support the expansion and deployment of the valve stent 2. Therefore, the anchoring stent 31 and the valve stent 2 remain in a clamped state; then the balloon is expanded by liquid injection, which drives the expansion and deployment of the valve stent 2 and the anchoring stent 31, so that structural restoration, support and anchoring can be achieved. In order to ensure stable overlap between the anchoring stent 31 and the valve stent 2 and basically keep the movements consistent, such as Figure 2 As shown, the anchoring stent 31 is configured as a sparser structure than the valve stent 2 (the hollow size of the anchoring stent 31 is relatively larger, and one hollow unit in the anchoring stent 31 is approximately equivalent to four hollow units in the valve stent 2), so that the initial expansion force of the anchoring stent 31 is low, thereby ensuring the structural stability and reliable connection of the anchoring stent 31 and the valve stent 2 during the expansion process; at the same time, both the anchoring stent 31 and the valve stent 2 adopt a cylindrical structure that matches the blood vessel, and the diameters of the two are similar, so that they can still remain close to each other after expansion and expansion.

[0088] In addition, in this embodiment, the anchoring stent 31 uses a rhombus-shaped unit cell and the valve stent 2 uses a hexagonal unit cell. Figure 6 , 8As shown, in addition, this embodiment also preferably adopts the following connection method: only one end (the lower end, or the upper end in other embodiments) of the anchoring bracket 31 and the valve bracket 2 is restricted. In this way, when the crimping device compresses the ball-expandable artificial valve prosthesis, the mutual displacement between the anchoring bracket 31 and the valve bracket 2 can be avoided as much as possible, and will not be due to: the connection is too tight, resulting in the mutual restriction between the anchoring bracket 31 and the valve bracket 2 so that the whole cannot be compressed, or the connection is too loose, resulting in insufficient fixing force, which is easy to cause mutual displacement and shaking and lead to failure. The structure of the valve bracket 2 after compression is generally in the shape of a slender strip.

[0089] The approach includes two methods: transapical approach and transfemoral approach to reach the main valve position.

[0090] The valve prosthesis is loaded onto the balloon by a crimping device, and loaded as a whole into the delivery catheter, and then the delivery device is used to reposition the heart valve prosthesis to the target position. After the valve prosthesis is delivered to the target position along the guide wire, the delivery catheter that crimps the valve stent 2 is slowly withdrawn away from the valve annulus position, and the barbs 4 on the anchoring stent 31 naturally restore the structural shape while the valve stent 2 and the anchoring stent 31 remain stationary; by injecting liquid into the balloon, the balloon gradually expands and expands the artificial valve 1 and the valve stent 2 to the target size. The expanded valve stent 2 is anchored to the target annulus and the annulus position by the radial support force and the barb 4 structure on its outer surface. After evaluating the functionality of the heart valve prosthesis, the heart valve prosthesis is completely released and separated from the delivery device.

[0091] Example 2

[0092] like Fig.17 , 18 As shown, the external structure of the ball-expandable artificial valve prosthesis of this embodiment (valve stent 2 + anchoring stent 31); the main difference between it and embodiment 1 is that the anchoring stent 31 is arranged at one end of the valve stent 2, specifically: the upper end of the anchoring stent 31 is connected to the lower end of the valve stent 2, the lower end of the anchoring stent 31 is a free end, and the anchoring stent 31 does not overlap with the valve stent 2, at this time, the anchoring stent 31 can be regarded as an extension of the valve stent 2. Under this structure, after the anchoring stent 31 completes the anchoring with the tissue, it is equivalent to anchoring one end of the valve stent 2; at the same time, as an extension of the valve stent 2, the anchoring stent 31 can avoid the anchoring stent 31 affecting the support of the valve stent 2 (it can also make the anchoring stent 31 avoid difficult-to-anchor positions, such as tissue calcification, hardening positions or blood vessel intersection positions), and at the same time, the anchoring stent 31 under this structure will not change the original characteristics of the ball-expandable valve.

[0093] Example 3

[0094] like Fig. 20As shown in the figure, it is the external structure of the balloon-expandable artificial valve prosthesis in this embodiment (valve stent 2 + anchoring device 3); the main difference from Embodiment 1 is that the anchoring device 3 adopts an anchoring plate, and a mutually matching "丰" - shaped structure is arranged in the middle of the anchoring plate and the middle of the valve stent 2 to realize the connection between the two; in addition, the anchoring plate is provided with protrusions along both side edges, and barbs are arranged on the protrusions so that the barbs are arranged in a staggered manner, which can provide higher bonding strength after penetration.

[0095] In summary, through the split structure, the valve stent 2 and the anchoring device 3 can select their respective suitable materials to achieve corresponding functions: the hollow reticular structure formed by the valve stent 2 enables it to have a certain compression deformability, and it can be compressed to a certain extent and loaded on the balloon and in the delivery catheter. At the same time, its rigidity enables it to form a stable support when deployed, and it is not easy to deform or collapse; the shape memory alloy used in the anchoring device 3 itself has a certain deformation ability and recovery ability, and can be loaded in the delivery catheter and released and deployed after the delivery catheter is withdrawn, so that the barbs 4 on it can firmly penetrate into the tissue; the anchoring device 3 also forms a reliable mechanical connection with the valve stent 2, thereby effectively realizing the functions of stable support and firm anchoring of the artificial valve prosthesis.

[0096] The above embodiments give an example when the artificial valve 1 is an aortic valve. In other embodiments, the artificial valve 1 can also correspondingly adopt artificial valves 1 such as mitral valve, pulmonary valve, and tricuspid valve. At this time, the overall structure and method are the same or similar to those of the above embodiments.

[0097] The above description of the embodiments is for the convenience of those of ordinary skill in the art to understand and use the invention. Obviously, those skilled in the art can easily make various modifications to these embodiments and apply the general principles described herein to other embodiments without creative labor. Therefore, the present invention is not limited to the above embodiments, and the improvements and modifications made by those skilled in the art without departing from the scope of the present invention according to the disclosure of the present invention should be within the protection scope of the present invention.

Claims

1. A barbed ball-expandable artificial valve prosthesis, characterized in that: It comprises an artificial valve (1), a valve support (2) and an anchoring device (3); The artificial valve (1) is arranged inside the valve support (2), and the anchoring device (3) is arranged around the outer surface of the valve support (2); The valve support (2) is a hollow mesh structure, and the valve support (2) is made by processing a rigid metal pipe and has compressive deformation properties; The anchoring device (3) is provided with barbs (4) extending outward, and the anchoring device (3) is made of shape memory alloy and has metal memory. The outer surface or inner surface of the valve support (2) is provided with a biocompatible polymer film.

2. The barbed ball-expandable artificial valve prosthesis according to claim 1, characterized in that: The anchoring device (3) is an anchoring bracket (31); The anchoring bracket (31) is a hollow mesh structure, and the barbs (4) are distributed on the outer surface of the anchoring bracket (31); The hollow mesh structure of the anchoring stent (31) is thinner than the hollow mesh structure of the valve stent (2), and the valve stent (2) is thicker than the anchoring stent (31); The valve support (2) is provided with a connection protrusion (21) at the end, and at least one end of the anchoring support (31) is connected to the valve support (2) via the connection protrusion (21).

3. The barbed ball-expandable artificial valve prosthesis according to claim 2, characterized in that: One end of the anchoring stent (31) is connected to one end of the valve stent (2), the other end of the anchoring stent (31) is a free end, and the anchoring stent (31) and the valve stent (2) do not overlap.

4. A barbed ball-expandable artificial valve prosthesis according to any one of claims 1 to 3, characterized in that: The barbs (4) are arranged obliquely, and the barbs (4) form an acute angle with the central axis of the anchoring device (3).

5. The barbed ball-expandable artificial valve prosthesis according to claim 4, characterized in that: The anchoring device (3) is an axisymmetric structure, and the barbs (4) on both sides of the symmetry axis are arranged toward or away from the symmetry axis.

6. A barbed ball-expandable artificial valve prosthesis according to any one of claims 1 to 3, characterized in that: The tip of the barb (4) is a double-bevel structure or a single-bevel structure.

7. A barbed ball-expandable artificial valve prosthesis according to any one of claims 1 to 3, characterized in that: The units in the hollow mesh structure are hexagonal or rhombus-shaped.

8. A barbed ball-expandable artificial valve prosthesis according to any one of claims 1 to 3, characterized in that: The valve support (2) is made of cobalt-chromium alloy or stainless steel.

9. A barbed ball-expandable artificial valve prosthesis according to any one of claims 1 to 3, characterized in that: The anchoring device (3) is made of nickel-titanium alloy.

10. The barbed ball-expandable artificial valve prosthesis according to claim 1, characterized in that: The artificial valve (1) is a biological valve.

11. A transcatheter valve replacement system, characterized in that: A method comprising: comprising a barbed ball-expandable artificial valve prosthesis as described in any one of claims 1 to 10; Also includes: Balloon, used to expand the balloon-expandable artificial valve prosthesis; A compression and gripping device, used for compressing and loading the balloon-expandable artificial valve prosthesis onto the outside of the balloon; A delivery device is used to deliver a balloon loaded with a balloon-expandable artificial valve prosthesis to a target location.

12. A method for using the transcatheter valve replacement system according to claim 11, characterized in that: The steps include: The balloon-expandable artificial valve prosthesis is compressed and loaded onto the outside of the balloon by means of a compression and gripping device, and the balloon loaded with the balloon-expandable artificial valve prosthesis is placed into a delivery device; after the balloon loaded with the balloon-expandable artificial valve prosthesis is guided to a target position along a guide wire in the delivery device, the delivery device is withdrawn to allow for subsequent release of the balloon-expandable artificial valve prosthesis; liquid is then injected into the balloon to expand the balloon, and the balloon-expandable artificial valve prosthesis loaded onto the outside of the balloon is caused to expand to a target size, so that the valve support (2) forms a structural support, and the anchoring device (3) forms an anchoring; the liquid in the balloon is discharged to cause the balloon to shrink and separate from the balloon-expandable artificial valve prosthesis, and the balloon and the delivery device are completely withdrawn.

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