CN218979341U - Prosthetic heart valve device and implantation system - Google Patents

Abstract

The present application provides a prosthetic heart valve device and an implantation system, the prosthetic heart valve device comprising: a flexible structure that in a released state forms a helically curved structure having a first dimension; a prosthetic valve, comprising: artificial valve leaves; and a support unit which is approximately cylindrical in a released state, the artificial valve She Zhouxiang being fixed to an inner surface of the support unit and being adapted to the flexible structure, wherein an outer surface of the support unit is provided with a ventricular anchoring structure comprising: a first extension member extending outwardly from an outer surface of the supporting unit in a direction away from the outer surface; and the second extension piece is connected with the first extension piece and extends from the first extension piece to the top direction of the supporting unit. The prosthetic heart valve device of the present application facilitates reducing the risk of left ventricular outflow end obstruction.

Description

Prosthetic heart valve device and implantation system

Technical Field

The embodiment of the application relates to the technical field of medical instruments, in particular to a prosthetic heart valve device and an implantation system.

Background

The mitral valve is complex in structure and consists of an annulus, leaflets, chordae tendineae and papillary muscles, any part of which is organically or functionally changed, and may cause mitral insufficiency, i.e., the mitral valve cannot be completely closed during systole, so that blood of the left ventricle reversely flows into the left ventricle. Mitral Regurgitation (MR) is the most common valve disorder. In the population over 75 years old, nearly 10% of people have MR. Although conventional mitral valve surgery is the first method of treatment for heart valve disease, MR with severe symptoms, up to 50% of patients are not suitable for surgery due to age and high risk of complications. The total mortality rate reported in non-operated patients is 50% for 5 years, and there is a great clinical need for minimally invasive surgery to treat patients with high risk MR or incapacitation of surgery. Most of the products on the market for MR patients are edge-to-edge repair products, such as MitralClip, and it is shown in some experiments that this formula cannot reduce the mortality of patients with partial functional reflux. And the rim-to-rim repair system, in addition to being limited to the patient, has further limitations in instrument application, including leaflet damage due to clip clamping, excessive left ventricular remodeling and subsequent sustained or recurrent MR phenomena. And mitral valve replacement surgery or procedures may be used to overcome these problems.

Valve replacement can be performed by surgical or transcatheter intervention, and for a part of patients with mitral insufficiency, the surgical operation is not applicable due to high risk factors such as heart dysfunction, complications, advanced age and the like, and the transcatheter intervention can be accepted for treatment. Although various structural designs and delivery modes have been developed in recent years for transcatheter mitral valves, most are under investigation, and the following limitations are major: because the mitral valve has a complex structure, compared with the aortic valve, the whole structure of the mitral valve is D-shaped, the size of the annulus is larger, calcification is less, and the artificial valve cannot be provided with enough supporting force, so that the artificial valve is fixed at the diseased mitral valve; anatomically, the left ventricular outflow end is adjacent to the anterior mitral leaflet, and implantation of a prosthetic mitral valve may also cause left ventricular outflow end obstruction (LVOTO); the mitral valve has a larger annulus size, the prosthetic valve requires a larger diameter stent, the prosthetic valve has a larger corresponding leaflet area, the leaflet fatigue resistance is reduced, and the size of the delivery device is increased, thereby increasing the risk of vascular complications.

The tricuspid valve is used as the atrioventricular valve of the right atrium, and has a structure similar to that of the atrioventricular valve (mitral valve) of the left atrium, and the same design principle applied to the valve for mitral valve replacement can be applied to tricuspid valve replacement.

Thus, there is a need for a product that does not require modification of the heart structure, while at the same time being able to treat valve regurgitation via a minimally invasive route.

Disclosure of Invention

In view of the above, the present application provides a prosthetic heart valve device and prosthetic valve implantation system that overcomes or at least partially solves the above-described problems.

The embodiment of the application provides a prosthetic heart valve device, which is connected with a conveying device and is used for conveying the prosthetic heart valve device to a heart by the conveying device when the prosthetic heart valve device is in a conveying state, and releasing the prosthetic heart valve device between native valve leaflets when the prosthetic heart valve device is in a releasing state. The prosthetic valve device includes: a flexible structure that in a released state forms a helically curved structure having a first dimension; a prosthetic valve, comprising: artificial valve leaves; and a support unit which is approximately cylindrical in a released state, the artificial valve She Zhouxiang being fixed to an inner surface of the support unit, and the support unit being adapted to the flexible structure, a ventricular anchoring structure being provided to an outer surface of the support unit, the ventricular anchoring structure comprising: a first extension member extending outwardly from an outer surface of the supporting unit in a direction away from the outer surface; the second extension piece is connected with the first extension piece and extends from the first extension piece to the top direction of the supporting unit; wherein the helically curved structure encircles the native leaflet when in the released state, the prosthetic valve is released inside the helically curved structure, at least a portion of the helically curved structure is positioned in a space formed by the first extension piece, the second extension piece, and the outer surface of the support unit.

Optionally, the second extension member extends from the first extension member in a direction substantially parallel to the central axis of the support unit.

Optionally, the second extension member extends from the first extension member in a direction approaching the outer surface of the support unit.

Optionally, the flexible structure comprises a plurality of coils, the helically curved structure being axially compressed.

Optionally, the second extension comprises: a first extension extending in a direction substantially parallel to a central axis of the support unit; and the second extension part is connected with the first extension part and extends from the first extension part to a direction approaching to the outer surface of the supporting unit.

The height of the second extension piece is 0.2cm-3cm.

Optionally, the top of the support unit is provided with an atrial anchoring structure extending from the top of the support unit in a direction away from the outer surface of the support unit such that the circumferential diameter of the end of the atrial anchoring structure is larger than the diameter of the support unit.

Optionally, the delivery device is provided with a pull wire, the ventricular anchoring structure is provided with a limiting piece, and the pull wire moves within a range limited by the limiting piece.

Optionally, the second extension piece further comprises a limiting hole, the pull wire passes through the limiting hole when the prosthetic valve is released, and the movement of the pull wire is limited by the limiting hole.

Optionally, the second extension member further includes a boss extending outward, the boss being adjacent to the first extension member for limiting movement of the pull wire between the first extension member and the boss.

Optionally, the outer diameter of the support unit is not less than the inner diameter of the flexible structure, and the inner diameter of the ventricular anchoring structure is not greater than the outer diameter of the expanded spiral curved structure compressed axially; in the transport state, the support unit is radially compressed to form a tubular or approximately bundle-like structure of smaller diameter.

Optionally, the support unit has a plurality of elastic structural units uniformly distributed along the circumference of the support unit, and each of the elastic structural units is deformable in both the major axis and the minor axis directions when subjected to a circumferential force.

Another aspect of the present application also provides a prosthetic heart valve implantation system, the system comprising: the above-described prosthetic heart valve device; a delivery device comprising a sheath for receiving and delivering the prosthetic heart valve device to the heart and releasing the prosthetic heart valve device.

Optionally, the conveying device further includes: the stay wire is movably connected with the supporting unit; and the control piece is connected with the stay wire and is used for controlling the second extension piece of the supporting unit through the stay wire so that the flexible structure is clamped in a space formed by the first extension piece, the second extension piece and the outer surface of the supporting unit.

According to the technical scheme, the flexible structure can be firstly conveyed into a human body at a large pitch so as to facilitate conveying and capturing the valve leaflets, and after the pitch of the flexible structure is compressed, the height of the flexible structure is reduced, so that the risk of blockage at the outflow end of the left chamber is reduced. Secondly, the ventricular anchoring structure enables a tighter holding force to be formed between the flexible structure and the supporting unit, so that impact of heart blood on artificial valve leaflets can be resisted together, a good perivalvular leakage prevention effect is provided, and meanwhile, the position stability of a human valve in the heart is ensured.

Drawings

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following description will briefly introduce the drawings that are required to be used in the embodiments or the description of the prior art, and it is obvious that the drawings in the following description are only some embodiments described in the embodiments of the present application, and other drawings may also be obtained according to these drawings for a person having ordinary skill in the art.

FIG. 1 is a schematic view of one embodiment of a prosthetic heart valve device of the present application;

FIG. 2A is a schematic view of an embodiment of a prosthetic valve of the present application after release;

FIG. 2B is a schematic diagram of one embodiment of a pull wire of a prosthetic heart valve device controlling the opening and closing of a ventricular anchoring structure;

FIG. 3 is a schematic view of another embodiment of a prosthetic valve of the present application;

FIG. 4 is a schematic view of yet another embodiment of a prosthetic valve of the present application;

FIG. 5 is a schematic view of another embodiment of a prosthetic heart valve device of the present application;

FIG. 6 is a schematic view of an embodiment of a boss of a second extension of the present application;

FIG. 7 is a schematic view of an embodiment of a limiting aperture of a second extension of the present application;

FIG. 8 is a schematic view of another embodiment of a limiting aperture of a second extension of the present application;

FIGS. 9 and 10 are schematic views of two further embodiments of ventricular anchoring structures, respectively;

FIGS. 11-12 are schematic views of the initial and complete release of the flexible structure of the present application;

FIG. 13 is a schematic illustration of an embodiment of a prosthetic valve of the present application in release;

fig. 14 is a cross-sectional view of a prosthetic valve of the present application after full release capturing the native leaflets.

Element labels

10: a prosthetic heart valve device; 20: a conveying device; 101: a flexible structure; 111: a coil; 111a: a ventricular coil; 111b: an atrial coil; 111c: a free end of the distal coil; 102: a prosthetic valve; 111d: a proximal coil; 122: a supporting unit; 132: a ventricular anchoring structure; 1321: a first extension; 1322: a second extension; c2: anterior and posterior commissures of native valve leaflets; 1323: a first extension; 1324: a second extension; 1221: an atrial anchoring structure; 201: a pull wire; 211: a control member; 1325: a connection hole; 1326: a limiting hole; 1327: a boss; 1222: an elastic structural unit; 140: a sealer; 202: a sheath.

Detailed Description

In order to better understand the technical solutions in the embodiments of the present application, the following descriptions will clearly and completely describe the technical solutions in the embodiments of the present application with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only some embodiments of the present application, but not all embodiments. All other embodiments obtained by a person of ordinary skill in the art based on the embodiments in the embodiments of the present application shall fall within the scope of protection of the embodiments of the present application.

By "proximal" is meant that the prosthetic heart valve device or component thereof is adjacent one end of the atrium or ventricle when the prosthetic valve assembly is implanted in the heart. By "distal" is meant the end of the prosthetic heart valve device or component thereof that is distal from the atrium or ventricle when the prosthetic valve assembly is implanted in the heart.

The "inflow end" and "outflow end" are relative to the direction of flow of blood from the atrium into the ventricle via the heart valve.

By "top" is meant that the support unit is near or at one end of the left atrium when the prosthetic valve is implanted in the heart, while "bottom" is relative to "top", i.e. the support unit is near or at one end of the left ventricle.

By "fit" is meant that the two components are structurally and/or shape-wise interfitted with or without a snap-fit relationship, interference fit, clearance fit, etc. between the two components.

Embodiments of the present application are further described below with reference to the accompanying drawings of embodiments of the present application.

Referring to fig. 1-14, in one embodiment of the present application, a prosthetic heart valve device 10 is provided that is coupled to a delivery device 20 for delivering the prosthetic heart valve device 10 to the heart via the delivery device 20 when in a delivery state and for releasing the prosthetic heart valve device 10 between native leaflets when in a release state. The prosthetic heart valve device 10 includes: a flexible structure 101 that in a released state forms a helically curved structure having a first dimension.

The "first dimension" refers to the dimension of the configuration formed in space after the flexible structure 101 is released, including the diameter of each coil, the pitch between adjacent coils, the height of the helically curved structure, and the like. The flexible structure 101 may include a plurality of helically wound coils 111, all of which coils 111 may be of equal diameter, non-equal diameter or varying diameter. For example, the diameter of the proximal and/or distal coils 111 may be greater than the diameter of the other coils 111, and the diameter of at least half of the distal (outflow) coils may be greater than the diameter of the other coils, which may be more advantageous for looping the native leaflet inside the flexible structure 101, reducing the difficulty of capturing the leaflet; the larger diameter of the proximal (inflow) coil 111 allows the proximal coil 111 to remain in the atrium after the primary leaflet is captured by the coil 111, helping to anchor the flexible structure 101 more firmly to the atrium; if the diameter of the proximal coil 111d is consistent with the diameter of the other coils, the proximal coil 111d may be provided with a smaller pitch than the adjacent coils, and the proximal coil 111d may be anchored to the atrioventricular orifice (near the annulus), thereby minimizing the overall structure of the prosthetic heart valve device 10, reducing the risk of the implant inducing thrombosis in the left atrium, and reducing the impact of the implant on the heart structure. If the coil 111 is positioned after the release of the heart, it may be divided into a ventricular coil 111a and an atrial coil 111b, where the ventricular coil 111a is at least two turns, the atrial coil 111b is at least 0.5 turn, and the atrial coil 111b may be a proximal coil 111d. The flexible structure 101 may be made of a material having memory properties, the flexible structure 101 is made into a spiral coil 111 in advance, the coil is stretched into a long curve when loaded in the delivery device 20, the coil 111 is slowly pushed out of the delivery device 20 when released, the coil 111 returns to a predetermined radius curve due to the memory properties, the coil 111 captures the native valve leaflet from the inner side of the native valve leaflet toward the outer side of the native valve leaflet (the side of the native valve leaflet toward the heart wall) as the coil 111 is continuously pushed out of the delivery device 20, the free end 111c of the distal coil gradually moves toward the heart side in a spiral motion, and after the release of the ventricular coil 111a is completed, the delivery device 20 is slowly retracted, and the atrial coil 111b is released, thereby completing the implantation of the flexible structure 101. The native leaflets may undergo a partial opening and closing motion inside the flexible structure 101 prior to implantation of the prosthetic valve.

The prosthetic heart valve device 10 further includes a prosthetic valve 102, the prosthetic valve 102 comprising: artificial leaflets (not shown); and a support unit 122, which is approximately cylindrical in a released state, the artificial valve She Zhouxiang is fixed to an inner surface of the support unit 122, and the support unit 122 is adapted to the flexible structure 101. In an embodiment of the present application, the outer diameter of the supporting unit 122 is greater than or equal to the inner diameter of the flexible structure 101, and the inner diameter of the ventricular anchoring structure 132 is not greater than the outer diameter of the expanded flexible structure after being axially compressed, so that when the supporting unit 122 is released inside the flexible structure 101, the supporting unit 122 is in interference fit with the flexible structure 101, forming a holding force and an axial friction force, and preventing the flexible structure 101 and the supporting unit 122 from moving relatively.

Since the function of the prosthetic valve 102 is to replace the native valve to function as a one-way valve, when the heart contracts, the prosthetic valve is closed due to the fact that the atrial pressure is less than the ventricular pressure, the prosthetic valve is impacted by the ventricular blood and is subjected to a great atrial pressure, the pressure is transferred to the support unit 122, and the pressure is opposite to the direction of the acting force applied to the coil 111 by the ventricular anchoring structure 132, and at least a part of the acting forces are offset, so that the risk that the support unit 122 is flushed to the atrium by the ventricular blood is reduced.

In the delivery state, the support unit 122 is radially compressed to form a tubular or approximately bundle-like structure of smaller diameter.

The outer surface of the support unit 122 is provided with ventricular anchoring structures 132, and the ventricular anchoring structures 132 may be provided at the bottom, the middle or any other suitable location of the support unit 122.

As shown in fig. 1-2, in this embodiment, the ventricular anchoring structure 132 includes: a first extending member 1321 extending outwardly from the outer surface of the supporting unit 122 in a direction away from the outer surface such that an extending end of the first extending member 1321 (i.e., an end away from the outer surface of the supporting unit 122) forms a diameter larger than the outer diameter of the supporting unit 122; the second extending member 1322 is connected to the first extending member 1321, and extends from the first extending member 1321 in a direction substantially parallel to the central axis of the supporting unit 122, including, but not limited to, the first extending member 1321 may extend from the outflow end to the inflow end, may extend from the inflow end to the outflow end, or both when extending in a direction substantially parallel to the central axis of the supporting unit 122. When in the released state, the helically curved structure is gradually released from the distal end to the proximal end and enters the outer surface of the native valve leaflet from the inner surface of the native valve leaflet via the native valve leaflet anteroposterior commissure C2 to capture the native valve leaflet, after which the prosthetic valve 102 is released inside the helically curved structure, at least a portion of the helically curved structure is positioned in the space formed by the first extension 1321, the second extension 1322 and the outer surface of the support unit 122, and the helically curved structure is axially compressed via the coactive force of the first extension 1321, the second extension 1322 and the outer surface of the support unit 122. The ventricular anchoring structures 132 may be distributed in plurality along the circumference of the support unit 122.

After the flexible structure 101 is released, the native valve leaflet is looped inside thereof, and the prosthetic valve 102 is implanted inside the native valve leaflet, whereby the flexible structure 101, the native valve leaflet and the prosthetic valve 102 together form a sandwich structure, and the native valve leaflet is sandwiched between the flexible structure 101 and the support unit 122 of the prosthetic valve 102.

In one embodiment of the present application, the flexible structure 101 may include a plurality of coils 111. The flexible structure 101 of the present application can be delivered into the body first with a large pitch (distance between adjacent coils) to facilitate delivery and capture of the leaflets, and then after the pitch of the coils is compressed, the height of the flexible structure 101 is reduced, which is beneficial to reducing the risk of left ventricular outflow end obstruction. If the pitch of the flexible structure 101 is too small, the distal end of the flexible structure 101 can easily enter the inner surface of the leaflet when passing through the anterior-posterior commissure C2 of the native leaflet during the release process, which results in failure of capturing the native leaflet, and the surgical time can be easily increased by withdrawing a part of the coil and then re-delivering the coil for capturing. Second, the ventricular anchoring structure 132 provides a tighter clasping force between the flexible structure 101 and the support unit 122, so that the impact of heart blood on the artificial valve leaflet can be jointly resisted, a good perivalvular leakage prevention effect is provided, and meanwhile, the position stability of the human valve in the heart is ensured.

The term "substantially parallel" includes that the second extension 1322 is completely parallel to the outer surface of the support unit 122 when the support unit 122 is released alone (i.e., without regard to the flexible structure 101). The "the second extension member 1322 extends from the first extension member 1321 in a direction approaching the outer surface of the supporting unit 122" includes that the second extension member 1322 is inclined toward the outer surface of the supporting unit 122 but does not contact the outer surface of the supporting unit 122 or that the second extension member 1322 is inclined toward the outer surface of the supporting unit 122 to contact the outer surface of the supporting unit 122. When the second extension 1322 extends from the first extension 1321 in a direction towards the outer surface of the support unit 122, the coil 111 is compressed axially due to the downward axial compression by the second extension 1322, so that the height of the flexible structure 101 and the prosthetic valve 102 is relatively low, thereby reducing the risk of obstruction of the outflow end of the left chamber. Since the coil 111 is compressed and deformed to a small pitch by the ventricular anchoring structure 132, the coil 111 tends to return to a large pitch, so that the coil 111 applies pressure to the ventricular anchoring structure 132 in the direction of the outflow end, and the axial friction force generated by the holding force between the supporting unit 122 and the coil 111 can resist the pressure of the coil 111 to the ventricular anchoring structure 132, so as to limit the pitch expansion of the coil 111. In the above-described embodiment, in the natural release state (i.e., the flexible structure 101 is released alone without being affected by the support unit 122), the pitch between adjacent coils of the flexible structure 101 is large, and when the flexible structure 101 and the support unit 122 are released successively to the heart, the helically-curved structure is compressed axially by the ventricular anchoring structure 132, and the pitch is thus compressed.

In another embodiment, the pitch between adjacent coils of the flexible structure 101 may be smaller in the naturally released state, and the coils deform under tension in the delivery system when they are threaded into the delivery system having a larger pitch, and the pitch becomes larger, and release to the ventricular side in such a larger pitch state, and return to the smaller pitch state when the larger pitch channel in the delivery system is withdrawn. The coil does not contact the first extension 1321 of the ventricular anchoring structure after being released to the heart, the coil is not compressed axially by the ventricular anchoring structure 132, and when the blood-impact support unit 122 moves to the left atrium, the ventricular anchoring structure 132 moves with the support unit 122 to the left atrium, thereby contacting the ventricular coil, having a tendency to compress the coil or beginning to compress the coil, so that the coil can also provide a reaction force, helping the support unit 122 resist the blood impact, reducing the risk of the prosthetic valve being flushed to the atrium.

The pitch between the center points of two adjacent layers of coils is called the pitch, and the height of the coil section in the axial direction (the axial center direction of the spiral structure formed by the whole coil) is called the wire diameter. In general, when the martensite reverse end temperature (Af) of the coil is lower than 30 °, the coil is referred to as a large pitch when the pitch is 2 times or more of the wire diameter, and is referred to as a small pitch when the pitch is less than 2 times of the wire diameter; when the Af of the coil approaches 37+/-7 DEG of human body temperature, the coil is slowly restored to a coiled state in the releasing process, the coil is easy to catch the native valve leaflet, and at the moment, the large pitch is defined as the line diameter with the pitch being more than or equal to 1.2 times, and the small pitch is defined as the line diameter with the pitch being less than 1.2 times. The coil may be rectangular, circular or other closed shape in cross-section.

As shown in fig. 3, the second extension 1322 includes: a first extending portion 1323 extending in a direction substantially parallel to the central axis of the supporting unit 122; the second extending portion 1324 is connected to the first extending portion 1323, and extends from the first extending portion 1323 in a direction approaching to the outer surface of the supporting unit 122 to form a U-shaped or C-shaped structure, and after the supporting unit 122 is completely released, the U-shaped or C-shaped structure limits a part of the coil in a space formed by the first extending member 1321, the second extending member 1322 and the outer surface of the supporting unit 122, and the coil is deformed by the space restriction of the outer surface of the supporting unit 122 and both sides of the first extending portion 1323 in addition to being restored to the high pitch state by the axial force applied thereto by the second extending portion 1324 and the first extending member 1321, so that the compressed state of the coil is maintained. The second extension 1324 compresses the coils from the top down, making the spacing between adjacent coils smaller, based on the first extension 1321 holding the flexible structure 101 from the bottom.

In an embodiment of the present application, the second extension member 1322 may also extend unidirectionally, and the distance between the second extension member 1322 and the outer surface of the supporting unit 122 and the elasticity of the second extension member 1322 may enable the second extension member 1322 to generate an axial compression force on the coil.

As shown in fig. 9, in the present embodiment, the second extending member 1322 is connected to the first extending member 1321, and the second extending member 1322 extends from the first extending member 1321 in a direction approaching to the outer surface of the supporting unit 122, and the connecting hole 1325 is provided at a free end of the second extending member 1322. The first extension 1321 and the second extension 1322 may form a single column, as shown in fig. 3, 5; the first extending member 1321 and the second extending member 1322 may also form two columns, as shown in fig. 8, where the first extending member 1321 extends outwardly from two positions of the outer surface of the supporting unit in a direction away from the outer surface, and the second extending member 1322 forms a V-shaped structure at the extending end (i.e., free end).

In another embodiment of the present application, the top of the support unit 122 is provided with an atrial anchoring structure 1221 extending from the top of the support unit 122 in a direction away from the outer surface of the support unit 122 such that the circumferential diameter of the end of the atrial anchoring structure 1221 is larger than the diameter of the support unit 122. The first extension 1321 holds the flexible structure 101 from the bottom and the atrial anchoring structure 1221 may compress the coils from the top down, making the spacing between adjacent coils smaller. The atrial anchoring structure 1221 may be U-shaped, W-shaped, wavy, or other shapes.

The delivery device 20 may be provided with a pull wire 201 and the ventricular anchoring structure 132 provided with a stop, the pull wire 201 being movable within the limits of the stop. For example, as shown in fig. 3, 5 and 8, the free end of the second extension member 1322 may be provided with a connection hole 1325, and the pull wire 201 may pass through the connection hole 1325 to control the opening angle of the second extension member 1322 with respect to the outer surface of the supporting unit 122. When the prosthetic valve 102 is released from the delivery device 20, the pull wire 201 is pulled to control the ventricular anchoring structure 132 to open at a proper angle, the coil 111 is positioned on the outer surface of the support unit 122, the second extension member 1322 is positioned on the outer side of the coil, then the prosthetic valve 102 is released continuously, the delivery device 20 can be operated to lift the support unit 122 towards the atrium, the native valve is lifted towards the atrium along with the native valve, the coil at the most distal end is supported by the first extension member 1321, and the retraction of part of the non-captured native valve in the ventricular anchoring structure 132 is realized, so that the movement of the native valve is further limited, the obstruction of the native valve to the left ventricular outflow end is reduced, the pitch of the coil 111 is reduced, and the height of the coil 111 is reduced. After the prosthetic valve 102 is completed, the pull wire 201 may be withdrawn, the pull wire 201 may be disengaged from the connection hole 1325, and the delivery device 20 may be withdrawn from the body passageway. After release of the prosthetic valve 102, the height of the second extension 1322 is about 0.2cm to about 3cm at about 0.8cm to about 3cm at the ventricular portion. In another embodiment, the delivery device 20 may not be provided with a pull wire 201.

Since the coil 111 is compressed and deformed to a small pitch by the ventricular anchoring structure 132, the coil 11 tends to return to a large pitch, and the ventricular anchoring structure 132 limits the coil 111 to return to a large pitch, so that the coil 111 applies pressure to the atrial anchoring structure 1221 in the direction of the outflow end, and an axial friction force generated by the holding force between the support unit 122 and the ventricular coil 111a resists the pressure of the coil 111 to the atrial anchoring structure 1221, so as to limit the deformation of the coil 111. Because the function of the artificial valve 102 is to replace a native valve to function as a one-way valve, the pressure of blood is small during diastole, and when the blood flows from the inflow end to the outflow end, the artificial valve is opened under the action of the blood, and the pressure exerted by the blood flow on the artificial heart valve device is small; when the heart contracts, when the heart chamber contracts and shoots blood, because the atrial pressure is smaller than the ventricular pressure to enable the artificial valve to be closed, the artificial valve is impacted by the heart chamber blood to bear great pressure in the direction of the heart chamber, the acting force in the direction of the heart chamber, which is borne by the artificial valve She Cheng, is transmitted to the supporting unit 122, the supporting unit 122 is acted by the acting force in the direction of the inflow end, and the acting force is opposite to the acting force applied to the heart chamber anchoring structure 132 and the supporting unit 122 by the coil 111, namely, the acting force of the compression coil 111 on the supporting unit 122 counteracts the impact force of part of blood on the supporting unit 122, and the risk that the supporting unit 122 is impacted to the atrium by the heart chamber blood is reduced. The delivery device 20 may be provided without a pull wire.

The ventricular anchoring structure 132 also has the function of limiting the support unit 122 from flying into the atrium when the prosthetic valve is subjected to ventricular blood impact.

Since the supporting unit 122 is released by releasing the ventricular anchoring structure 132 first, then releasing the supporting unit 122 and finally releasing the atrial anchoring structure 1221, the supporting unit 122 can be expanded to a larger diameter before being completely released by the atrial anchoring structure 1221, the supporting unit 122 can be effectively prevented from falling into the left ventricle due to the impact of blood or the action of gravity, and the possibility that the supporting unit 122 is released into the ventricle due to the whole supporting unit 122 due to the movement of the supporting unit 122 caused by the rapid change of the diameter of the supporting unit 122 in the releasing process of the supporting unit 122 can be reduced.

The outer diameter of the atrial anchoring structure 1221 is larger than the outer diameter of the ventricular coil 111 a. After the support unit 122 is released, the ventricular coil 111a is located between the atrial anchoring structure 1221 and the ventricular anchoring structure 132, and the coil 111 is limited in deformation by the atrial anchoring structure 1221 and the ventricular anchoring structure 132, except that the coil 111 cannot be restored to the high pitch state due to the axial friction between the ventricular coil and the support unit 122.

In another embodiment of the present application, a limiting hole 1326 (corresponding to the connecting hole 1325) may be provided in the second extension member 1322 near the first extension member 1321, where the pull wire 201 passes through the limiting hole 1326 when the prosthetic valve 102 is released, and the movement of the pull wire 201 is limited by the limiting hole 1326. In yet another embodiment of the present application, the second extending member 1322 includes a boss 1327 extending outward, and the boss 1327 is adjacent to the first extending member 1321 for limiting the movement of the cable 201 between the first extending member 1321 and the boss 1327. The limiting structure may be in the form of a slot or other form, etc. in addition to the limiting holes 1326 and bosses 1327 described above, to ensure that the control wire 201 can only move within the limiting area. Because the limiting hole 1326 and the boss 1327 are disposed at a position close to the first extending member 1321, that is, a position close to the outflow end of the supporting unit 122, the length of the stay wire 201 is shorter than the length of the stay wire 201 required for connecting the connecting hole 1325 to the free end of the second extending member 1322, which is beneficial to precisely controlling the stay wire 201 and reducing the loss of a certain opening angle of the second extending member 1322 caused by deformation of the stay wire 201.

In an embodiment of the present application, the support unit 122 has a plurality of elastic structural units 1222, and the plurality of elastic structural units 1222 are uniformly distributed along the circumference of the support unit 122, and each elastic structural unit 1222 can be deformed in both the major axis and the minor axis directions when receiving a circumferential force. For example, when subjected to a compressive force, the long axis of each elastic structural unit 1222 is longer and the short axis is shorter, i.e., the elastic structural unit 1222 is pressed into a long strip shape, and the support unit 122 is radially compressed into a tubular or bundle-like structure having a smaller diameter. The shape of the elastic construction element 1222 in the released state may be diamond, parallelogram, hexagon or any other suitable shape.

As shown in fig. 10, optionally, the outer and/or inner surfaces of the support unit 122 and at least a portion of the ventricular anchoring structure 132 may be coated with a polymeric material (e.g., PET, PTFE) or treated animal-derived tissue, may fill the gap between the support unit 122 and the flexible structure 101, and act as a seal, increasing friction therebetween, and increasing the anchoring force of the prosthetic valve 102 to the flexible structure 101 while reducing paravalvular leakage. At the same time, the materials are beneficial to climbing skin of cells in the heart, realizing the endothelialization of the prosthesis, and after realizing the endothelialization, strengthening the fixation of the artificial valve 102 in the heart. The elastic construction units 1222 may be diamond-shaped, parallelogram-shaped, hexagonal-shaped, combinations thereof, or any other suitable shape.

An embodiment of the present application also provides a prosthetic heart valve implantation system, comprising: the prosthetic heart valve device 10 described above; a delivery device 20 including a sheath 202 for receiving and delivering the prosthetic heart valve device 10 to the heart and releasing the prosthetic heart valve device 10.

The conveying apparatus 20 further includes: the connecting piece is movably connected with the supporting unit 122 and can be a pull wire 201; and a control member 211 connected to the stay wire 201 for controlling the second extending member 1322 of the support unit 122 via the stay wire 201 such that the flexible structure 101 is clamped in a space formed by the first extending member 1321, the second extending member 1322 and the outer surface of the support unit 122.

The flexible structure 101 and the artificial valve 102 are sequentially released from the position of the primary valve through the septum, and are the same delivery path, so that the risk of vascular injury of a patient can be reduced, and the body recovery after operation is facilitated by a single opening.

At least a portion of the ventricular anchoring structure 132 and the supporting unit 122 is coated with the sealing material 140, the surface of the ventricular anchoring structure 132 can also be coated with a braided fabric, so that heart tissue is prevented from being damaged in the release process, the sealing material 140 and the braided fabric can be made of biocompatible high polymer materials (such as PET (polyethylene terephthalate) and PTFE (polytetrafluoroethylene), which are beneficial to climbing of cells in the heart, realizing the endothelialization of the prosthesis, and reinforcing the fixation of the prosthetic valve in the heart after the endothelialization is realized. The seal 140 may prevent the ventricular anchor structure 132 and the support unit 122 from scratching the native heart tissue during delivery, while increasing the tightness and friction between the ventricular anchor structure 132 and the support unit 122 and the native leaflets.

As shown in fig. 14, in one embodiment of the present application, a method of implanting a prosthetic heart valve device 10 includes: the delivery device 20 loaded with the flexible structure 101 enters the ventricle through the femoral artery access, the catheter entering the human body through the femoral artery is placed under the valve annulus of the mitral valve, the pushing coil rotates and stretches out along the direction of the ventricle under the valve annulus, a strong developing point can be arranged at a certain position on the coil at the proximal end so as to facilitate observation and control of the release of the coil, then the artificial valve 102 is released through the atrial septum, after the artificial valve 102 is released, the delivery device 20 slowly withdraws and dissociates the control of the coil, and the coil is completely released.

Unlike fig. 14, as shown in fig. 11-13, the flexible structure 101 and the prosthetic valve 102 are both delivered to the native valve site via the atrial septum, and are the same delivery path, and the flexible structure 101 and the prosthetic valve 102 are released in sequence, so that the risk of vascular injury of the patient can be reduced, and the single opening is beneficial to the postoperative body recovery.

Finally, it should be noted that: the above embodiments are only for illustrating the technical solutions of the embodiments of the present application, and are not limited thereto; although the present application has been described in detail with reference to the foregoing embodiments, it should be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit and scope of the corresponding technical solutions.

Claims (14)

1. A prosthetic heart valve device coupled to a delivery device for delivering the prosthetic heart valve device to a heart via the delivery device when in a delivery state and for releasing the prosthetic heart valve device between native leaflets when in a release state, the prosthetic heart valve device comprising:

a flexible structure that in a released state forms a helically curved structure having a first dimension;

a prosthetic valve, comprising:

artificial valve leaves; and

a support unit which is approximately cylindrical in a released state, the artificial valve She Zhouxiang being fixed to an inner surface of the support unit and the support unit being adapted to the flexible structure;

a ventricular anchoring structure provided on an outer surface of the supporting unit, the ventricular anchoring structure comprising:

a first extension member extending outwardly from an outer surface of the supporting unit in a direction away from the outer surface;

the second extension piece is connected with the first extension piece and extends from the first extension piece to the top direction of the supporting unit;

wherein the helically curved structure encircles the native leaflet when in the released state, the prosthetic valve is released inside the helically curved structure, at least a portion of the helically curved structure is positioned in a space formed by the first extension piece, the second extension piece, and the outer surface of the support unit.

2. The prosthetic heart valve device of claim 1, wherein the second extension member extends from the first extension member in a direction generally parallel to a central axis of the support unit.

3. The prosthetic heart valve device of claim 1, wherein the second extension member extends from the first extension member in a direction proximate the outer surface of the support unit.

4. The prosthetic heart valve device of claim 1, wherein the flexible structure comprises a plurality of coils, the helically curved structure being axially compressed.

5. A prosthetic heart valve device according to claim 3, wherein the second extension comprises:

a first extension extending in a direction substantially parallel to a central axis of the support unit;

and the second extension part is connected with the first extension part and extends from the first extension part to a direction approaching to the outer surface of the supporting unit.

6. The prosthetic heart valve device of claim 1, wherein the second extension has a height of 0.2cm to 3cm.

7. The prosthetic heart valve device of claim 1, wherein the top of the support unit is provided with an atrial anchoring structure extending from the top of the support unit in a direction away from the outer surface of the support unit such that the circumferential diameter of the end of the atrial anchoring structure is greater than the diameter of the support unit.

8. The prosthetic heart valve device of claim 1, wherein the delivery device is provided with a pull wire and the ventricular anchoring structure is provided with a stop member, the pull wire being movable within the limits of the stop member.

9. The prosthetic heart valve device of claim 8, wherein the second extension member further comprises a limiting aperture through which the pull wire passes when the prosthetic valve is released, whereby movement of the pull wire is limited by the limiting aperture.

10. The prosthetic heart valve device of claim 8, wherein the second extension member further comprises an outwardly extending boss adjacent the first extension member for limiting movement of the pull wire between the first extension member and the boss.

11. The prosthetic heart valve device of claim 1, wherein the support element has an outer diameter that is not less than an inner diameter of the flexible structure, and wherein the inner diameter of the ventricular anchoring structure is not greater than an outer diameter of the expanded spiral curved structure that is axially compressed; in the transport state, the support unit is radially compressed to form a tubular or approximately bundle-like structure of smaller diameter.

12. The prosthetic heart valve device of claim 1, wherein the support element has a plurality of resilient structural elements uniformly distributed about a circumference of the support element, each of the resilient structural elements being deformable in both the major and minor axes when subjected to a circumferential force.

13. A prosthetic heart valve implantation system, the system comprising:

the prosthetic heart valve device of any one of claims 1-12;

a delivery device comprising a sheath for receiving and delivering the prosthetic heart valve device to the heart and releasing the prosthetic heart valve device.

14. The prosthetic heart valve implantation system of claim 13, wherein the delivery apparatus further comprises:

the stay wire is movably connected with the supporting unit;

and the control piece is connected with the stay wire and is used for controlling the second extension piece of the supporting unit through the stay wire so that the flexible structure is clamped in a space formed by the first extension piece, the second extension piece and the outer surface of the supporting unit.

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