A self-expanding biological valve

Abstract

The application discloses a self-expanding biological valve, which comprises a fixing support, an inflow end support structure, an outflow end support structure and a silica gel suture ring. The fixing support comprises a stretching part which is disconnected after being subjected to an expansion force, and then the valve is automatically expanded at a predetermined position. In the expanded state, the inflow end support structure and the outflow end support structure are outwardly extended in the radial direction relative to the fixing support, and are used for supporting the valve at the predetermined position, continuously exerting outward and / or downward force on the surrounding tissue, and ensuring reliable fixation of the valve. The valve of the application can be used for valve replacement without complicated suture, reduces the operation time, and reduces the risk of postoperative complications. The ingenious design of the valve can realize quick release and reliable fixation of the valve support.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of medical devices, in particular to a self-expanding biological valve composed of nickel-titanium memory alloy, biological tissue and other materials. It is implanted by surgical method and is suitable for replacement of diseased valve. It can be applied to aortic valve, pulmonary valve, mitral valve and tricuspid valve. BACKGROUND

[0002] Heart valve is damaged by various pathogenic factors or congenital malformation, resulting in one or more valve anatomical structure and function abnormalities, which are manifested as valve orifice stenosis and / or insufficiency. Mainly involving mitral valve and aortic valve (tricuspid valve and pulmonary valve are less involved), which are manifested as mitral stenosis (MS), mitral insufficiency (MR), aortic stenosis (AS), aortic insufficiency (AR) and combined valve disease.

[0003] In the prior art, valve replacement by surgical operation currently tends to implement minimally invasive, small incision surgical operation to reduce the damage to the patient and accelerate the recovery speed. Especially when the original valve calcification cannot be removed and the anatomical position is not well exposed, the traditional surgical method has the problem that the valve is difficult to suture. Moreover, if the problem of perivalvular leakage is found during the operation and needs to be replaced again, the original suture needs to be carefully removed, which not only increases the operation time, but also increases the complication rate after re-suturing due to the damage of the valve ring caused by knotting.

[0004] In recent years, transcatheter valve implantation is more and more widely used in the treatment of valvular disease, but the valve is difficult to accurately position during implantation, which easily leads to inaccurate implantation position of the valve; for elderly patients with severe calcification, the original calcification is not removed, which makes the valve and the valve ring difficult to completely match, and perivalvular leakage is easy to occur; in addition, displacement of the stent implantation is also easy to occur, which will affect the long-term prognosis of the patient.

[0005] Therefore, a self-expanding biological valve is expected, which is simple to remove and does not cause mechanical damage to the valve ring. At the same time, the self-expanding biological valve has lower requirements for surgical operation, is safe to implant, is convenient for minimally invasive surgery, and is also convenient for young heart surgeons to master. The self-expanding biological valve implantation technology is feasible and safe, which can significantly benefit the hemodynamics, significantly improve the clinical symptoms, and shorten the blood flow blocking time and extracorporeal circulation time, so as to effectively reduce the mortality and recurrence rate, and has wide indications and application prospect. SUMMARY

[0006] Therefore, the object of the present invention is to provide a self-expanding biological valve. Through its unique design, valve replacement can be carried out without complex suturing, reducing the extracorporeal circulation time, lowering the incidence of complications in important organs such as the heart, brain, liver, and kidneys after surgery, and also avoiding potential damage to, for example, the aortic root caused by surgical operations such as suture knotting.

[0007] The present invention is achieved through the following technical solutions:

[0008] The present invention provides a self-expanding biological valve, comprising a fixing stent, an inflow end support structure, an outflow end support structure, and a silicone suture ring; the fixing stent includes a stretching part, and three stretching parts are provided, respectively located at the lower edge positions of the three leaflet junctions of the fixing stent; the inflow end support structure and the outflow end support structure are arranged on the fixing stent, and in the deployed state, the inflow end support structure and the outflow end support structure extend outward relative to the fixing stent in the radial direction, for supporting the valve at a predetermined position and continuously applying an outward and / or downward force to the surrounding tissues to ensure reliable fixation of the valve; the silicone suture ring is arranged at the annulus plane position on the fixing stent, and the valve is sutured to the surrounding human tissues through the silicone suture ring for three-point positioning to ensure that the three leaflets in the valve are at appropriate positions in the annulus plane.

[0009] For the valve according to the present invention, the inflow end support structure and the outflow end support structure are support buttons or corollas.

[0010] For the valve according to the present invention, the support button structure is made of a nickel-titanium alloy material and has petal-shaped protrusions extending outward in the deployed state; the corolla consists of a uniformly distributed reticular structure, the reticular structure is made of a nickel-titanium alloy material, and its outside is wrapped with a skirt made of a polymer material. In the deployed state, its diameter is larger than the diameter of the annulus to prevent valve displacement.

[0011] For the valve according to the present invention, the stretching part has a structure with a cross-sectional area smaller than that of other parts of the fixing stent. During use, it is broken by means of a radially expanding force applied from the outside. After the stretching part is disconnected, the diameter of the fixing stent can become larger and expand outward.

[0012] For the valve according to the present invention, the stretching part is in a "ji" shape, and its expected disconnection position is at its bent part.

[0013] For the valve according to the present invention, the number of protrusions of the support button is 3 or more than 3, preferably a multiple of 3, and is uniformly distributed on the circumference of the fixing stent.

[0014] For the valve according to the present invention, the fixing stent is made of a metal or a polymer material.

[0015] According to the valve of the present invention, the inflow end support structure and the outflow end support structure are integrally formed.

[0016] According to the valve of the present invention, when used in a valve with a smaller inflow diameter and a larger outflow diameter, such as an aortic valve, the inflow support structure is a corolla and the outflow support structure is a support buckle.

[0017] According to the valve of the present invention, when used in a valve with a larger inflow diameter and a smaller outflow diameter, such as a tricuspid valve, the inflow support structure is a support buckle and the outflow support structure is a corolla.

[0018] According to the valve of the present invention, when used in a valve with both a small inflow diameter and a small outflow diameter, such as a pulmonary valve, both the inflow support structure and the outflow support structure are corollas.

[0019] According to the valve of the present invention, when used in a valve with both a large inflow diameter and a large outflow diameter, such as a mitral valve, both the inflow support structure and the outflow support structure are support buckles.

[0020] The beneficial effects of this invention are:

[0021] The advantages of this invention are that valve replacement can be performed without complex sutures, reducing surgical time and the risk of postoperative complications. Its ingenious design enables both rapid release and reliable fixation of the valve stent. If intraoperative examination reveals problems such as paravalvular leakage requiring replacement, the self-expanding bioprosthetic valve is easy to remove without mechanical damage to the valve annulus, requiring less skill in surgical manipulation, facilitating minimally invasive surgery, and making it easier for young cardiac surgeons to master. The stent breakage and stretching point is located at the junction of the fixed stent leaflet and is completely covered by a polymer skirt, which has been experimentally verified to be very safe and reliable. Attached Figure Description

[0022] Figure 1 This is a schematic diagram of an embodiment of the self-expanding bioprosthetic valve of the present invention used for aortic valve replacement;

[0023] Figure 2 This is a partially enlarged view of the stretching portion of the self-expanding bioprosthetic valve fixation stent according to an embodiment of the present invention;

[0024] Figure 3 This is a schematic diagram of a self-expanding bioprosthetic valve implanted in the aorta according to an embodiment of the present invention;

[0025] Figure 4 This is a top view of the self-expanding bioprosthetic valve according to an embodiment of the present invention;

[0026] Figure 5 Schematic diagram of the single-layer fixed stent structure of the self-expanding biological valve according to an embodiment of the present invention;

[0027] Figure 6 Schematic diagram of the double-layer fixed stent structure of the self-expanding biological valve according to an embodiment of the present invention;

[0028] Figure 7 Schematic diagram of the outer stent of the double-layer fixed stent of the self-expanding biological valve according to an embodiment of the present invention;

[0029] Figure 8 Schematic diagram of the inner stent of the double-layer fixed stent of the self-expanding biological valve according to an embodiment of the present invention;

[0030] Figure 9 Schematic diagram of an embodiment showing the use of the self-expanding biological valve of the present invention for pulmonary valve replacement;

[0031] Figure 10 Schematic diagram of an embodiment showing the use of the self-expanding biological valve of the present invention for mitral valve replacement;

[0032] Figure 11 Schematic diagram of an embodiment showing the use of the self-expanding biological valve of the present invention for tricuspid valve replacement. Detailed implementation manners

[0033] The present invention will be further described below in conjunction with specific embodiments. It should be understood that the embodiments are only used to illustrate the present invention and not to limit the protection scope of the present invention. In addition, it should be understood that after reading the content disclosed in the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms also fall within the protection scope defined by the present invention.

[0034] In this embodiment, the self-expanding biological valve for aortic valve replacement is taken as an example, and the following specific description is made for the self-expanding biological valve of the present invention. As Figure 1 shown, the self-expanding biological valve includes a fixed stent 1, an outflow end support structure 3, a silicone suture ring 4 and an inflow end support structure 5. The fixed stent 1 is made of a metal or a polymer material, such as PETG and ABS materials. Three stretching parts 2 are provided on the fixed stent 1 (see Figure 2 ), which are respectively located at the lower edge positions of the junctions of the three leaflets of the fixed stent 1 (not shown in the figure). The stretching part 2 is in a "ji" shape, and the cross-sectional area of this part is smaller than that of other parts of the fixed stent, so the strength is lower and it is easy to break when subjected to a radially outward expansion force, especially its bent part is more likely to break.

[0035] The fixed stent 1 can adopt various structures. In this embodiment, two schemes of a single-layer stent structure and a double-layer stent structure are respectively adopted. Figure 5A scheme for a single-layer support structure is shown; Figure 6 A scheme with a double-layer support structure is shown. The outer support 11 is a short support structure (see...). Figure 7 It is made of metal, and the inner support 12 is a long support structure (see...). Figure 8 ), made of polymer material, the two are fixed together by stitching to form a fixed support 1.

[0036] The outflow end support structure 3 adopts a support buckle structure. The outflow end support structure 3 (i.e., the support buckle) is set on the fixed bracket 1 and is located at the outflow end of the valve. In the unfolded state, the support buckle extends outward relative to the fixed bracket 1 in the radial direction (e.g., Figure 1 and Figure 4 As shown, the valve is shaped like an open petal and is used to support the valve within the aortic sinus, continuously applying outward and downward forces to the surrounding tissues to ensure reliable valve fixation. The support buckle includes three petal-shaped protrusions, and the number of these protrusions can also be more than three, preferably a multiple of 3, evenly distributed on the circumference of the fixation bracket 1, all made of nickel-titanium alloy.

[0037] The silicone suture ring 4 is positioned on the valve annulus plane of the fixed bracket. The artificial valve is sutured to the surrounding tissue at three points via the silicone suture ring, thereby determining the accurate position of the three leaflets in the valve annulus plane. The inflow support structure 5 adopts a corolla structure, which is wrapped with a skirt made of polymer material (not shown in the figure). In the unfolded state, its diameter is larger than the diameter of the valve annulus, exerting an outward force on the surrounding tissue to prevent valve displacement (e.g., Figure 3 (As shown). The corolla 5 and the support buckle 3 are manufactured using a one-piece molding and integral cutting method. When sewing the skirt hem, the corolla 5 and the support buckle 3 are connected to the fixing bracket 1 at the same time.

[0038] Before implantation, the valve is held in a contracted state by tightening the support buckle 3 and corolla 5 with binding sutures. When the valve is implanted into the predetermined position in the aorta, the binding sutures are removed, and the support buckle 3 and corolla 5 are naturally released. Due to the excellent elasticity of the nickel-titanium alloy material, the support buckle 3 and corolla 5 can quickly release to the desired shape. Figure 3 As shown, the force exerted by the support buckle 3 and the corolla 5 on the tissue surrounding the valve fixes the valve in the desired position, preventing it from slipping. Then, an expansion device, such as a high-pressure balloon device, is inserted into the valve stent and applied radial expansion force. The tension part 2 on the fixation stent 1 is broken by the expansion force. As each tension part 2 breaks, the fixation stent 1 expands rapidly in the radial direction, closely fitting with the surrounding vascular tissue, ensuring reliable fixation of the valve.

[0039] Figure 9An embodiment of the self-expanding bioprosthetic valve of the present invention for pulmonary valve replacement is shown. In this embodiment, since both the inflow end diameter and the outflow end diameter are relatively small, both the inflow end support structure 5 and the outflow end support structure 3 are corollas.

[0040] Figure 10 An embodiment of the self-expanding bioprosthetic valve of the present invention for mitral valve replacement is shown. In this embodiment, since both the inflow and outflow diameters are relatively large, the inflow support structure 5 and the outflow support structure 3 are both support buckles.

[0041] Figure 11 An embodiment of the self-expanding bioprosthetic valve of the present invention is shown for tricuspid valve replacement. In this embodiment, since the inflow diameter is larger and the outflow diameter is smaller, the inflow support structure 5 is a support buckle and the outflow support structure 3 is a corolla.

Claims

1. A self-expanding bioprosthetic valve, characterized in that, It includes a fixed stent, an inflow end support structure, an outflow end support structure and a silicone suture ring; the fixed stent includes a stretching part, and three stretching parts are provided, which are respectively located at the lower edge positions of the three leaflet junctions of the fixed stent; the inflow end support structure and the outflow end support structure are arranged on the fixed stent. In the deployed state, the inflow end support structure and the outflow end support structure protrude outward relative to the fixed stent in the radial direction, and are used to support the valve at a predetermined position, continuously exert an outward and / or downward force on the surrounding tissue to ensure the reliable fixation of the valve; the silicone suture ring is arranged at the annulus plane position on the fixed stent, and the valve is three-point positioned and sutured to the surrounding human tissue through the silicone suture ring to ensure that the three leaflets in the valve are in the appropriate positions in the annulus plane; the stretching part has a structure with a cross-sectional area smaller than that of other parts of the fixed stent. During use, it is broken by a radially expanding force applied from the outside. After the stretching part is disconnected, the diameter of the fixed stent can become larger and expand outward, and the stretching part is in a "U" shape, and its expected disconnection position is at its bent part; the inflow end support structure and the outflow end support structure are manufactured by an integral molding and overall cutting method.

2. The self-expanding bioprosthetic valve according to claim 1, characterized in that, The inflow end support structure and the outflow end support structure are support buttons or corollas; the support button structure is made of nickel-titanium alloy material and has petal-shaped protrusions that protrude outward in the deployed state; the corolla consists of a uniformly distributed mesh structure made of nickel-titanium alloy material, and its outside is wrapped with a skirt made of polymer material. In the deployed state, its diameter is larger than the diameter of the annulus to prevent the valve from shifting.

3. The self-expanding bioprosthetic valve according to claim 2, characterized in that, The number of protrusions of the support button is 3 or more than 3, and they are evenly distributed on the circumference of the fixed stent.

4. The self-expanding bioprosthetic valve according to claim 2, characterized in that, The number of protrusions of the support button is a multiple of 3.

5. The self-expanding bioprosthetic valve according to claim 1, characterized in that, The fixed stent is made of metal or polymer material.

6. The self-expanding bioprosthetic valve according to any one of claims 2-5, characterized in that, When used for a valve with a smaller inflow end diameter and a larger outflow end diameter, the inflow end support structure is a corolla, and the outflow end support structure is a support button.

7. The self-expanding bioprosthetic valve according to any one of claims 2-5, characterized in that, When used for a valve with a larger inflow end diameter and a smaller outflow end diameter, the inflow end support structure is a support button, and the outflow end support structure is a corolla.

8. The self-expanding bioprosthetic valve according to any one of claims 2-5, characterized in that, When used for a valve with both a smaller inflow end diameter and a smaller outflow end diameter, both the inflow end support structure and the outflow end support structure are corollas.

9. The self-expanding bioprosthetic valve according to any one of claims 2-5, characterized in that, When used for a valve with both a larger inflow end diameter and a larger outflow end diameter, both the inflow end support structure and the outflow end support structure are support buttons.

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