CN112155789A - Valve seat for preventing descending of interventional aortic valve - Google Patents

Abstract

The invention discloses a valve seat implanted through a catheter and used for preventing a prosthetic aortic valve implanted through the catheter from sliding downwards. The key points of the technical scheme are as follows: three interconnected semi-elliptical metal frame feet are arranged, the elliptical arc is downward, and the upper ends are mutually connected in series. Each seat foot connecting part is connected to a long limiting rod, the lower end of each rod is provided with a barb, and the upper end of each rod is provided with a locking point. The valve seat is made of a memory alloy material and can be compressed in a delivery system for implantation. When the aortic valve seat is used, the valve seat is implanted firstly, the three semi-elliptical metal frame seat feet are placed to three aortic valve sinuses, and the three metal rods at the joints extend downwards to the level of the aortic valve annulus through the valve orifice, so that the barbs are positioned below the aortic valve annulus. When the artificial aortic valve is implanted subsequently, the barb is used for hooking the valve frame of the artificial valve, so that the valve frame can be prevented from sliding downwards.

Description

Valve seat for preventing descending of interventional aortic valve

Technical Field

The invention relates to the technical field of medical instruments, in particular to a valve seat for preventing a prosthetic aortic valve implanted through a catheter from sliding downwards.

Background

Transcatheter artificial aortic valve implantation is a rapidly developing cardiac treatment technique in recent years, and provides treatment opportunities for many patients who cannot undergo traditional surgery, so that the patients can continue to live. However, currently all prosthetic aortic valves available for transcatheter implantation from the peripheral arterial (e.g., femoral) approach are approved only for patients with aortic stenosis. However, in the majority of patients with aortic insufficiency, the incidence of which is similar to that of aortic stenosis, there is still no suitable intervention valve via the peripheral arterial route. The only intervention valve which can be used for aortic insufficiency at present needs to be subjected to chest incision and implanted from the apical part of the heart. The reason for limiting the treatment of aortic insufficiency by implanting an artificial aortic valve through a peripheral artery at present is that the implanted aortic valve cannot be well fixed at the orifice of the aortic insufficiency, and the operation fails due to obvious gliding displacement.

The interventional aortic valve, as mentioned in patent application No. (CN201480022133.7) and other patents to the patentees for interventional aortic valves, is currently the only prosthetic interventional valve approved for aortic insufficiency, with anchoring structures. The anchoring structure is a component of the valve, and positioning and releasing of the valve are realized through a specific matching structure on the valve. This anchoring structure and the valve have some drawbacks: the whole system can not be recovered after the structure is released, and if the disease condition changes and the operation needs to be stopped, the whole system can be taken out through a conventional open operation, so that the wound is large. The presence of the anchoring structure, which significantly increases the complexity of the valve delivery system, requires a larger approach for implantation (e.g., a chest incision). The anchoring structure needs to be matched with a corresponding structure on the valve, and cannot be used for other artificial valves for intervention.

How to solve the problem of the gliding displacement of the artificial aortic valve implanted by the peripheral artery approach becomes the difficulty of the current transcatheter artificial aortic valve implantation. At present, no technology and apparatus for solving the problem of the gliding of the current artificial aortic valve through a peripheral arterial catheter are available.

The present invention aims to provide a transcatheter implanted valve seat for preventing the artificial aortic valve from sliding down, thereby enabling patients with aortic insufficiency who cannot tolerate conventional operations to have an opportunity to perform minimally invasive transcatheter artificial aortic valve implantation via the peripheral arterial approach.

Disclosure of Invention

There is no approved device for treating aortic insufficiency implantable by the peripheral arterial approach, and the object of the present invention is to provide a transcatheter implanted valve seat capable of preventing the inferior sliding displacement of the currently marketed artificial aortic valve implanted by the peripheral artery. Enabling interventional prosthetic valves that would otherwise be usable only for aortic stenosis to be equally useful for treating aortic insufficiency.

The valve seat comprises three semi-elliptical metal seat legs which are mutually connected in series, and three limiting rods which are fixed at the joints of the seat legs. The lower end of the limiting rod is provided with a barb, and the upper end of the limiting rod is provided with a locking point. When the aortic valve is implanted, the three seat legs are placed at the sinus bottoms of the three aortic valves, the three limiting rods extend downwards from the orifice to the position below the valve, and the end barbs are unfolded inwards. The limiting rod is upward in an arc shape with the middle part protruding outwards. The function of the original valve is not affected by only implanting the device, and the valve seat can be recycled and adjusted. When the valve is subsequently implanted into the transcatheter artificial aortic valve which is on the market at present, the valve can be pulled by the barb at the lower end of the valve seat limiting rod and can not slide down, so that the position of the implanted valve can be ensured to be accurate, and the success of implantation can be ensured.

The innovation points of the invention are as follows: the invention discloses a valve seat which is implanted through a catheter and is used for preventing a prosthetic aortic valve implanted through the catheter from sliding downwards and shifting, and fills the blank of the technology. The oval seat leg can adapt to the form of the sinus of the autologous aortic valve, the valve seat does not influence the function of the original valve, and meanwhile, the seat leg can obtain enough supporting force at the sinus bottom. The design of the restraining bar barb can be used to hook and pull all currently marketed transcatheter implanted prosthetic aortic valves. The arc design of the upper section of the limiting rod can be compatible with the shapes of various interventional artificial valves on the market at present, and the blood flow is not influenced. The design of the upper end locking point of the limiting rod can ensure the controllability of the release of the valve seat and can also recover the valve seat when the operation needs to be stopped.

From the above description of the invention, the invention aims to solve the problem that the artificial valve slides down and shifts when the artificial aortic valve is implanted by a catheter through a peripheral artery, so that the catheter artificial aortic valve implantation operation can be used for treating a large number of patients with aortic valve insufficiency which cannot tolerate the conventional operation, and the patients can obtain the treatment opportunity.

Drawings

FIG. 1 is a front view of a petal seat

FIG. 2 is a front oblique upper view of the petal seat

FIG. 3 is a top view of the petal seat

FIG. 4 is a schematic view showing the structure of the aortic root (5) in the vicinity of the aortic valve

FIG. 5 is a schematic view of a valve seat mounted in a delivery sheath and delivered through a peripheral artery to the aortic orifice

FIG. 6 is a schematic view of the foot resting on the aortic valve, with the delivery catheter sheath removed, the foot released, and the locking point held in a locked position

FIG. 7 is a cross-sectional view of the locking point and the underside of the locking point with the flap seat installed in the delivery sheath

FIG. 8 is a schematic view of the foot placed in the valve sinus after the seat is fully released

FIG. 9 is a schematic view of a common transcatheter implanted prosthetic aortic valve (valve in released state)

Fig. 10 is an overall view of the transcatheter prosthetic aortic valve after placement of the valve seat and implantation.

The reference numerals in the figures denote: 1. seat legs (1 a, 1b, 1c, three seat legs are respectively shown); 1d, marking points on one of the seat legs; 2. restriction levers (2 a, 2b, 2c, three restriction levers are respectively indicated); 3. barbs (3 a, 3b, 3c, three barbs each shown) that bound the lower end of the stem; 4. locking points (4 a, 4b, 4c, three for each) at the upper end of the restraining bar; 5. aortic root, aortic valve sinus schematic; 5a, aortic sinus; 5b, aortic valve leaflets; 5c, coronary artery; 6. a morphological schematic diagram after release of a common artificial aortic valve for intervention. 7. A catheter sheath for assisting in implanting the valve seat; 8. an inner core of the catheter sheath for assisting implantation of the valve seat; 9. the locking buckle part of the catheter sheath inner core for assisting the implantation of the valve seat.

Detailed Description

Fig. 1-10 illustrate the structure and manner of use of the valve seat of the present invention.

Figure 8 is a schematic view of the valve seat after implantation to a target location. A transcatheter implanted valve seat for preventing a transcatheter implanted prosthetic aortic valve from sliding down is shown. The valve seat comprises three semi-elliptical metal seat legs (1) which are mutually connected in series, and three limiting rods (2) which are fixed at the joints of the seat legs, wherein the lower end of each limiting rod is provided with a barb (3), and the upper end of each limiting rod is provided with a locking point (4); the seat foot is used for positioning to the bottom of the aortic valve sinus and obtaining the support of the bottom of the aortic valve sinus to avoid the valve seat from sliding downwards; the barb is used for hooking the subsequently implanted artificial aortic valve and preventing the artificial aortic valve from sliding downwards; the locking point is used for control when the valve seat is implanted and capture when recovery is needed. The seat legs (1) are three semi-elliptical metal frames, the elliptical edge rings are downward and slightly angled outwards, and the upper ends of the edge wires of the metal frames are connected in series to form a ring with three elliptical seat legs. The depth of the semiellipse is 1-2.5 cm, and the width is 1.5-3 cm. One oval seat leg (1) of the seat legs (1) is provided with a mark point (1 d) which is not transparent to X rays and used for judging the direction of the seat leg during implantation. The limiting rod (2) is a vertical rod which is fixed at the joint between the three seat legs in the vertical direction and is 4-7 cm long; the downward part of the limiting rod at the fixing point of the seat leg is vertical to the plane where the bottoms of the three seat legs are located, and the lower end of the rod exceeds the plane where the bottoms of the three seat legs are located by 4-10 mm; the part of the limiting rod above the fixing point of the seat foot is in an arc shape with a convex middle part and an inward bent tail end. The limiting rods (2) are arranged in such a way that the lengths of the three limiting rods extending into the valve can be set to be different lengths respectively according to the difference of implantation angles in actual use; in addition, according to actual use conditions, the downward parts of the three limiting rods at the seat leg fixing points can not be completely vertical to the planes of the three seat legs, and different adduction angles can be arranged. The limiting rod (2) is provided with a barb (3) at the tail end of the lower end, and the length of the hook is 2-6 mm. The direction of the hook is opposite to the center of the ring enclosed by the petal seats. The end of the upper end of the limiting rod is provided with a locking point (4) for locking before the valve seat is released, so that the valve seat is convenient to recover and reposition during implantation, and the implantation position is convenient to adjust. The valve seat is made of a shape memory alloy material similar to a valve frame or an artificial great vessel stent of a commercially available artificial aortic valve, and has good biological stability and elasticity. The valve seat can be compressed in the delivery sheath, and is convenient to implant through a peripheral blood vessel. The implantation delivery system of the valve seat can use a delivery system similar to a common delivery system which is used for implanting the artificial aortic valve through a peripheral artery route and is on the market, and the use is convenient.

When the valve seat is used, the three seat feet (1) are correspondingly placed at the bottoms of three aortic valve sinuses, and the lower ends of the three limiting rods (2) extend downwards to the lower part of an aortic valve orifice, so that the three barbs (3) are positioned under the aortic valve annulus and used for hooking a subsequently implanted artificial aortic valve. The locking point (4) is used for controlling the release and the recovery of the valve seat. The valve seat may be implanted by a delivery system similar to a conventional prosthetic aortic valve.

Figures 1 to 10 show the structure of the petal seat and the process of use thereof

Fig. 1 is a front view of the petal seat, and it can be seen that three seat legs (1) are connected end to end, limiting rods (2) are fixed at three joints, a barb (3) is arranged at the lower end of each limiting rod, and a locking point (4) is arranged at the upper end of each limiting rod. One seat leg (1) is provided with a marking point (1 d).

FIG. 2 is a view of the valve seat from the front to the top, showing three legs (1 a, 1b, 1 c), a mark (1 d) on the leg (1 a), three restraining bars (2 a, 2b, 2 c) fixed at the joint of the legs, barbs (3 a, 3b, 3 c) at the lower end of the three restraining bars and locking points (4 a, 4b, 4 c) at the upper end of the three restraining bars

Fig. 3 is a top view of the valve seat from top to bottom, showing three seat legs (1) connected in series, three restraining rods (2) connected to the connection points of the seat legs, locking points (4) at the upper ends of the restraining rods, and barbs (3) at the lower ends of the restraining rods. The marking point (1 d) is visible on one seat leg.

Fig. 4 is a schematic diagram of the aortic root (5) structure in the vicinity of the aortic valve. The aortic sinus (5 a), aortic valve (5 b), coronary artery (5 c) are visible. The aortic valve (5 b) has a root attachment edge that is the aortic annulus (5 d). The position where the aortic valve (5 b) is opened and closed is the aortic valve orifice (5 e).

Figure 5 is a schematic view of the valve seat in a delivery sheath delivered through a peripheral artery to the aortic valve orifice. The seat leg (1) and the barb (3) which are in a compressed state are retracted in the conveying sheath (7), and the limiting rods are in a state of being close to each other. The middle of the valve seat passes through an auxiliary input catheter sheath inner core (8). The locking point (4) at the upper end of the valve seat is arranged in a locking buckle (9) of the catheter sheath inner core of the input system.

Figure 6 is a schematic view of the foot resting on the aortic valve, the delivery catheter sheath withdrawn, the foot released, and the locking point held in a locked position. The barb (3) positioned below the aortic valve orifice and the seat leg (1) positioned above the aortic valve leaflet can be seen, and the mark point (1 d) used for judging the direction is arranged on the seat leg. The outer sheath (7) of the delivery system retreats to the lower edge of the locking buckle, and the locking point (4) is still arranged in the locking buckle (9). The catheter sheath inner core (8) is positioned in the center of the valve seat.

Fig. 7 is a cross-sectional view of the locking point and the underside of the locking point when the flap is seated within the delivery sheath. The locking structure is arranged in the sheath (7) of the conveying system, the locking buckle (9) is mostly solid, three grooves are provided for placing three locking points (4 a, 4b and 4 c), and small thread guide grooves are arranged below the grooves for accommodating the limiting rods (2 a, 2b and 2 c) to pass through. The locking point of the petal seat is locked by the groove.

Fig. 8 is a schematic view of the valve seat fully released after the seat foot is placed in the valve sinus. It can be seen that the seat foot (1) is arranged at the bottom of the aortic sinus (5 c), the lower section of the limiting rod extends to the position below the aortic valve orifice, and the three barbs are positioned below the aortic valve orifice.

FIG. 9 is a schematic view of a common transcatheter implanted prosthetic aortic valve (valve in released state)

Fig. 10 is an overall view of the transcatheter prosthetic aortic valve after placement of the valve seat and implantation. The seat leg (1) is located at the bottom of the aortic sinus (5 a), the aortic valve leaflet (5 b) is located between the seat leg (1) and the artificial aortic valve (6), and the barb (3) is located at the lower edge of the valve frame of the artificial aortic valve (6) and hooks the valve frame to prevent the artificial aortic valve from sliding downwards.

When the valve seat is used, the valve seat is compressed and collected in the catheter sheath, and the locking point at the upper end is arranged in the locking buckle of the inner core of the delivery catheter sheath. Under the guidance of a conventional guide wire, the aortic sinus guiding device is sent to the position above an aortic valve orifice through a peripheral artery (such as a femoral artery), the outer sheath of the conveying device is withdrawn, the lower half part of a valve seat is released, the three seat legs are unfolded, the three seat legs point to three aortic sinus under the ultrasonic and X-ray observation, and the whole device is sent downwards until the seat legs reach the bottom of the aortic sinus. And continuously withdrawing the sheath until the locking buckle part is separated from the sheath, and completely releasing the valve seat.

After the valve seat is implanted, the transcatheter artificial aortic valve is implanted according to the conventional method. When the artificial valve slides down, the lower end of the artificial valve frame can be hooked by the barb at the lower end of the valve seat limiting rod, so that the artificial valve cannot slide down continuously, the position of the artificial valve is kept stable, and the success of the operation is ensured.

The invention aims to provide a valve seat implanted through a catheter, which is used for solving the problem that an artificial aortic valve implanted through a catheter by a peripheral arterial approach slides down and shifts, so that the artificial aortic valve implanted through a catheter by a peripheral arterial approach can be used for treating a great number of patients with aortic valve insufficiency which cannot tolerate a conventional operation, and the patients can obtain the opportunity of treatment.

The foregoing is only a preferred embodiment of the present invention and is not intended to limit the present invention in any manner. Although the present invention has been described with reference to the preferred embodiments, it is not intended to be limited thereto. Those skilled in the art can make numerous possible variations and modifications to the disclosed embodiments, or modify equivalent embodiments, without departing from the scope of the invention, using the teachings disclosed above. For example, a circular connecting frame is added among the three limiting rods. Therefore, any simple modification, equivalent change and modification made to the above embodiments according to the technical spirit of the present invention should fall within the protection scope of the technical scheme of the present invention, unless the technical spirit of the present invention departs from the content of the technical scheme of the present invention.

Claims (9)

1. A valve seat implanted through a catheter and used for preventing a prosthetic aortic valve implanted through the catheter from sliding downwards comprises three semi-elliptical metal seat feet (1) which are connected in series, and three limiting rods (2) fixed at the joints of the seat feet, wherein the lower end of each limiting rod is provided with a barb (3), and the upper end of each limiting rod is provided with a locking point (4); the seat foot is used for positioning to the bottom of the aortic valve sinus and obtaining the support of the bottom of the aortic valve sinus to avoid the valve seat from sliding downwards; the barb is used for hooking the subsequently implanted artificial aortic valve and preventing the artificial aortic valve from sliding downwards; the locking point is used for control when the valve seat is implanted and capture when recovery is needed.

2. The valve seat implanted through the catheter for preventing the artificial aortic valve implanted through the catheter from sliding down as claimed in claim 1, wherein the seat foot (1) is three semi-elliptical metal frames, the edge circle of the ellipse is downward and slightly angled to the outside, the upper ends of the edge lines of the metal frames are connected in series to form a circle with three elliptical seat feet, the depth of the semi-ellipse is 1-2.5 cm, and the width is 1.5-3 cm.

3. The valve seat implanted through the catheter and used for preventing the artificial aortic valve implanted through the catheter from sliding down as claimed in claim 1, wherein the seat foot (1), wherein an oval seat foot is provided with X-ray-proof mark points (1 d) for judging the direction of the seat foot when in implantation.

4. The valve seat implanted through the catheter and used for preventing the artificial aortic valve implanted through the catheter from sliding down as claimed in claim 1, wherein the limiting rod (2) is a vertical rod fixed at the joint between the three seat legs in the up-down direction and has a length of 4-7 cm; the downward part of the limiting rod at the fixing point of the seat leg is vertical to the plane where the bottoms of the three seat legs are located, and the lower end of the rod exceeds the plane where the bottoms of the three seat legs are located by 4-10 mm; the part of the limiting rod above the fixing point of the seat foot is in an arc shape with a convex middle part and an inward bent tail end.

5. The valve seat implanted through the catheter and used for preventing the artificial aortic valve implanted through the catheter from sliding down as claimed in claim 4, wherein the limiting rods (2) are respectively set to different lengths according to the difference of implantation angles in actual use; in addition, according to actual use conditions, the downward parts of the three limiting rods at the seat leg fixing points can not be completely vertical to the planes of the three seat legs, and different adduction angles can be arranged.

6. The transcatheter implanted valve seat for preventing the transcatheter implanted artificial aortic valve from sliding down as claimed in claim 1, wherein the limiting rod (2) has a barb (3) at the end of its lower end, the length of the hook is 2-6 mm, and the direction of the hook is toward the center of the circle enclosed by the valve seat.

7. The transcatheter valve seat for preventing the gliding of the transcatheter artificial aortic valve as claimed in claim 1, wherein the limiting rod has a locking point (4) at its upper end for locking the valve seat before release, facilitating the recovery and repositioning during implantation and facilitating the adjustment of the implantation position.

8. The valve seat implanted through the catheter for preventing the artificial aortic valve implanted through the catheter from sliding down as claimed in claim 1, wherein the valve seat is made of a shape memory alloy material similar to a valve frame or an artificial great vessel stent of an artificial aortic valve on the market, has good biological stability and good elasticity, and can be compressed in a delivery sheath for being implanted through a peripheral vascular approach.

9. The valve seat implanted by the catheter for preventing the artificial aortic valve implanted by the catheter from sliding down as claimed in claim 1, wherein the implanted delivery system can be similar to the delivery system implanted by the common peripheral arterial approach on the market, and is convenient to use.

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