Artificial heart valve

Abstract

The invention discloses an artificial heart valve which is integrally divided into three sections, namely a valve section, a connecting section and an anchoring section, the top of the valve section and the bottom of the valve section are connected into a whole through the connecting section, so that the whole artificial heart valve is of a cylindrical structure which is integrally connected in a segmented mode. Due to the segmented integrated design, valve function evaluation and displacement risk evaluation can be carried out after the valve segments are completely released, and the valve segments can be completely recycled through a conveying system if the valve segments need to be re-released after evaluation.

Description

Technical Field

[0001] The present invention relates to medical auxiliary equipment, and particularly to an artificial heart valve. Background Art

[0002] Transcatheter aortic valve replacement (TAVR) is a minimally invasive valve replacement technique that delivers an artificial aortic valve to the original aortic valve through interventional catheter technology to replace the diseased valve and achieve the treatment purpose. Transfemoral TAVR is currently widely used in the treatment of severe aortic stenosis, but there are still many challenges in the treatment of isolated aortic valve insufficiency. 1. Difficult valve anchoring: The leaflets and annulus of patients with aortic valve insufficiency are softer, lacking calcification of the leaflets and annulus, making it difficult to provide sufficient frictional force and radial support to anchor the valve. 2. Risk of artificial valve displacement: Due to the lack of sufficient frictional force and radial support, patients with aortic valve insufficiency have a higher risk of valve displacement and embolism. 3. Difficult intraoperative positioning: Patients with aortic valve insufficiency require higher valve coaxiality and implantation depth during the operation, and existing instruments cannot meet the clinical needs. 4. Higher permanent pacemaker implantation rate: To avoid artificial valve displacement, a higher compression ratio and radial support are required when implanting an artificial valve for isolated aortic valve insufficiency, which may cause compression of the conduction bundle and lead to conduction block, increasing the permanent pacemaker implantation rate of patients. 5. During the clinical operation process, the existing artificial valve design may cause immediate or delayed aortic root injury during or after the operation, increasing the surgical risk; 6. Existing self-expanding valves cannot be recovered after complete release, and it is impossible to accurately evaluate the artificial valve release position and displacement risk during TAVR for patients with isolated aortic valve insufficiency. Summary of the Invention

[0003] Aiming at the problems existing in the prior art, the present invention provides an artificial heart valve for transcatheter implantation, which can achieve the following purposes: 1. Provide a shorter valve frame to achieve better coaxiality during the release process, reduce the impact on the coronary artery ostium, and provide an access for subsequent possible coronary artery intervention treatment; 2. The surface of the metal valve frame in contact with the aortic annulus is engraved with patterns / set barbs by laser to increase the frictional force with the aortic annulus and reduce the displacement risk; 3. An anchoring member for anchoring in the ascending aorta increases the contact area between the ascending aorta anchoring area and the blood vessel wall, reduces the potential risk of excessive local pressure on the blood vessel wall in the ascending aorta anchoring area, and at the same time the anchoring member can avoid the risk of artificial valve displacement below the aortic valve; 4. The segmented integral design enables the valve segment to be fully released for valve function evaluation and displacement risk evaluation. If re-release is required after evaluation, it can be completely recovered through the delivery system.

[0004] The technical solution of the present invention is: An artificial heart valve is divided into three segments as a whole, namely a valve segment, a connection segment, and an anchoring segment;

[0005] The top and the bottom of the valve segment are integrally connected by the connecting segment, so that the artificial heart valve as a whole has a cylindrical structure with a segmented and integrated connection.

[0006] Furthermore, a valve is arranged in the inner cylindrical space of the valve segment, and the valve is made of pericardial material.

[0007] Furthermore, a skirt is arranged at the outer bottom of the valve segment, and the material of the skirt is pericardial material, PET material or hydrogel material that expands conformably after absorbing liquid (blood / water), etc., to prevent paravalvular leakage.

[0008] Furthermore, the outer surface of the valve frame of the valve segment is engraved with lines by laser to increase friction.

[0009] Furthermore, barbs are arranged on the outer surface of the valve frame of the valve segment to further reduce the risk of displacement.

[0010] Furthermore, the valve frame of the valve segment has a rhombic grid structure, and the number of rhombic cells at the top layer of the valve frame is less than that of the lower layer, reducing unnecessary rhombic cells at the upper end of the valve segment and improving the blockage of the coronary artery opening.

[0011] Furthermore, three visible marker points are arranged at the bottom edge of the valve frame of the valve segment for aligning with the native valve sinus during the operation.

[0012] Furthermore, the connecting segment is several connecting segment wires respectively connecting the top and the bottom of the valve segment, and the diameter and hardness of the connecting segment wires are less than those of the metal grid of the valve segment, making the connecting segment more compliant and reducing the risk of damage to the aortic vessel wall.

[0013] Furthermore, the surface of the anchoring segment is covered with a film to further reduce the damage of the anchoring segment to the vessel wall, increase the friction between the anchoring segment and the vessel wall, and reduce the risk of displacement.

[0014] Furthermore, the diameter and hardness of the anchoring segment wires of the anchoring segment are less than those of the metal grid of the valve segment. The anchoring segment wires have good compliance and can be applied to ascending aortas of different sizes.

[0015] The beneficial effects of the present invention are as follows: A transcatheter implantable artificial heart valve is provided, which can achieve the following objectives: 1. Provide a shorter valve frame to achieve better coaxiality during the release process, reduce the impact on the coronary ostia, and provide an access for subsequent possible coronary intervention therapy; 2. The surface of the metal valve frame in contact with the aortic valve annulus is engraved with laser patterns / barbs to increase the friction with the aortic valve annulus and reduce the risk of displacement; 3. An anchor for anchoring to the ascending aorta is provided to increase the contact area between the ascending aorta anchoring region and the vessel wall, reduce the potential risk of excessive local pressure on the vessel wall in the ascending aorta anchoring region, and at the same time, the anchor can avoid the risk of the artificial valve displacing below the aortic valve; 4. The segmented integrated design enables the valve segment to be fully released for valve function assessment and displacement risk assessment. If re-release is required after assessment, it can be fully recovered through the delivery system. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 It is a schematic diagram of the overall structure of the artificial heart valve;

[0017] Figure 2 It is a schematic diagram of the surface film covering of the anchoring segment;

[0018] Figure 3 It is a schematic diagram after the artificial heart valve is implanted.

[0019] In the figure: 1 is the valve segment, 2 is the connecting segment, and 3 is the anchoring segment. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0020] The present invention will be further described below with reference to the accompanying drawings.

[0021] The present invention provides a transcatheter implantable artificial valve as Figure 1 shown, which is a cylindrical structure with a segmented integrated connection, including a valve segment 1 and an anchoring segment 3 connected to the valve segment 1. The valve segment 1 and the anchoring segment 3 are connected by an elastic connecting segment 2.

[0022] The valve segment has the following characteristics:

[0023] 1. A valve is arranged in the internal cylindrical space, and the valve is made of pericardial material.

[0024] 2. A skirt is arranged at the outer bottom, and the optional materials include pericardium or PET, hydrogel materials that absorb blood / water and expand compliantly, etc., to prevent paravalvular leakage.

[0025] 3. The outer side of the valve frame of the valve segment is engraved with laser textures to increase friction. Optionally, barbs can be provided to further reduce the risk of displacement.

[0026] 4. Unnecessary diamond grids at the upper end of the valve segment are reduced to improve the blockage of the coronary ostia.

[0027] 5. Three radiopaque marker points are provided at the bottom edge of the valve frame for alignment with the native valve sinuses during the operation.

[0028] The connecting section has the following characteristics:

[0029] 1. The diameter and hardness of the wire are smaller than those of the valve section, making the connecting section more compliant and reducing the risk of damage to the aortic vessel wall.

[0030] The structural schematic of the anchoring section is as Figure 2 shown:

[0031] 1. The wire of the anchoring section has good compliance and can be applied to ascending aortas of different sizes.

[0032] 2. The surface of the anchoring section can be covered with a film to further reduce the damage of the anchoring section to the vessel wall, increase the friction between the anchoring section and the vessel wall, and reduce the risk of displacement.

[0033] As Figure 3 shown, the valve section is anchored by the radial support force and the friction between the valve frame and the aortic root tissue. An artificial aortic valve is arranged in the internal channel of the valve section, which can replace the original diseased valve to play a role.

[0034] The anchoring section is a structure composed of a wire and a film, which can be compressed compliantly to adapt to ascending aortas of different sizes and structures. The anchoring section is connected to the valve section through the connecting section, so that the valve section can still be retrieved through the delivery system when it is in a fully released state, which is convenient for the operator to accurately evaluate the valve position, displacement risk, etc. during the operation.

[0035] In summary, the present embodiment provides a transcatheter implantable artificial heart valve, which can achieve the following purposes: 1. Provide a shorter valve frame to achieve better coaxiality during the release process, reduce the impact on the coronary ostia, and provide an access for subsequent possible coronary intervention; 2. The surface of the metal valve frame in contact with the aortic valve annulus is laser engraved with patterns / set with barbs to increase the friction with the aortic valve annulus and reduce the risk of displacement; 3. The anchoring member for anchoring to the ascending aorta increases the contact area between the ascending aorta anchoring region and the vessel wall, reduces the potential excessive local pressure of the ascending aorta anchoring region on the vessel wall and causes potential vessel injury risk, and at the same time the anchoring member can avoid the risk of the artificial valve displacing below the aortic valve; 4. The segmented integral design enables the valve function evaluation and displacement risk evaluation to be carried out after the valve section is fully released. If re-release is required after the evaluation, it can be fully retrieved through the delivery system.

[0036] The above are only the preferred embodiments of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle of the present invention, several improvements and refinements can be made, and these improvements and refinements should also be regarded as the protection scope of the present invention.

Claims

1. An artificial heart valve, characterized in that: The whole is divided into three sections, namely the valve section (1), the connecting section (2) and the anchoring section (3); The top of the valve section (1) and the bottom of the valve section (3) are connected as a whole through the connecting section (2), so that the artificial heart valve as a whole is a segmented and integrally connected cylindrical structure.

2. The artificial heart valve according to claim 1, wherein: A valve is arranged in the inner cylindrical space of the valve section (1), and the valve is made of pericardial material.

3. The artificial heart valve according to claim 1, characterized in that: A skirt is arranged at the outer bottom of the valve section (1), and the material of the skirt is pericardial material, PET material or a hydrogel material that expands conformably after absorbing liquid.

4. An artificial heart valve according to claim 1, characterized in that: The outer surface of the valve frame of the valve section (1) is engraved with patterns by laser.

5. An artificial heart valve according to claim 1, characterized in that: Barbs are arranged on the outer surface of the valve frame of the valve section (1).

6. The artificial heart valve according to claim 1, wherein: The valve frame of the valve section (1) has a diamond grid structure, and the number of diamond cells in the top layer of the valve frame is less than that in the lower layer.

7. An artificial heart valve according to claim 1, characterized in that: Three visible marking points are arranged at the bottom edge of the valve frame of the valve section (1) for aligning with the native valve sinus during the operation.

8. An artificial heart valve according to claim 1, characterized in that: The connecting section (2) is several connecting section metal wires respectively connecting the top of the valve section (1) and the bottom of the valve section (3), and the diameter and hardness of the connecting section metal wires are smaller than those of the metal grid of the valve section.

9. The artificial heart valve according to claim 1, wherein: The surface of the anchoring section (3) is covered with a film.

10. An artificial heart valve according to claim 1, characterized in that: The diameter and hardness of the anchoring section metal wires of the anchoring section (3) are smaller than those of the metal grid of the valve section.

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