Ball expansion type artificial valve prosthesis with elastic barbs

Abstract

The invention relates to the field of medical instruments, and discloses a ball expansion type artificial valve prosthesis with elastic barbs, which comprises an artificial valve, a valve stent and an anchoring plate, the artificial valve is arranged in the valve stent, and the anchoring plate is arranged around the outer surface of the valve stent; the valve stent is of a hollowed-out net structure, and the valve stent has compression deformability; barbs extending outwards are arranged on the anchoring plate, and a biocompatible polymeric membrane is arranged on the outer surface or the inner surface of the valve stent. 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; according to the scheme, through the split type design that the rigid valve short support and the elastic anchoring device are combined, effective supporting and stable anchoring of the valve support are achieved, and small-size and bending-adjustable conveying is achieved.

Description

Technical Field

[0001] This application relates to the field of medical devices, and more specifically, to a bulbous artificial valve prosthesis with elastic barbs. Background Technology

[0002] Transcatheter valve replacement (TCV) is an emerging treatment for heart valve disease, with transcatheter aortic valve replacement (TAVR) being a prime example. However, current valve prostheses are primarily used for patients with valvular stenosis. In these patients, the calcified and stenotic valve provides sufficient support and friction for the prosthesis, preventing valve displacement after replacement. In cases such as aortic regurgitation, where the patient's own valve lacks calcification and stenosis, traditional radial force-supported anchored artificial valve devices are prone to problems such as post-anchoring displacement.

[0003] Currently, the main TAVR valves on the market are self-expanding valves and balloon-expanding valves. Balloon-expanding valves are widely used due to their strong radial support, short valve frame, and adjustable delivery system. The balloon expands slowly to the working diameter, offering advantages such as simple and precise release. However, for non-calcified valvular regurgitation, relying solely on radial support for anchoring carries the risk of slippage. Self-expanding valves, on the other hand, have a longer valve frame, making it impossible to adjust the delivery system. The valve prosthesis is difficult to keep coaxial with the body's valve annulus, hindering precise implantation. Furthermore, such valves are prone to displacement in non-calcified cases.

[0004] In view of the foregoing, there is a need to design a balloon-expandable valve prosthesis with a stable anchoring device to overcome the shortcomings of the two current valves, so that it can be used for valvular lesions without calcification and stenosis, and also have the advantages of balloon-expandable valves. Summary of the Invention

[0005] To address the aforementioned problems in the prior art, this invention provides a ball-expanding artificial valve prosthesis with elastic barbs. This solution, through a split design combining a rigid valve frame structure and an elastic anchoring structure, achieves effective support, stable anchoring, and small-size, adjustable-bend delivery of the valve stent.

[0006] The objective of this invention is achieved through the following technical solution:

[0007] In a first aspect, this application provides a ball-expanding artificial valve prosthesis with elastic barbs, including an artificial valve, a valve stent, and an anchoring plate;

[0008] The artificial valve is disposed inside the valve stent, and the anchoring plate is disposed around the outer surface of the valve stent;

[0009] The valve stent has a hollow mesh structure and is made of rigid metal tubing, giving it compressibility and deformability.

[0010] The anchor plate is provided with barbs extending outwards, and the anchor plate is made of shape memory alloy, which has metallic memory properties;

[0011] The outer or inner surface of the valve stent is provided with a biocompatible polymer membrane.

[0012] Preferably, the anchor plate is elongated and includes a connecting section in the middle, with the barbs distributed on both sides of the connecting section.

[0013] Preferably, the valve stent has a connection interface in the middle that matches the connecting segment. The anchor plate is connected to the valve stent through the cooperation of the connecting segment and the connection interface, and always remains parallel to the central axis of the valve stent in the axial direction. Since the unit of the valve stent is a rhomboid or hexagonal structure, the valve stent will shorten when it changes from a compressed state to an expanded state. The anchor plate and the valve stent are connected at only one point in the middle section, which allows the anchor plate not to affect the axial deformation of the valve stent.

[0014] Preferably, the barbs are inclined, and the angle between the barbs and the central axis of the anchoring plate is acute, so that they can be inserted obliquely into the original vein. Combined with multiple rows and multiple anchoring points, the effect of stable anchoring is further improved, and the effect of axial displacement resistance is achieved.

[0015] The plate in this structure can have barbs facing opposite directions, allowing for bidirectional anchoring once the anchoring plate is embedded in the tissue. This further prevents anchoring failure due to continuous fluid flow and impact. Alternatively, the barbs can be arranged in the same direction to counteract lateral displacement of the valve stent.

[0016] Preferably, the tip of the barb has a double-beveled or single-beveled structure. The double-beveled structure forms an isosceles triangle at the end of the barb, with the tip located on the center line of the barb; the single-beveled structure forms a right-angled triangle at the end of the barb, with the tip located on one side of the barb. Comparatively, the single-beveled structure has a smaller and sharper angle, allowing the barb to penetrate tissue more easily.

[0017] The barbs are generally shaped like sharp, oblique spikes, and their short, rod-like structure allows them to be distributed at any position on the surface of the anchor plate.

[0018] Preferably, there are several anchor plates, and the multiple anchor plates are evenly distributed on the outer surface of the valve stent, and the barbs are provided on the side facing away from the valve stent.

[0019] Preferably, the units in the hollow mesh structure of the valve stent are hexagonal or rhomboid, and multiple unit structures constitute a cylindrical hollow stent structure.

[0020] The valve stent is made of cobalt-chromium alloy or stainless steel. The valve stent is made of rigid metal tubing of the corresponding material (without shape memory) by laser cutting. The hollow mesh structure formed by cutting gives the valve stent a certain degree of compressibility and deformation. It can be compressed into an approximately strip shape by external force, and thus can be compressed outside the balloon and inside the delivery catheter during use. When released, it is expanded by the balloon and restored to a straight cylindrical shape with a rigid structure, which can keep the structure from collapsing.

[0021] Preferably, the anchoring plate is made of nickel-titanium alloy, which has metal memory properties. The barbs can be compressed and adhered to the surface of the valve stent and pressed into the delivery catheter, parallel to the central axis of the valve stent, thus avoiding damage to the delivery catheter by the barbs. After being released from the delivery catheter, it can quickly return to its original shape. The anchoring plate is formed by laser cutting, and the barbs on it are integrally cut with the anchoring plate.

[0022] Preferably, the artificial valve is a biological valve or a polymeric valve, such as a trileafed or multileafed artificial valve made of bovine or porcine pericardium; it can also be an artificial valve made of polymeric membrane material. The artificial valve and the valve stent together constitute a valve valve structure that can control the unidirectional flow of fluid, and the biocompatible polymeric membrane on it can ensure the sealing of the valve valve structure and prevent paravalvular leakage.

[0023] Secondly, this application provides a transcatheter valve replacement system, including a bulb-expandable prosthetic valve with elastic barbs as described above;

[0024] Also includes:

[0025] A balloon is used to inflate a bulboscopic artificial valve. The balloon is a cylindrical hollow structure made of polymer material, with a small tube connected to its proximal end for inflating and deflating fluid. Injecting fluid into the balloon through this tube causes it to expand and inflate, thus inflating the bulboscopic artificial valve. Then, the inflated fluid is withdrawn through the same tube, causing the balloon to deflate and separating from the valve prosthesis.

[0026] The compression device is used to compress and load the balloon-expandable artificial valve prosthesis onto the outside of the balloon.

[0027] The delivery device is used to transport a balloon loaded with a balloon-expandable artificial valve prosthesis to the target location. The delivery device is a long catheter made of polymer material. The balloon-expandable artificial valve prosthesis attached to the balloon is inserted into the delivery catheter and then delivered to the target location. This ensures that the barbs of the anchor plate do not damage human tissue during the delivery of the artificial valve prosthesis. The portion of the delivery catheter near the balloon-expandable artificial valve prosthesis can be equipped with an adjustable structure for bending.

[0028] Thirdly, this application provides a method of using the aforementioned transcatheter valve replacement system, comprising the following steps:

[0029] The balloon-expandable artificial valve prosthesis is compressed and loaded onto the outside of the balloon using a gripping device, and then placed into the delivery device.

[0030] After the balloon loaded with the expandable artificial valve prosthesis is guided to the target position along the guide wire in the delivery device, it is withdrawn from the delivery device to allow for the subsequent release of the expandable artificial valve prosthesis;

[0031] Fluid is then injected into the balloon to inflate it, which in turn causes the balloon-expandable artificial valve prosthesis mounted outside the balloon to expand to the target size, so that the valve stent can form structural support and the anchoring plate can form anchor.

[0032] The fluid inside the balloon is expelled, causing the balloon to contract and separate from the expandable artificial valve prosthesis, completely detaching the balloon and delivery device.

[0033] In summary, compared with the prior art, this application has the following beneficial effects:

[0034] The surface of the balloon-expandable valve stent is equipped with an anchoring plate with barbs, which enhances the contact friction between the balloon-expandable valve and the target valve position. Therefore, this balloon-expandable artificial valve prosthesis can be used for a wider range of lesions, such as lesions with less calcification, such as aortic regurgitation and mitral stenosis. Secondly, this balloon-expandable artificial valve prosthesis retains the advantages of balloon-expandable valves, such as simple operation, short stent, and easy adjustment of the delivery system, while overcoming the slippage problem of conventional balloon-expandable valves. The use of a super-elastic nickel-titanium shape memory alloy anchoring plate and a cobalt-chromium alloy stent with valve balloon expansion better solves the problem of cobalt-chromium alloy barb forming and addresses the issue of insufficient contact friction leading to slippage in the balloon-expandable stent. Simultaneously, the elastic barbs of the shape memory alloy can be compressed during loading, reducing the delivery size and minimizing injury to the patient. Attached Figure Description

[0035] Figure 1 This is a schematic diagram of the artificial valve in the embodiments of this application;

[0036] Figure 2 This is a schematic diagram illustrating the cooperation relationship between the valve stent and the anchor plate in an embodiment of this application;

[0037] Figure 3 This is a schematic diagram of the valve stent structure in the embodiments of this application;

[0038] Figure 4 This is a schematic diagram of the anchor plate structure in an embodiment of this application;

[0039] Figure 5 This is a schematic diagram of the compressed state of the ball-expanding artificial valve prosthesis with elastic barbs in the embodiments of this application.

[0040] Reference numerals: 1. Artificial valve; 2. Valve stent; 21. Upper end; 22. Middle part; 221. Connecting interface; 23. Lower end; 3. Anchor plate; 31. Connecting segment; 4. Barb. Detailed Implementation

[0041] The structure and effects of this application will be further described in detail below with reference to embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and not intended to limit it. Furthermore, it should be noted that, for ease of description, the accompanying drawings show only the parts relevant to the invention, not the entire structure.

[0042] Example: Ball-shaped artificial valve prosthesis with elastic barbs

[0043] A type of balloon-expandable artificial valve prosthesis with elastic barbs, such as Figure 1 and 2 As shown, the valve prosthesis includes a three- or multi-leaved artificial valve 1, a valve stent 2, and an anchoring plate 3. The valve prosthesis of this application can be delivered to the location of the body's native valve via a delivery catheter to replace the function of the body's native valve.

[0044] A three-leaf or multi-leaf artificial valve 1 (made of biological materials such as bovine pericardium or porcine pericardium, or a polymer membrane) is sutured and installed inside the valve stent 2. The artificial valve 1 can reduce its circumferential size by contracting or curling with the main stent, and can then be loaded into the delivery catheter (device).

[0045] like Figures 2-4As shown, the valve stent 2 is made of a rigid, non-shape-memory metal tube (such as cobalt-chromium alloy or stainless steel) through laser cutting, forming a cylindrical stent with a hollow mesh structure composed of rhomboid or hexagonal units. Because the unit chambers are rhomboid and hexagonal, the valve stent 2 has a certain degree of compressibility, allowing it to be compressed into a strip shape by external force. In practical use, the valve stent 2 is compressed onto a balloon, delivered to the designated location in the body, and then expanded back to a cylindrical shape by inflating the balloon. Because the expanded valve stent 2 is a rigid structure, it can maintain this shape without collapsing. The valve stent 2 can be further divided into an upper end 21, a middle part 22, and a lower end 23. The artificial valve 1 and the valve stent 2 form a valve valve structure that controls the unidirectional flow of fluid. This valve structure is located inside the valve stent 2; therefore, a biocompatible polymer membrane is sewn onto the inner or outer surface of the valve stent 2 to ensure a seal and prevent paravalvular leakage.

[0046] like Figures 2-4 As shown, the anchor plate 3 is made of shape memory alloy and has metallic memory properties. The anchor plate 3 has barbs 4 extending outwards, with the tips of the barbs 4 having a double-beveled or single-beveled structure. The anchor plate 3 and the valve stent 2 are assembled to form a ball-expanding artificial valve prosthesis. The middle part of the anchor plate 3 is a connecting section 31, and the middle part of the valve stent 2 is provided with a matching connecting interface 221 corresponding to the connecting section 31 of the anchor plate 3. The anchor plate 3 and the connecting interface 221 on the connecting rod in the middle part of the valve stent 2 are connected by mechanical connection methods such as stitching, inlaying, riveting, or sleeve interference gripping, thereby forming a localized barb 4 anchoring structure on the outer surface of the valve stent 2. The barbs 4 of the anchor plate 3 face away from the valve stent 2, and the anchor plate 3 is evenly distributed around the valve stent 2, with a quantity of 2-8. In both compressed and expanded states, it is always parallel to the central axis of the valve stent 2 in the axial direction.

[0047] like Figures 2-4 As shown, the anchoring plate 3 has an overall axisymmetric structure, and the barbs 4 on it are all inclined towards the axis of symmetry of the anchoring plate 3, so that the barbs 4 on both sides of the axis of symmetry are in a facing position (inclined upwards and downwards). Thus, when the anchoring plate 3 recovers from the compressed state (the barbs 4 are parallel to the plate-like structure of the main body), the barbs 4 are actually inserted into the tissue at two opposite angles for anchoring, thus achieving a good anchoring effect regardless of the fluid flow direction. In other embodiments, the barbs 4 may also be arranged in the same direction to jointly resist the displacement of the valve stent to one side.

[0048] Example: Transcatheter valve replacement system

[0049] A transcatheter valve replacement system includes the bulb-expandable prosthetic valve with elastic barbs as described in the above embodiments;

[0050] Also includes:

[0051] Balloon, used to inflate balloon-expandable artificial valve prostheses;

[0052] A compression device is used to compress and load the balloon-expandable artificial valve prosthesis onto the outside of the balloon.

[0053] A delivery device for delivering a balloon loaded with a balloon-expandable artificial valve prosthesis to the target location.

[0054] The balloon is a hollow, cylindrical, air-filled structure made of polymer material. A small tube is connected to the proximal end of the balloon, through which liquid is injected to cause the balloon to expand and inflate, thereby expanding the main support structure compressed on the balloon. Subsequently, when the balloon deflates, it allows the balloon to separate from the valve stent 2.

[0055] The compression device can be an existing device, the purpose of which is to compress and mount the balloon-expandable artificial valve prosthesis outside the balloon; the delivery device can be a delivery catheter, used to guide and deliver the balloon loaded with the balloon-expandable artificial valve prosthesis to the designated target location.

[0056] In use, the artificial valve prosthesis of the present invention is delivered to the designated target via a delivery catheter (device) and then unfolded or released to re-inflate to its full operational size. The designated target is typically located at or near the annulus space where the patient's heart valve will be replaced by the artificial valve prosthesis. Using a delivery catheter allows the bulbo-expandable artificial valve prosthesis to be firmly confined in a compressed state from the outside during delivery, protecting the patient's internal tissues and preventing scratches. It also ensures that the connection structure between the anchor plate 3 and the valve stent 2 remains unaffected during delivery, preventing loosening or relative slippage. This ensures that once the bulbo-expandable artificial valve prosthesis is delivered to the designated location, its structure remains the same as after compression, allowing it to expand and recover according to the predetermined structure and method.

[0057] This method includes two approaches: the transapical approach and the transfemoral artery approach to reach the aortic valve.

[0058] The valve prosthesis is loaded onto the balloon using a gripping device and then entirely loaded into the delivery catheter. The delivery device then repositions the heart valve prosthesis to the target location. Once the valve prosthesis is delivered to the target location along the guidewire, the delivery catheter, which grips the valve stent 2, is slowly withdrawn away from the valve annulus to release the valve stent 2 gripped and loaded onto the balloon. Fluid is injected into the balloon, causing it to gradually inflate and expand the artificial valve 1 and valve stent 2 to the target size. The expanded valve stent 2 is anchored to the target valve annulus and valve annulus location by radial support and the barbs 4 on the outer surface of the anchoring plate 3. After assessing the functionality of the heart valve prosthesis, it is completely released and separated from the delivery device.

[0059] The above embodiment provides an example of an artificial valve used for the aortic valve. In other embodiments, the artificial valve can also be an artificial valve 1 such as a mitral valve, pulmonary valve, or tricuspid valve. In this case, the overall structure and method are the same as or similar to those in the above embodiment.

[0060] In summary, the beneficial effects of this invention are that, through its split structure, the valve stent 2 and the anchor plate 3 can each be made of suitable materials to achieve their respective functions: the hollow mesh structure formed by the valve stent 2 allows it to have a certain degree of compressibility and deformation, enabling it to be compressed to a certain extent and loaded onto the balloon and into the delivery catheter, while its rigidity allows it to form a stable support when deployed, making it less prone to deformation and collapse; the shape memory alloy used in the anchor plate 3 has a certain degree of deformation and recovery ability, and its barbs are elastic, allowing it to be loaded into a small-sized delivery catheter and released and deployed after the delivery catheter is withdrawn, so that the barbs 4 on it are firmly inserted into the tissue after the balloon expands; the anchor plate 3 also forms a reliable mechanical connection with the valve stent 2, thereby effectively realizing the functions of stable support and stable anchoring of the artificial valve prosthesis.

[0061] The above description of the embodiments is provided to enable those skilled in the art to understand and use the invention. It will be apparent to those skilled in the art that various modifications can be made to these embodiments, and the general principles described herein can be applied to other embodiments without inventive effort. Therefore, the present invention is not limited to the above embodiments, and any improvements and modifications made by those skilled in the art based on the disclosure of the present invention without departing from the scope of the invention should be within the protection scope of the present invention.

Claims

1. A bulbous artificial valve prosthesis with elastic barbs, characterized in that, It includes an artificial valve (1), a valve stent (2), and an anchoring plate (3); The artificial valve (1) is disposed inside the valve stent (2), and the anchoring plate (3) is disposed around the outer surface of the valve stent (2); The valve stent (2) has a hollow mesh structure and is compressible; The anchor plate (3) is provided with barbs (4) extending outward; The outer or inner surface of the valve stent (2) is provided with a biocompatible polymer membrane.

2. The bulb-shaped artificial valve prosthesis with elastic barbs according to claim 1, characterized in that, The anchor plate (3) includes a connecting section (31) located in the middle section, and the barbs (4) are distributed on both sides of the connecting section (31).

3. A bulbous artificial valve prosthesis with elastic barbs according to claim 2, characterized in that, The valve stent (2) has a connection interface (221) in the middle that matches the connection section (31). The anchor plate (3) is connected to the valve stent (2) through the cooperation of the connection section (31) and the connection interface (223), and is always parallel to the central axis of the valve stent (2) in the axial direction.

4. A bulbous artificial valve prosthesis with elastic barbs according to claim 2 or 3, characterized in that, The barbs (4) are inclined, and the angle between the barbs (4) and the central axis of the anchor plate (3) is an acute angle.

5. A bulbous artificial valve prosthesis with elastic barbs according to claim 4, characterized in that, The tip of the barb (4) is a double-bevel structure or a single-bevel structure.

6. A bulbous artificial valve prosthesis with elastic barbs according to claim 1, characterized in that, The anchoring plates (3) are configured in multiple ways, and the multiple anchoring plates (3) are evenly distributed on the outer surface of the valve stent (2). The barbs (4) are provided on the side facing away from the valve stent (2).

7. A bulbous artificial valve prosthesis with elastic barbs according to claim 1, characterized in that, The valve stent (2) has a hollow mesh structure in which the units are hexagonal or rhomboid, and multiple unit structures constitute a cylindrical hollow stent structure; the valve stent (2) is made of cobalt chromium alloy or stainless steel.

8. A bulbous artificial valve prosthesis with elastic barbs according to claim 1, characterized in that, The artificial valve (1) is a biological valve or a polymer valve.

9. A transcatheter valve replacement system, characterized in that, Including the ball-expanding artificial valve prosthesis with elastic barbs as described in any one of claims 1-8; Also includes: Balloon, used to inflate balloon-expandable artificial valve prostheses; A compression device is used to compress and load the balloon-expandable artificial valve prosthesis onto the outside of the balloon. A delivery device for delivering a balloon loaded with a balloon-expandable artificial valve prosthesis to the target location.

10. A method of using the transcatheter valve replacement system as described in claim 9, characterized in that, Includes the following steps: The balloon-expandable artificial valve prosthesis is compressed and loaded onto the outside of the balloon using a gripping device, and then placed into the delivery device. After the balloon loaded with the expandable artificial valve prosthesis is guided to the target position along the guide wire in the delivery device, it is withdrawn from the delivery device to allow for the subsequent release of the expandable artificial valve prosthesis; Then, liquid is injected into the balloon to inflate it, and the balloon-expandable artificial valve prosthesis loaded outside the balloon expands to the target size, so that the valve stent (2) forms structural support and the anchor plate (3) forms anchor. The fluid inside the balloon is drained, causing the balloon to contract and separate from the balloon-expandable artificial valve prosthesis, and the balloon and delivery device are completely removed.

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