CN116019609A - Aortic valve - Google Patents

Abstract

The invention relates to an aortic valve, which comprises a bracket body, a positioning ring and connecting wires, wherein the bracket body comprises a top connecting rod and a multi-layer hole type supporting structure; the far end of the multi-layer hole type supporting structure is provided with a first layer hole type supporting structure, the first layer hole type supporting structure comprises a plurality of first layer supporting holes, and the adjacent first layer supporting holes are fixedly connected together through first nodes; the positioning ring consists of a plurality of connecting rods which are sequentially connected end to end, and the adjacent connecting rods are connected together through arc-shaped connecting sections; the arc-shaped connecting section is provided with a connecting hole; one end of the connecting wire is fixedly connected to the first node; the other end of the connecting wire is fixedly connected in the connecting hole; the length of the connecting wire is such that when the positioning ring reaches the sinus bottom of the native valve leaflet, the position of the bracket body connected with the positioning ring through the connecting wire also just reaches the position capable of perfectly clamping the native valve leaflet with the positioning ring.

Description

Aortic valve

Technical Field

The invention relates to the technical field of medical equipment, in particular to an aortic valve.

Background

The following is merely representative of the background art which the inventors themselves have grasped, and is not a prior art which is readily available to the public.

Transcatheter aortic valve implantation (Transcatheter Aortic Valve Implantation, TAVI) has become an alternative to surgery for the treatment of severe aortic valve stenosis due to its safety, minimal trauma, rapid recovery, etc. Transcatheter Aortic Valve Implantation (TAVI) refers to delivering a prosthetic heart valve to an aortic valve region via a femoral artery into an interventional catheter and opening the valve region, thereby completing prosthetic valve implantation and restoring valve function. The most widely used products in clinical TAVI surgery are the balloon expandable Sapien valve stent series from Edwards corporation in the united states and the self-expanding CoreValve valve from Medtronic corporation in the united states. The two valves are designed primarily for treating patients with aortic stenosis. Currently TAVI is limited to patients with severe aortic stenosis, and aortic insufficiency is still listed as a contraindication to TAVI. There have been researchers attempting to use CoreValve self-expanding stents and Sapien valve stents in patients with simple aortic insufficiency, and as a result, it has been found that the stent placement is inaccurate and the incidence of implantation is as high as 20%, both of which have been substantially no longer applicable to patients with aortic insufficiency.

In the prior art, chinese patent publication No. CN105496607a discloses an aortic valve apparatus, the structure of which is schematically shown in fig. 1A and 1B, in which a positioning ring 103, a positioning wire 107, a head end 201, a loading sheath 202, a natural leaflet tissue 300 of a human body, and the like are shown. The aortic valve device disclosed in this document employs a tandem loading structure with a connecting wire attached to the distal end of the stent body. Because the self-expanding stent made of nickel-titanium alloy is adopted, when the loading sheath is withdrawn proximally, the self-expanding stent can be released to the position A shown in the figure 1A at most, and if the self-expanding stent is released proximally again, the stent body can be automatically expanded under the characteristic of shape memory alloy, so that the positioning ring cannot be utilized for positioning.

Because the connecting wire is connected to the distal end of the stent body, in the state of fig. 1B, the connecting wire can form a problem of "crossing petals", the connecting wire and the self-petals of the human body have larger mutual interference, the positioning effect is actually weaker, and the effect of providing positioning through the positioning ring is extremely limited due to the interference influence of the self-petals of the human body. And the actual connecting wires can be very tedious, and both viewing and surgical procedures under DSA contrast are relatively difficult.

The chinese patent publication No. CN110507451a discloses a valve stent and a prosthetic valve with the same (as shown in fig. 2, wherein the stent body 1 and the positioning ring 6 are shown), the connecting wire is made of nitinol, however, after multiple tests, it is found that after the connecting wire made of nitinol is implanted in the heart of an animal, abnormal tissue proliferation can be observed after 2 to 3 months, and after numerous improvements and tests, the problems cannot be solved. After the medical suture is adopted for replacement, the problem of abnormal tissue proliferation is found to be relieved.

In the technical solution disclosed in document CN110507451a, the risk of blockage of the coronary artery by the native valve leaflet is avoided, because the valve leaflet is clamped by the positioning ring and the stent body, rather than being extruded in an outboard state as in the self-expanding stent. The occurrence rate of coronary artery blockage in the TAVI operation in the prior art is about 0.2 to 0.4 percent, and the structural design correlation degree of the TAVI operation and the valve stent is higher.

In the technical solution disclosed in document CN110507451a, there is little supporting extrusion of the inner wall of the ascending aorta, greatly reducing the risk of problems of conduction block. Cardiac conduction block refers to the slowing or blocking of conduction of impulses at any location in the cardiac conduction system. Direct compression of the conduction system by aortic valve stents is the most critical factor in new conduction barriers following TAVI surgery, which occur at very long self-expanding stents implanted in the left ventricular outflow tract (typically Corevalve stents, which mechanically compress the conduction system 4mm to 6mm deep into the left ventricle, resulting in conduction block).

In the technical solution disclosed in document CN110507451a, the stent body is made of a cobalt-chromium alloy material, which does not have a shape memory function, and only the positioning ring expands and opens due to self-expansion after the loading sheath is retracted proximally, so that the connecting wire can be connected to the middle part of the stent body. Because the cobalt-chromium alloy material is adopted, the bracket body needs to be spread by using the balloon, so that the overall conveying diameter of the conveying system is longer, and better patient adaptation cannot be provided through a perfect size.

Disclosure of Invention

The invention aims to provide an aortic valve, which aims to solve the technical problems of avoiding the problem that a stent body cannot be positioned by using a positioning ring due to the fact that the stent body is automatically unfolded under the characteristic of a shape memory alloy, avoiding the problem that a connecting wire forms a cross valve, avoiding abnormal tissue hyperplasia, prompting a surgeon that the positioning ring is positioned to the sinus floor through force feedback, providing effective positioning for the stent body and avoiding the occurrence of conduction block.

The invention aims to solve the defects in the prior art and provides an aortic valve, which comprises a bracket body, a positioning ring and connecting wires, wherein the bracket body comprises a top connecting rod and a multi-layer hole type supporting structure; the far end of the multi-layer hole type supporting structure is provided with a first layer hole type supporting structure, the first layer hole type supporting structure comprises a plurality of first layer supporting holes which are arranged along the circumferential direction of the bracket body, and the adjacent first layer supporting holes are fixedly connected together through a first node; the positioning ring consists of a plurality of connecting rods which are connected end to end in sequence, and the adjacent connecting rods are connected together through arc-shaped connecting sections; the arc-shaped connecting section is provided with a connecting hole; one end of the connecting wire is fixedly connected to the first node; the other end of the connecting wire is fixedly connected in the connecting hole; the length of the connecting wire is such that when the positioning ring reaches the sinus bottom of the native valve leaflet, the position of the bracket body connected with the positioning ring through the connecting wire also just reaches the position capable of perfectly clamping the native valve leaflet with the positioning ring.

Preferably, a U-shape or a V-shape is formed between the adjacent connecting rods.

Preferably, the multi-layer hole type supporting structure comprises a first layer hole type supporting structure, a second layer hole type supporting structure, a third layer hole type supporting structure, a fourth layer hole type supporting structure and a fifth layer hole type supporting structure which are sequentially arranged from the far end to the near end, wherein the third layer hole type supporting structure comprises a plurality of third layer supporting holes which are arranged along the circumferential direction of the bracket body, and leaflet sewing lugs and/or bracket rods are arranged between the adjacent third layer supporting holes.

Preferably, two connecting holes are arranged on each arc-shaped connecting section.

Preferably, the connecting rod on be provided with a plurality of protruding nodes, be fit for the suture winding between the adjacent protruding node to protruding node be used for preventing that the suture of winding from taking place displacement or stacking because of receiving friction or extrusion, the winding suture here is in order to reduce holding ring and support body direct contact, avoids producing friction and wearing and tearing support body because of holding ring and support body between.

Preferably, a platinum iridium alloy wire is wound between adjacent protruding nodes, a suture is wound outside the platinum iridium alloy wire, and the platinum iridium alloy wire is used for developing and observing in an operation.

Preferably, the distal end of the stent body has a flaring structure to adapt to the natural physiological structure of the human body.

Preferably, the positioning ring and the bracket body are used for clamping the self-leaflet.

Preferably, the bracket body is made of nickel-titanium alloy.

Preferably, the connecting wires are connected with the positioning ring and the bracket body in a structure that the knot is positioned at the inner side and the outer side is kept smooth.

Advantageous effects

Compared with the prior art, the invention has the beneficial effects that:

1. when the positioning ring reaches the sinus bottom of the self valve leaflet, a weak force feedback which can be perceived by an operator is formed through the traction of the connecting wires, so that the operator is prompted that the positioning ring is positioned to the sinus bottom, and the length of the connecting wires selected after certain calculation can enable the position of the bracket body connected with the positioning ring through the connecting wires to just reach the position which can perfectly clamp the self valve leaflet with the positioning ring when the positioning ring reaches the sinus bottom of the self valve leaflet, thereby further providing effective positioning for the bracket body. Compared with the longer connecting wire in the document CN105496607A, the connecting wire is hardly influenced by the interference of the self-body valve leaflet, and the connecting wire is not influenced by the interference of the self-body valve leaflet, so that the connecting wire can provide clearer force feedback and can provide an operator with the effect of knowing that the positioning ring reaches the sinus floor. The positioning/stopping of the stent body is realized through the positioning ring, so that the distal end of the stent body can be thoroughly prevented from being implanted into the aortic orifice too deeply, and the occurrence of conduction block is avoided.

2. In the aortic valve, due to the existence of the clamping jaws at the distal end of the stent, when the connecting wires are tied in the middle of the stent body, the loading sheath is retracted, and the stent body cannot be opened.

3. In the aortic valve, the connecting wire, the positioning ring and the stent body are connected by the knot 61 on the inner side, and the outer side 62 is kept smooth, so that the loading sheath can smoothly slide over the connecting part of the connecting wire, the stent body and the positioning ring when the aortic valve is recovered.

Drawings

The accompanying drawings are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate and do not limit the invention.

Fig. 1A and 1B are schematic structural views of an aortic valve apparatus in the prior art.

Fig. 2 is a schematic structural view of a valve stent and a prosthetic valve having the same in the prior art.

Fig. 3 is a schematic view of the overall structure of the aortic valve according to the present invention.

Fig. 4 is a schematic structural view of the bracket body 11 according to the present invention.

Fig. 5 is a schematic view of the positioning ring 12 according to the present invention.

Fig. 6 is a schematic view of the overall structure of the aortic valve according to the invention in the expanded state.

Fig. 7 is an enlarged schematic view of a leaflet sewing ear according to the present invention.

Fig. 8 is an enlarged schematic view of the bracket bar according to the present invention.

Fig. 9 is a schematic structural view of the holder body 11 of the variable diameter plate according to the embodiment.

Fig. 10 is a complete perspective view of the delivery system of the present invention.

Fig. 11 is a perspective view of a delivery system according to the present invention (hidden loading sheath).

Fig. 12 is an enlarged schematic view of the distal jaw of the stent according to the present invention (hiding the loading sheath).

Fig. 13 is a partial schematic view of the delivery system assembled with the aortic valve holder (loaded state, with the loading sheath hidden).

Fig. 14 is a partial schematic view of the delivery system assembled with the aortic valve (semi-released state showing the loading sheath).

Fig. 15 is an enlarged schematic view of the structure of the arc-shaped connecting section 121 according to the present invention.

Fig. 16 is a schematic structural view of a carrier film according to the present invention.

Fig. 17 is a schematic view of the structure of the leaflet of the present invention.

Fig. 18 is a schematic view of the leaflet and base film attachment of the present invention.

Detailed Description

The present invention is described in more detail below to facilitate an understanding of the present invention.

As shown in fig. 3 to 6, the aortic valve according to the present invention comprises a stent body 11, a positioning ring 12 and a connecting wire 13, wherein the stent body 11 comprises a top connecting rod 1 and a multi-layer hole type supporting structure, and the top connecting rod 1 is fixedly arranged at the proximal top of the multi-layer hole type supporting structure; the far end of the multi-layer hole type supporting structure is provided with a first layer hole type supporting structure 111, the first layer hole type supporting structure 111 comprises a plurality of first layer supporting holes which are arranged along the circumferential direction of the bracket body 11, and the adjacent first layer supporting holes are fixedly connected together through a first node 116; the positioning ring 12 is composed of a plurality of connecting rods 120 which are connected end to end in sequence, and the adjacent connecting rods 120 are connected together through arc-shaped connecting sections 121; the arc-shaped connecting section 121 is provided with a connecting hole 122; one end of the connecting wire 13 is fixedly connected to the first node 116; the other end of the connecting wire 13 is fixedly connected in the connecting hole 122; the length of the connecting wire 13 is such that when the positioning ring reaches the sinus bottom of the native valve leaflet, the position of the stent body connected with the positioning ring through the connecting wire also just reaches the position where the native valve leaflet can be perfectly clamped with the positioning ring.

Preferably, a U-shape or a V-shape is formed between the adjacent connection bars 120.

Because one end of the connecting wire 13 is fixedly connected to the first node 116 (it is noted that the connecting wire is similar to the positioning ring, the connecting wire is tied on the inner side, which is beneficial to smoothness in recovery), rather than connecting the connecting wire to the far end of the bracket body as in the prior art, the problem that the connecting wire forms a cross valve is avoided, and interference influence of human body self valve leaves is avoided.

In the embodiment shown in fig. 4, the multi-layered hole pattern support structure includes a first layer hole pattern support structure 111, a second layer hole pattern support structure 112, a third layer hole pattern support structure including a plurality of third layer support holes arranged along the circumferential direction of the stent body 11, a fourth layer hole pattern support structure 113, and a fifth layer hole pattern support structure 114 sequentially disposed from the distal end to the proximal end, and leaflet sewing ears 117 and/or stent rods 118 disposed between the adjacent third layer support holes.

The top of fifth layer hole pattern support structure 114 is fixedly attached to free end 115.

The enlarged view of portion a in fig. 7 shows leaflet tab 117. Fig. 8 shows another alternative, in the embodiment shown in fig. 8, the leaflet sewing ear can be eliminated and the leaflet can be sewn directly onto the stent rod 118.

In the embodiment shown in fig. 5, two connecting holes 122 are provided in each arcuate connecting section 121.

As shown in fig. 5, the connecting rod 120 is provided with a plurality of protruding nodes 123, and the adjacent protruding nodes are suitable for suture winding, and the protruding nodes are used for preventing the wound suture 124 from being displaced and stacked due to external forces such as friction and extrusion, so that the wound suture is used for reducing direct contact between the positioning ring and the bracket body, avoiding friction between the positioning ring and the bracket body and wearing the bracket.

In an alternative embodiment, the wrapping between adjacent raised nodes can be achieved by wrapping around a suture, or by wrapping around a polymeric "scrim" such as a polyester material, to avoid direct contact of the retaining ring with the stent body; in embodiments employing "scrim" wrapping, the raised nodes may more effectively prevent "scrim" slippage and stacking.

In another preferred embodiment, the retaining ring is not straight, but has an inner arcuate bend, the diameter of the proximal side of the retaining ring (the side on which the arcuate connecting section 121 is located) is equal to the diameter of the stent body, and the diameter of the distal side of the retaining ring (the side on which the platinum iridium alloy wire 128 is located in fig. 5) is smaller than the diameter of the stent body; by adopting the design of the shape, the positioning ring and the bracket body can form stronger clamping effect, the self valve leaflet is firmly clamped, and the anchoring effect is realized.

In the embodiment shown in fig. 5, 3 pairs of boss nodes, respectively a first boss node 125, a second boss node 126, and a third boss node 127, are provided on each connecting rod 120. The bump nodes may also be 1 pair, 2 pairs, or 4 pairs.

Preferably, a platinum iridium alloy wire 128 is wound between adjacent protruding nodes, a suture is wound on the outer portion of the platinum iridium alloy wire, and the platinum iridium alloy wire is used for developing and observing in operation.

Preferably, as shown in fig. 9, the distal end of the stent body 11 has a certain flaring to adapt to the natural physiological structure of the human body.

As shown in fig. 10, in the loading state, the holder body 11 and the positioning ring 12 are disposed in series in the loading sheath.

In the prior art disclosed in document CN105496607a, since a self-expanding stent made of nitinol is adopted, when the loading sheath is withdrawn proximally, the stent can be released to the position a shown in fig. 1A at most, and if the stent is released proximally again, the stent body will be automatically opened under the characteristic of the shape memory alloy, so that the positioning by the positioning ring cannot be performed.

In order to solve the above problems, the present application provides a stent distal end claw 30 in a delivery system, which can clamp a stent distal end to prevent a stent body from expanding in advance, as shown in fig. 13 and 14. Due to the existence of the clamping jaw at the far end of the bracket, when the connecting wire is tied at the middle part of the bracket body, the loading sheath is retracted, and the bracket body can not be opened.

In the prior art, a study involving 220 low risk patients implanted with evoout valves showed that 42.7% of TAVR patients (94) had more than 1 severe coronary artery access overlap. Because aortic valve patients mostly incorporate coronary disease, the effect of TAVR on coronary access is often alarming, especially when the annulus level is designed to be higher than the native annulus biological valve. It should be noted that in clinical decisions, the choice of type and implantation depth of the biological valve is often determined by the anatomy of the root of the artery, and when using a high frame, long skirt valve in surgery for patients with small coronary openings, the operator should pay more attention to the precise apposition of the junctions between the biological valve and the native valve in order to reduce the likelihood of covering the coronary passages.

In addition to shielding the coronary artery access, due to the pathological reasons of the aortic heart valve, the patient often accompanies the coronary artery disease of the first occurrence or the later occurrence, after the treatment of the valve disease, the coronary artery operation is still needed to be performed with higher probability, and even if the shielding area is smaller, the coronary artery access can still be possibly caused to be incapable of being performed due to partial shielding when the subsequent patient needs to perform the coronary artery operation.

In this application, owing to adopted the technical scheme of holding self valve leaf of holding ring and support body, its required not to the holding power of self valve leaf, but to the holding power of self valve leaf, therefore actual support body height H is shorter than all supports on comparison literature and the market, has short support characteristic.

The actual height refers to the height of the sewn carrier film, and as shown in fig. 4, at a portion higher than H, the carrier film (i.e., skirt) may be sewn without or with a small portion, with little effect on the hemodynamics at the coronary artery.

In the technical solution disclosed in the document CN105496607a, although the positioning ring and the bracket body have similar structures, the function of the positioning ring is only used for positioning, and no clamping effect is provided.

The effects of over-expansion are also considered important, and experiments have shown that over-expansion, in which the valve leaflets are significantly restricted, is particularly evident in smaller valves. A small She Silie can be observed after a maximum 26mm valve over-dilation.

In this application, since the stent body is made of nickel-titanium alloy, the risk of leaflet tearing is solved compared with cobalt-chromium alloy materials (i.e., the same materials as SAPIEN3 mentioned in the prior art documents) used in the prior art (document CN110507451 a).

Compared with the technical scheme disclosed in the document CN110507451A, the invention solves the problem of abnormal tissue hyperplasia caused by the elastic connecting wire on one hand, and avoids the problem that the self valve leaflet of the human body is torn in the balloon expanding process caused by the cobalt-chromium alloy stent body in the CN110507451A on the other hand (small She Silie).

As shown in fig. 15, in the present application, the connection structure between the connection wire and the positioning ring and the support body is that the knot 61 is located at the inner side, while the outer side 62 is kept in a smooth structure, so that the loading sheath can smoothly slide over the connection part between the connection wire and the support body and the positioning ring when being recovered.

In addition, in the present application, the connecting wire may be one wire or two wires.

When a single wire is used, the two ends of the single wire are connected to the stent body through the two connecting holes 122 of each of the arc-shaped connecting sections 121 shown in fig. 5. Or a wire which is reversely connected with the bracket body after bypassing the space between the two holes for a circle.

When two wires are used, a first wire passes through the first connection hole 122 of the arc-shaped connection section 121, and then both ends of the first wire are connected to the stent body. The second wire passes through the second connection hole 122 of the arc-shaped connection section 121, and then both ends of the second wire are connected with the stent body.

In the embodiment shown in fig. 8, the leaflet sewing ear is eliminated and the leaflet is sewn directly onto the stent rod 118. To ensure stability after leaflet suturing, the present application provides the preferred embodiment shown in fig. 16-18.

As shown in fig. 16 to 18, the structure of the conventional leaflet and the basement membrane in the market is greatly changed, and the sewing connection between the leaflet and the basement membrane is realized by adopting the components shown in fig. 18, so that the stability of the leaflet after sewing and the sealing performance of the basement membrane can be ensured under the condition that the leaflet is not used for sewing the ear, and the performance is excellent through fatigue test.

The advantages achieved by the present invention can be further elucidated by comparing in detail with the technical solution disclosed in document CN105496607a (hereinafter referred to as document 1).

The technical solution disclosed in document CN105496607a is the following procedure:

(1) the positioning ring is released in a horn shape (as shown in fig. 8 of document 1), and the positioning ring 103 of the aortic valve apparatus 100 is half-released by moving the loading sheath 202 of the delivery system 200 to a fixed position by the handle 203 in accordance with the description of the same, and at this time, the positioning ring 103 is automatically expanded to form a horn shape due to the shape memory property of the material of the aortic valve apparatus 100 (see fig. 5 and 8 of document 1).

Obviously, the reason for the flare of the retaining ring is that the proximal end of the retaining ring (upper end in the figure) is constrained by the loading sheath and cannot be opened.

(2) The horn-shaped positioning ring is pushed to the bottom of the natural valve leaflet tissue of the human body, and the delivery system 200 is pushed to the ventricular side slowly according to the description of the horn-shaped positioning ring, so that the positioning ring 103 contacts the bottom of the natural valve leaflet tissue 300 of the human body, and the delivery system 200 is stopped.

It is noted that this process is not shown in the drawing of document 1.

(3) The positioning ring is completely released (as shown in fig. 9 of document 1), and the loading sheath 202 of the delivery system 200 is moved back again to the fixed position by the handle 203 corresponding to the description thereof, so that the positioning ring 103 is completely released from the loading sheath 202, and at this time, the positioning ring 103 is completely automatically expanded to the maximum size due to the shape memory property of the material (see fig. 6 and 9 of document 1).

It is worth noting that in the process of thoroughly releasing the positioning ring, the positioning ring which is originally constrained by the loading sheath can be sprung out to the maximum size instantly, and the positioning wire is very flexible material, so that the buffering constraint can not be formed on the sprung-out positioning ring. Obviously, the act of carefully positioning the positioning ring to the bottom of the natural leaflet tissue 300 of the human body in step (1) and step (2) is very prone to one step due to the bouncing of the positioning ring when it bounces.

(4) The delivery system is pushed until the positioning wire is tightened (as shown in fig. 10 of document 1), and the delivery system 200 is also in a limited state (see fig. 10 of document 1) in response to the description of "continuing to push the delivery system 200 in the ventricular direction so that the loading sheath 202 passes over the natural leaflet tissue 300 of the human body until the positioning wire 107 is in a tightened state".

It is worth noting that, from a proprietary standpoint only, the process of tightening the alignment wire can be understood as: the distal end (lower end) of the positioning ring connected to one end of the positioning wire is already abutted against the bottom of the natural leaflet tissue 300 of the human body, and the movement to the distal end (lower end) cannot occur any more, i.e. the one end of the positioning ring of the positioning wire is limited. The other end of the positioning wire is connected to the main support, obviously, when the main support is further pushed by the conveying system, the positioning wire is gradually stretched, and when the conveying system is pulled by the stretched positioning wire and cannot move any further, the main support is accurately positioned. The above is an ideal scenario assumed in document 1, however, there is a clear problem from the viewpoint of actual surgery, and first, the length of the positioning wire in document 1 is long, and the positioning wire inevitably interferes with the natural leaflet of the human body in the state shown in fig. 10 in document 1, regardless of the physical principle necessary in the operation thereof or the situation shown in the drawings. Secondly, the positioning wire is hardly visible under DSA radiography in operation, and in a 'tight' state, the positioning wire can be detected only through an extremely slight 'touch' of a far-away conveying system, so that not only is a great test on an operator, but also natural valve leaflets of a human body can be directly penetrated in a state of being unable to detect 'tight', and the patient is damaged.

(5) Releasing the main stent and withdrawing the delivery system. Corresponding to the description of "until the positioning wire 107 is in a tight state", the delivery system 200 is also in a limited state (see fig. 10 of document 1), then the loading sheath 202 is moved backward slowly by the handle 203, so that the lower bellmouth structure 101 of the main stent is released from the loading sheath 202 of the delivery system 200, the lower bellmouth structure 101 is automatically expanded to the maximum due to the shape memory property of the material of the aortic valve device 100, the human natural valve leaflet tissue 300 is expanded, at this time, the human natural valve leaflet tissue 300 is located between the lower bellmouth structure 101 and the positioning ring 103 of the aortic valve device 100 (see fig. 11 of document 1), the aortic valve device 100 is accurately positioned, the loading sheath 202 is moved backward continuously again by the handle 203 of the delivery system 200, the upper bellmouth structure 105 and the upper circular connecting claw 106 of the aortic valve device 100 are released from the loading sheath 202, the upper bellmouth structure 105 is automatically expanded to the maximum due to the shape memory property of the material of the aortic valve device 100, the human natural valve leaflet tissue 300 is attached to the vessel wall (see fig. 11), the upper circular connecting claw 106 is withdrawn from the delivery system 200, and finally the aortic valve device 100 is implanted into the system 200.

It is worth noting that the positioning of the main support has actually been completed in step (4), since it has been limited by the tight condition of the positioning wire, no longer being able to be shifted. In the step (5), the lower bell mouth of the main bracket is released, so that the final positioning effect is stably finished.

In the document CN105496607a, the stent body is a long stent, which has a certain shielding to the coronary artery, and the implantation depth is deeper, which is easy to cause heart conduction block.

The stent is a short stent, has small shielding to the coronary artery and shallow implantation depth, and is not easy to generate conduction block.

The foregoing describes preferred embodiments of the present invention, but is not intended to limit the invention thereto. Modifications and variations to the embodiments disclosed herein may be made by those skilled in the art without departing from the scope and spirit of the invention.

Claims (10)

1. The aortic valve is characterized by comprising a bracket body, a positioning ring and connecting wires, wherein the bracket body comprises a top connecting rod and a multi-layer hole type supporting structure, and the top connecting rod is fixedly arranged at the top of the proximal end of the multi-layer hole type supporting structure; the far end of the multi-layer hole type supporting structure is provided with a first layer hole type supporting structure, the first layer hole type supporting structure comprises a plurality of first layer supporting holes which are arranged along the circumferential direction of the bracket body, and the adjacent first layer supporting holes are fixedly connected together through a first node; the positioning ring consists of a plurality of connecting rods which are connected end to end in sequence, and the adjacent connecting rods are connected together through arc-shaped connecting sections; the arc-shaped connecting section is provided with a connecting hole; one end of the connecting wire is fixedly connected to the first node; the other end of the connecting wire is fixedly connected in the connecting hole; the length of the connecting wire is such that when the positioning ring reaches the sinus bottom of the native valve leaflet, the position of the bracket body connected with the positioning ring through the connecting wire also just reaches the position capable of perfectly clamping the native valve leaflet with the positioning ring.

2. The aortic valve according to claim 1, wherein adjacent connecting bars form a U-shape or V-shape therebetween.

3. The aortic valve according to claim 1, wherein the multi-layered hole pattern support structure comprises a first layer of hole pattern support structure, a second layer of hole pattern support structure, a third layer of hole pattern support structure, a fourth layer of hole pattern support structure, and a fifth layer of hole pattern support structure sequentially arranged from a distal end to a proximal end, wherein the third layer of hole pattern support structure comprises a plurality of third layer of support holes arranged along a circumferential direction of the stent body, and leaflet sewing ears and/or stent bars are disposed between adjacent third layer of support holes.

4. The aortic valve according to claim 1, wherein two connection holes are provided on each arcuate connection section.

5. The aortic valve according to claim 1, wherein a plurality of protruding nodes are provided on the connecting rod, the adjacent protruding nodes are suitable for winding the suture, and the protruding nodes are used for preventing the wound suture from being displaced or stacked due to friction or extrusion, and the wound suture is used for reducing direct contact between the positioning ring and the stent body and avoiding abrasion of the stent body due to friction between the positioning ring and the stent body.

6. The aortic valve according to claim 5, wherein a platinum iridium alloy wire is wound between adjacent raised nodes, a suture is wound around the platinum iridium alloy wire, and the platinum iridium alloy wire is used for visualization in surgery.

7. The aortic valve according to claim 1, wherein the distal end of the stent body has a flared structure to fit the natural physiological structure of the human body.

8. The aortic valve according to claim 1, wherein the positioning ring and the stent body are adapted to clamp native leaflets.

9. The aortic valve according to claim 1, wherein the stent body is made of nitinol.

10. The aortic valve according to any one of claims 1 to 9 wherein the connecting wires are connected to the positioning ring and the stent body in a configuration in which the knots are located on the inside and the outside remains smooth.

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