Heart valve positioning device

Abstract

The present invention discloses a heart valve positioning device, including anchoring units, the number of which is not less than the number of valves at the target installation position; a plurality of anchoring units are distributed along the circumference, and are connected to each other through an axially extending connecting portion to form a closed hollow thin-walled structure; each anchoring unit includes an upper component and a lower component, the two ends of the upper component and the lower component are respectively fixedly connected to the connecting portion, and the two connecting points on the same side of the connecting portion are spaced apart from each other; the upper component and the lower component are spaced apart along the axial direction of the hollow thin-walled structure, and there is at least one first spacing between the upper component and the lower component, and the first spacing is used to clamp the native heart valve. Controlling the spacing of the gap between the upper component and the lower component can adjust the clamping force of the native valve between the upper component and the lower component; simplifying the clamping method of the native leaflet, reducing the design complexity and processing difficulty.

Description

Technical Field

[0001] The invention relates to medical equipment, in particular to a heart valve positioning device, and belongs to the technical field of medical equipment. Background Art

[0002] Aortic valve stenosis and aortic valve regurgitation are common clinical degenerative diseases of the human aortic valve. In the existing treatment scheme, the artificial device relies on radial support force to abut against the calcified part of the human aortic valve, and then anchors at the native valve leaflet, replacing the native valve to work and restore normal blood flow at the aortic valve. However, the anchoring strength of the existing artificial valve is difficult to meet expectations, especially for mild calcified aortic valve stenosis and simple aortic valve regurgitation. There are fewer or no calcified parts at the aortic valve, and the leaflets are relatively soft, which cannot provide sufficient support for the artificial aortic valve. In addition, for aortic valves with simple regurgitation, it is often accompanied by valve ring expansion. After the artificial aortic valve is implanted, it cannot be firmly anchored at the native valve leaflet and is prone to falling off. The above problems are often encountered in mitral or tricuspid valve regurgitation.

[0003] Since human tissue cannot provide sufficient support for artificial heart valves and cannot fix artificial heart valves at target positions, a new medical device is needed to solve at least one of the above problems of implantation and anchoring of artificial heart valves. Summary of the invention

[0004] In order to overcome the problem that artificial heart valves in the prior art cannot be stably anchored, the present invention proposes an artificial heart valve positioning device, which can be stably anchored in the human body, thereby providing stable anchoring support for the artificial heart valve or valve stent. The positioning device provided by the present invention can adjust the clamping force of the native valve between the upper component and the lower component by at least controlling the spacing of the gap between the upper component and the lower component.

[0005] To achieve the above-mentioned purpose, according to one aspect of an embodiment of the present invention, a heart valve positioning device is provided, comprising: anchoring units, the number of which is not less than the number of valves at the target installation position; a plurality of the anchoring units are distributed along the circumference, and are connected to each other by an axially extending connecting portion to form a closed hollow thin-walled structure; each of the anchoring units comprises an upper component and a lower component, the two ends of the upper component and the lower component are respectively fixedly connected to the connecting portion, and the two connection points on the same side of the connecting portion are spaced apart from each other; the upper component and the lower component are spaced apart along the axial direction of the hollow thin-walled structure, and there is at least one first spacing between the upper component and the lower component, and the first spacing is used to clamp the native heart valve.

[0006] Optionally, a first connection unit is provided at the bottom of the lower member, and the first connection unit is connected to a first component of the conveying system to adjust the shape of the lower member through the first component; and / or

[0007] A second connection unit is provided on the end of the connection portion away from the first connection unit. The second connection unit is connected to a second component of the conveying system, and the shape of the upper component is adjusted through the second component.

[0008] Optionally, in the positioned state, the native heart valve is disposed between the upper component and the lower component, and the native heart valve maintains normal blood flow.

[0009] Optionally, in the positioning state, the outer peripheral wall of the heart valve positioning device rests against the inner wall of the aorta.

[0010] Optionally, at least one artificial heart valve clamp is further provided above and / or below each of the upper components and / or lower components, and the plane where the artificial heart valve clamp is located is not perpendicular to the axis of the positioning device.

[0011] Optionally, the portion of the artificial heart valve clamp close to the axis of the positioning device is a protrusion, and the diameter of a circle that is simultaneously tangent to the protrusions of multiple artificial heart valve clamps is smaller than the outer diameter of the artificial heart valve, so that the artificial heart valve clamp can be pushed to expand outward and clamp the artificial heart valve during the assembly process of the artificial heart valve.

[0012] Optionally, a clamping unit is provided in the middle of the connecting portion, and at least one protrusion protruding toward an adjacent upper component is provided on both sides of the clamping unit, and there is at least one second distance between the protrusion and the adjacent upper component, and the second distance is used to clamp the native heart valve.

[0013] Optionally, a plurality of support rods are arranged above each of the upper components, and the plurality of support rods form a mesh structure.

[0014] Optionally, the upper component is a W-shaped, M-shaped or V-shaped structure, and there is at least one first distance between the upper component and the lower component, and the first distance is used to clamp the native heart valve.

[0015] Optionally, the upper component is a wavy structure, the number of bending segments of the wavy structure is greater than 2, and there is at least one first distance between the upper component and the lower component, and the first distance is used to clamp the native heart valve.

[0016] Optionally, the lower component is a W-shaped, M-shaped or V-shaped structure, and there is at least one first distance between the upper component and the lower component, and the first distance is used to clamp the native heart valve.

[0017] Optionally, the lower component is a wavy structure, the number of bending segments of the wavy structure is greater than 2, and there is at least one first distance between the upper component and the lower component, and the first distance is used to clamp the native heart valve.

[0018] Optionally, a clamping unit is provided in the middle of the connecting portion, and protrusions protruding toward adjacent upper components are respectively provided on both sides of the clamping unit, and there is at least one second distance between the protrusion and the adjacent upper component, and the second distance is used to clamp the native heart valve.

[0019] Optionally, a side of the connecting portion away from the lower component is inclined toward a central axis of the positioning device.

[0020] The technical solution of the present invention has the following advantages or beneficial effects:

[0021] (1) After the upper member and the lower member of the present invention are connected to the connecting portion, two connecting points on the same side of the connecting portion are spaced apart from each other to ensure that the positioning device has sufficient structural strength.

[0022] (2) The upper member and the lower member are spaced apart along the axial direction of the hollow thin-walled structure, and there is at least one first spacing between the upper member and the lower member, and the first spacing is used to clamp the native heart valve. The clamping force of the native valve between the upper member and the lower member can be adjusted by controlling the spacing of the gap between the upper member and the lower member. This arrangement simplifies the clamping method of the native valve leaflet, ensures the anchoring strength of the positioning device, and ensures the connection reliability of the subsequent artificial heart valve implantation. Furthermore, the positioning device of the present invention has a certain compressibility in the radial direction, can be folded in the transportation system, and unfolded after reaching the target position. The positioning device of the present invention can be transported separately and fixed at the valve leaflet, and then the artificial heart valve is transported into place. Compared with the scheme of transporting an artificial heart valve with a positioning member in the prior art, it can significantly reduce the inner diameter of the delivery system and reduce the risk of vascular complications.

[0023] (3) After the positioning device of the present invention is implanted, the upper component and the lower component are not clamped on the side of the free edge of the native valve leaflet, which will not completely restrict the movement of the native valve leaflet and can also ensure normal blood circulation.

[0024] (4) By setting the position of the artificial heart valve clamp and its protrusion, the artificial heart valve clamp has a certain inclination angle, so as to facilitate the delivery of the artificial heart valve into the interior of the positioning device. While the inner wall of the anchoring unit is pressed against the outer wall of the artificial heart valve, the protrusion of the artificial heart valve clamp can be used to further push the outer wall of the artificial heart valve, and the artificial heart valve is firmly clamped by multiple thrusts, thereby improving the anchoring strength of the artificial heart valve. The setting method in which the protrusion is tangent to the same circumscribed circle can make the same external force be applied to the artificial heart valve clamp in all directions during the implantation of the artificial heart valve, thereby improving the stability of the anchoring of the positioning device and avoiding the displacement of the positioning device due to uneven force on the artificial heart valve clamp. The above setting method also reduces the difficulty of processing and assembling the artificial heart valve clamp.

[0025] (5) By setting the clamping unit, at least one second clamping site is generated between the protrusion on the clamping unit and the upper member on the side of the leaflet. The clamping method of each anchoring unit will generate at least one clamping site on the upper side, left side and right side of the native leaflet, thereby clamping the native leaflet at multiple positions, making it difficult for the positioning device to fall off when the native heart valve opens and closes, thereby improving the clamping force of the positioning device and enabling it to be stably installed on the aorta.

[0026] (6) Multiple struts are connected to form multiple mesh structures, which increase the contact area between the positioning device and the artificial aortic valve stent, thereby enhancing the anchoring force of the positioning device on the artificial heart valve. At the same time, the outer wall of the mesh structure can also increase its contact area with the inner wall of the aorta, thereby improving the anchoring strength of the positioning device.

[0027] (7) The positioning device of the present invention can also be used as an aortic valve repair device. One of the causes of aortic valve regurgitation is the expansion of the aortic valve ring, which prevents the valve leaflets from completely aligning. After the positioning device of the present invention is implanted, the free ends of some native valve leaflets can be clamped between the side of the upper component and the connecting part to achieve the effect of reducing the aortic valve ring, thereby reducing the aortic valve regurgitation. In order to achieve a better effect, the connecting part can be tilted at a certain angle to the central axis of the positioning device to further reduce the valve orifice area and improve aortic regurgitation. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 A schematic diagram of an artificial heart valve positioning device according to an embodiment of the present invention;

[0029] Figure 2 A schematic diagram of an artificial heart valve positioning device in an implanted state according to an embodiment of the present invention;

[0030] Figure 3 A schematic diagram of an artificial heart valve positioning device according to an embodiment of the present invention in another perspective of an implanted state;

[0031] Figure 4 A schematic diagram of a positioning device with an artificial heart valve clamp according to an embodiment of the present invention;

[0032] Figure 5 A schematic top view of a positioning device with an artificial heart valve clamp according to an embodiment of the present invention;

[0033] Figure 6 A schematic diagram of assembling a positioning device with an artificial heart valve clamp and an artificial valve stent according to an embodiment of the present invention;

[0034] Figure 7 is a schematic diagram of a positioning device with a clamping unit according to an embodiment of the present invention;

[0035] Figure 8 A schematic diagram of a positioning device having a mesh structure on an upper member according to an embodiment of the present invention;

[0036] Fig. 9 A schematic diagram of a positioning device in which the upper member is W-shaped according to an embodiment of the present invention;

[0037] Fig.10 A schematic diagram of a positioning device in which the upper member is wavy in shape according to an embodiment of the present invention;

[0038] Fig.11 A schematic diagram of a positioning device in which a lower member is wavy and has a clamping unit according to an embodiment of the present invention;

[0039] Figure 12-13 This is a schematic diagram of a positioning device with a curved connecting portion according to an embodiment of the present invention. DETAILED DESCRIPTION

[0040] The following is a description of exemplary embodiments of the present invention in conjunction with the accompanying drawings, including various details of the embodiments of the present invention to facilitate understanding, which should be considered as merely exemplary. Therefore, it should be recognized by those of ordinary skill in the art that various changes and modifications may be made to the embodiments described herein without departing from the scope and spirit of the present invention. Similarly, for clarity and conciseness, the description of well-known functions and structures is omitted in the following description.

[0041] In order to solve at least one problem in the background technology, one aspect of the present invention provides a heart valve positioning device. In practice, the existing artificial heart valve is directly connected to the inner wall of the aorta. The anchoring strength of this connection method is difficult to achieve the expected, which is easy to cause intraoperative or postoperative risks. Especially in the case of mild calcified aortic valve stenosis and simple aortic valve regurgitation, there are fewer or no calcified parts at the aortic valve, and the valve leaflets are relatively soft, which cannot provide sufficient support for the artificial aortic valve, resulting in the anchoring effect cannot meet the surgical requirements. In addition, for the aortic valve with simple regurgitation, it is often accompanied by valve ring expansion. After the artificial aortic valve is implanted, it cannot be firmly anchored at the native valve leaflet and is prone to fall off. Therefore, the present invention provides a heart valve positioning device, which can be stably anchored on human tissue, thereby providing stable support for the artificial heart valve, improving or enhancing the connection stability of the artificial heart valve after implantation in the human body, and overcoming the problem that the implantation scheme of the prior art cannot stably anchor the artificial heart valve.

[0042] An artificial heart valve positioning device provided in one aspect of the present invention includes anchoring units, the number of which is not less than the number of valves (or leaflets) at the target installation position; a plurality of the anchoring units are distributed along the circumference, and are connected to each other by axially extending connecting parts to form a closed hollow thin-walled structure. One embodiment of the present invention fixes the positioning device by providing a plurality of anchoring units to clamp the native leaflets. In practice, since the number of leaflets at different tissue locations is different, it is necessary to match the number of anchoring units with the number of native valves to provide a stable anchoring force. Of course, the "quantity matching" can be adjusted according to the actual needs of use. For example, the number of anchoring units can be set to be less than or equal to the number of native valves at the target tissue. Figure 1 In the illustrated embodiment, the artificial heart valve positioning device 1 is provided with three anchoring units 11, corresponding to three valves respectively. The plurality of anchoring units 11 are distributed along the circumference, and are connected to each other through axially extending connecting parts 12 to form a closed hollow thin-walled structure. The purpose of adopting the circumferential distribution in this embodiment is to match the geometric shape of the human aorta. In an optional embodiment, the positioning device can be installed in the target position and fit well with the aorta by adjusting the diameter of the device. The closed structure described here refers to the anchoring units and the connecting parts being connected sequentially in the circumferential direction, thereby forming a closed annular structure in the circumferential direction. In an optional embodiment, the positioning device is made into a hollow structure, which can reduce the diameter of the positioning device after being gripped, so that it can be delivered using a delivery system with a smaller inner diameter, and is conducive to the stent passing through the arch. Figure 1 As shown, if the same size of materials are selected to make the positioning device 1, then after the hollow thin-walled structure is formed, it can be ensured that the outer diameters of the various components of the hollow thin-walled structure are the same, and the inner diameters of the various components are also the same. Figure 1 In the illustrated embodiment, each anchoring unit 11 includes an upper member 1101 and a lower member 1102, and the upper member and the lower member can be arranged up and down on the same circular curved surface, so that the distance from the outer wall of the upper member and the lower member to the axis of the positioning device is equal. Optionally, the upper member and the lower member can adopt a simple structure such as a U-shape or a V-shape to achieve a better fit with the bottom of the aortic sinus, and the arc-shaped structure of the bottom can avoid causing damage to the valve leaflets. Further, the two ends of the upper member and the lower member are respectively fixedly connected to the connecting portion 12, and the connection method can be achieved by welding, riveting and other common connection methods, and the specific connection methods are not described one by one here. For example, the positioning device can be formed by bending and welding nickel-titanium wire or other plastically deformable wire. Optionally, the cross section of the wire can be circular or square, etc. Of course, it can also be connected and formed by mechanical riveting using a sheet. In an optional embodiment, the positioning device can also be made by laser cutting, for example, using nickel-titanium tubes or other plastically deformable tubes to form an entirety by laser cutting. In addition, in an optional embodiment, in order to facilitate connection, the ends of the upper member and the lower member can be appropriately bent, that is, connecting ends are made on the upper member and the lower member, and then the connecting ends are fixed to the connecting portion 12. In one embodiment, the positioning device has a certain axial length to match the installation with the artificial heart valve, so that after the upper member and the lower member are connected to the connecting portion, the two connection points on the same side of the connecting portion are spaced apart from each other. Advantageously, this distribution method can also ensure that the positioning device has sufficient structural strength. It can be understood that the connecting end of the upper member can be connected to the upper part of the connecting portion, and the connecting end of the lower member can be connected to the lower part of the connecting portion, so that the two connection points on the left side or the right side are spaced apart. In some embodiments, after the two ends of the anchoring unit 11 are connected to the adjacent connecting portions 12, the peaks of the upper member and the lower member are formed, and the top of the connecting portion 12 is higher than the peak of the upper member. Figure 1 In the illustrated embodiment, the upper component and the lower component are spaced apart along the axial direction of the hollow thin-walled structure, and there is at least one first spacing between the upper component and the lower component, and the first spacing is used to clamp the native heart valve. In actual use, the clamping force of the native valve between the upper component and the lower component can be adjusted by controlling the spacing of the gap between the upper component and the lower component. The positioning device in this embodiment can be formed into a thin-walled hollow structure through a variety of processing methods, and can be delivered and fixed at the leaflet alone, and then the artificial heart valve can be delivered into place, which can reduce the inner diameter of the delivery system and reduce the risk of vascular complications. The specific retraction and expansion process is described in detail below. Figure 2 and 3, which shows a schematic diagram of an artificial heart valve positioning device according to an embodiment of the present invention after being assembled to the aortic root. The native valve leaflet 201 is clamped between the upper member and the lower member, and the valve leaflet attachment edge 202 also passes through the gap between the upper member and the lower member. Optionally, the first spacing between the upper member and the lower member (such as Figure 1 The minimum spacing between the upper component and the lower component at the bottom end is no more than 1 mm, that is, the bottom end distance needs to be no greater than the thickness of the native leaflet, so that the native leaflet is clamped between the upper component and the lower component with an interference fit, thereby realizing stable anchoring of the positioning device shown in an embodiment of the present invention.

[0043] Optionally, a first connection unit is provided at the bottom of the lower component, and the first connection unit is connected to a first component of the conveying system so as to adjust the shape of the lower component through the first component. A second connection unit is provided on the end of the connecting portion away from the first connection unit, and the second connection unit is connected to a second component of the conveying system, and the shape of the upper component is adjusted through the second component. Since the positioning device structure provided in the first aspect of the present invention is a newly designed one, it is necessary to redesign the matching conveying system in order to control the action of the anchoring unit in the positioning device, so as to effectively clamp the native leaflet. Specifically, it is necessary to control the shapes of the upper component and the lower component in the anchoring unit so as to clamp the native leaflet between the two. Figure 1 In the illustrated embodiment, a first connection unit 111 is provided at the bottom of the lower member, and a second connection unit 121 is provided at the end of the connection portion away from the first connection unit. The second connection unit 121 can usually be provided at the top of the connection portion 12. In practice, the first connection unit 111 is connected to the first component of the conveying system to adjust the shape of the lower member through the first component; the second connection unit 121 is connected to the second component of the conveying system, and the shape of the upper member is adjusted through the second component. The timing of the shape change of the upper and lower members is controlled by reasonably manipulating the order of the various elements of the conveying system, so that the native leaflet is clamped between the upper and lower members. The specific operation process is described below.

[0044] Optionally, in the positioning state, the peripheral wall of the heart valve positioning device can be against the inner wall of the aorta or there is a gap with the inner wall of the aorta, and / or the native heart valve is inserted between the upper component and the lower component, and the native heart valve maintains normal blood flow. After installation, the lower component in one embodiment of the present invention will be close to the attachment edge of the valve leaflet on the atrial wall or the aortic wall, so it will not completely restrict the movement of the native valve. After the positioning device is implanted, the native valve will maintain normal blood flow. Due to the normal blood flow, the safety of the operation is ensured, the difficulty of the operation is reduced, and the probability of successful operation is increased.

[0045] Optionally, an artificial heart valve clamp is further provided above and / or below each of the upper and / or lower components, and the plane where the artificial heart valve clamp is located is not perpendicular to the axis of the positioning device. Figure 4 In the embodiment shown, in order to improve the clamping force of the artificial heart valve and improve its connection strength, in one embodiment of the present invention, at least one artificial heart valve clamp 112 is further arranged above each of the upper components. In an optional embodiment, the sizes of the anchoring units are the same, and the positioning device is arranged in a symmetrical structure. Furthermore, the artificial heart valve clamp can also be bent into a symmetrical structure, which can be specifically as follows: Figure 4 The bending shape shown in the figure has an axis of symmetry 502. The axis of symmetry is not arranged perpendicularly to the axis 501 of the positioning device, and there is an angle θ between the two. The protrusion of the artificial heart valve clamp close to the axis of the positioning device is inclined toward the lower component. The purpose of this setting is to make the protrusion close to the axis 501 and make the angle θ an acute angle. In an optional embodiment, the angle θ is set to 60°. It should be noted that the purpose of setting the position of the artificial heart valve clamp and its protrusion in this embodiment of the present invention is to make the artificial heart valve clamp have a certain inclination angle, so as to facilitate the delivery of the artificial heart valve into the interior of the positioning device. While the inner wall of the anchoring unit is used to press against the outer wall of the artificial heart valve, the protrusion of the artificial heart valve clamp can be used to further push against the outer wall of the artificial heart valve, and the artificial heart valve is firmly clamped by multiple thrust forces, thereby improving the anchoring strength of the artificial heart valve. This embodiment is only an example. It is understood that the artificial heart valve clamping member can be arranged on the upper member and / or the lower member, and its arrangement position on the upper member or the lower member can also be appropriately adjusted as needed, such as being arranged above or below. In addition, the number of artificial heart valve clamping members can also be adjusted according to usage requirements.

[0046] Optionally, the portion of the artificial heart valve clamping member close to the axis of the positioning device is a raised portion, and the diameter of the circle that is simultaneously tangent to the raised portions of the plurality of artificial heart valve clamping members is smaller than the outer diameter of the artificial heart valve, so that the artificial heart valve clamping member is pushed to expand outward and clamp the artificial heart valve during the assembly process. Figure 5 As shown, the positioning device shown in this embodiment is Figure 4 The spatial distribution of the protrusions is further defined on the basis of the embodiment shown. Figure 5In the top view shown, the raised portions 503 at the symmetrical parts of the artificial heart valve clamp are tangent to the common circumscribed circle 504. This arrangement enables the same external force to be applied to the artificial heart valve clamp in all directions during the implantation of the artificial heart valve, thereby improving the stability of the anchoring of the positioning device and preventing the positioning device from being offset due to uneven force on the artificial heart valve clamp. Furthermore, the diameter of the tangent circle 504 is smaller than the outer diameter of the artificial heart valve, thereby pushing the artificial heart valve clamp to expand outward and clamp the artificial heart valve during the assembly of the artificial heart valve. The purpose of this arrangement is to clamp the artificial heart valve through an interference fit and improve its anchoring stability. Therefore, the setting of the interference amount is the key to the setting here. In practice, different interference amounts can be set according to the different materials used to make the positioning device to obtain the required artificial heart valve anchoring strength. Figure 6 In one embodiment, the artificial heart valve stent 15 is clamped by an artificial heart valve clamp.

[0047] Optionally, a clamping unit is provided in the middle of the connecting portion, and at least one protrusion protruding toward the adjacent upper member is provided on both sides of the clamping unit, and at least one second spacing is provided between the protrusion and the adjacent upper member, and the second spacing is used to clamp the native heart valve. Figure 7 As shown, in order to further increase the clamping force on the leaflets and improve the anchoring stability of the positioning device, the present invention further provides an embodiment in which the number of anchoring points on the leaflets is increased. Specifically, a clamping unit 13 may be provided in the middle of the connecting portion 12. The shape of the clamping unit 13 is not limited to Figure 7 The petal-shaped structure shown. At least one protrusion protruding toward the adjacent upper member is respectively provided on both sides of the clamping unit 13. Optionally, the protrusion preferably extends circumferentially along the cylindrical surface where the thin-walled member described above is located. There is at least one second spacing between the protrusion and the adjacent upper member, and the second spacing is used to clamp the native heart valve. In practice, the upper member and the lower member produce at least one first clamping site for the native leaflet between the bottoms of the two; and when the clamping unit 13 is set, at least one second clamping site is produced between the protrusion thereon and the upper member on the side of the leaflet. When each anchoring unit is observed separately, it can be found that the above-mentioned clamping method will produce at least one clamping site on the upper side, left side and right side of the native leaflet, respectively, so that the native leaflet is clamped at multiple positions, so that the positioning device is not easy to fall off when the native heart valve opens and closes, and the clamping force of the positioning device is improved, so that it can be stably installed in the human body.

[0048] Optionally, a plurality of supporting rods are arranged above each of the upper components, and the plurality of supporting rods form a mesh structure. Figure 8In the illustrated embodiment, a plurality of struts 14 may be distributed on the upper component of the heart valve positioning device, and the plurality of struts are interconnected to form a plurality of mesh structures, which increase the contact area between the positioning device and the artificial aortic valve stent, thereby achieving the effect of enhancing the anchoring force of the positioning device on the artificial heart valve. At the same time, the outer wall of the mesh structure may also increase its contact area with the inner wall of the aorta, thereby improving the anchoring strength of the positioning device. Preferably, the mesh structure may be composed of shapes such as rhombus and square, so that the mesh structure can be folded or unfolded in the transport system, thereby improving the convenience of the device implantation operation.

[0049] Optionally, the upper member is a W-shaped, M-shaped or V-shaped structure, and there is at least one first distance between the upper member and the lower member, and the first distance is used to clamp the native heart valve. Fig. 9 In the illustrated embodiment, the upper member is formed into a W-shaped, M-shaped or V-shaped structure by bending the rod. This shape does not increase the manufacturing difficulty, but can form at least one first distance between the upper member and the lower member. Compared with the upper member of the U-shaped structure described above, it can further improve the clamping effect of the native leaflets between the anchoring units.

[0050] Optionally, the upper member is a wave-shaped structure, the number of bending segments of the wave-shaped structure is greater than 2, and there is at least one first spacing between the upper member and the lower member, and the first spacing is used to clamp the native heart valve. Fig.10 As shown, the upper member can be further configured to be wavy, and the wavy here is different from the W-shape, M-shape or V-shape described above, and the number of bends is greater than the number of bends of the W-shape, M-shape or V-shape, that is, the number of bends of the wavy structure is greater than 2. Due to the increase in the number of bends, those skilled in the art can understand that the number of first spacings between the upper member and the lower member can be reasonably set according to the need for clamping force, so as to clamp the native heart valve through more first spacings.

[0051] Optionally, the lower component is a W-shaped, M-shaped or V-shaped structure, and there is at least one first distance between the upper component and the lower component, and the first distance is used to clamp the native heart valve.

[0052] Optionally, the lower component is a wavy structure, the number of bending segments of the wavy structure is greater than 2, and there is at least one first distance between the upper component and the lower component, and the first distance is used to clamp the native heart valve.

[0053] Optional, such as Fig.11In the shown embodiment, on the basis of the lower component with a wavy structure, a clamping unit can be further provided in the middle of the connecting portion, and protrusions protruding toward the adjacent upper component are respectively provided on both sides of the clamping unit, and there is at least one second distance between the protrusion and the adjacent upper component, and the second distance is used to clamp the native heart valve.

[0054] It should be noted that the upper member and the lower member can be provided with a wavy structure, an M-shaped structure, a W-shaped structure or a V-shaped structure at the same time or only on one of them, or the upper member and the lower member can be provided with a mesh structure at the same time or only on one of them; or a clamping unit is provided on the connecting portion. In other words, the above-mentioned structure can be varied, and those skilled in the art can combine various clamping features in various ways based on the above-mentioned embodiments shown in the present invention as needed, but such combinations are still within the protection scope of this case.

[0055] Optional, such as Figure 12-13 As shown, the side of the connection portion away from the lower component is inclined toward the central axis of the positioning device. In actual use, the positioning device of the present invention can also be used as an aortic valve repair device. One of the reasons for aortic valve regurgitation is the expansion of the aortic valve ring, and the leaflets cannot be completely aligned. After the positioning device of the present invention is implanted, part of the native leaflet free ends can be clamped between the side of the upper component and the connection portion to achieve the effect of reducing the aortic valve ring, thereby reducing the regurgitation of the aortic valve. In order to achieve better results, the connection portion can be tilted at a certain angle to the central axis of the positioning device to reduce the valve area to a greater extent and improve aortic regurgitation.

[0056] The above specific implementations do not constitute a limitation on the protection scope of the present invention. It should be understood by those skilled in the art that various modifications, combinations, sub-combinations and substitutions may occur depending on design requirements and other factors. Any modification, equivalent substitution and improvement made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A heart valve positioning device, include: Anchoring units, the number of which is not less than the number of valves at the target installation position; The plurality of anchoring units are distributed along the circumference and connected to each other via axially extending connecting parts to form a closed hollow thin-walled structure; Features: Each of the anchoring units comprises an upper member and a lower member, both ends of the upper member and the lower member are respectively fixedly connected to the connecting portion, and two connecting points on the same side of the connecting portion are spaced apart from each other; The upper component and the lower component are spaced apart along the axial direction of the hollow thin-walled structure, and there is at least one first spacing between the upper component and the lower component, and the first spacing is used to clamp the native heart valve; A first connection unit is provided at the bottom of the lower member, and the first connection unit is connected to a first component of the conveying system so as to adjust the shape of the lower member through the first component; and / or a second connection unit is provided at an end of the connecting portion away from the first connection unit, and the second connection unit is connected to a second component of the conveying system, and the shape of the upper member is adjusted through the second component; The clamping force of the native valve between the upper component and the lower component can be adjusted by controlling the first distance between the upper component and the lower component.

2. The heart valve positioning device according to claim 1, It is characterized in that In the positioned state, the native heart valve is disposed between the upper component and the lower component, and the native heart valve maintains normal blood flow.

3. The heart valve positioning device according to claim 2, It is characterized in that In the positioning state, the outer peripheral wall of the heart valve positioning device abuts against the inner wall of the aorta.

4. The heart valve positioning device according to claim 1 or 2, It is characterized in that At least one artificial heart valve clamp is also arranged above and / or below each of the upper components and / or lower components, and the plane where the artificial heart valve clamp is located is not perpendicular to the axis of the positioning device.

5. The heart valve positioning device according to claim 4, It is characterized in that The portion of the artificial heart valve clamping member close to the axis of the positioning device is a protrusion, and the diameter of a circle that is simultaneously tangent to the protrusions of the plurality of artificial heart valve clamping members is smaller than the outer diameter of the artificial heart valve, so that the artificial heart valve clamping member can be pushed to expand outward and clamp the artificial heart valve during the assembly process of the artificial heart valve.

6. The heart valve positioning device according to claim 1 or 2, It is characterized in that A clamping unit is arranged in the middle of the connecting part, and at least one protrusion protruding toward the adjacent upper component is arranged on both sides of the clamping unit. There is at least one second distance between the protrusion and the adjacent upper component, and the second distance is used to clamp the native heart valve.

7. The heart valve positioning device according to claim 1 or 2, It is characterized in that A plurality of supporting rods are arranged above each of the upper components, and the plurality of supporting rods form a mesh structure.

8. The heart valve positioning device according to claim 1 or 2, It is characterized in that The upper component is a W-shaped, M-shaped or V-shaped structure, and there is at least one first distance between the upper component and the lower component, and the first distance is used to clamp the native heart valve.

9. The heart valve positioning device according to claim 1 or 2, It is characterized in that The upper component is a wave-shaped structure, the number of bending sections of the wave-shaped structure is greater than 2, and there is at least one first distance between the upper component and the lower component, and the first distance is used to clamp the native heart valve.

10. The heart valve positioning device according to claim 1 or 2, It is characterized in that The lower component is a W-shaped, M-shaped or V-shaped structure, and there is at least one first distance between the upper component and the lower component, and the first distance is used to clamp the native heart valve.

11. The heart valve positioning device according to claim 1 or 2, It is characterized in that The lower component is a wave-shaped structure, the number of bending sections of the wave-shaped structure is greater than 2, and there is at least one first distance between the upper component and the lower component, and the first distance is used to clamp the native heart valve.

12. The heart valve positioning device according to claim 1 or 2, It is characterized in that A side of the connecting portion away from the lower component is inclined toward the central axis of the positioning device.

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