Vena cava interventional valve

Abstract

The utility model relates to the field of interventional therapy, and discloses a vena cava interventional valve. The vena cava interventional valve comprises a body support, the body support comprises an upper cone part, a barrel part and a lower cone part, and the upper cone part and the lower cone part are arranged at the two ends of the barrel part respectively; the fixing piece is arranged at the joint of the upper cone part and the barrel part; the covering film is arranged on the outer side of the body stent; and the artificial valve leaflet is arranged in the barrel part of the body bracket. The conveying size of an existing inferior vena cava filter is small and is only 6F, and the inferior vena cava filter is improved on the basis of the basic structure of the inferior vena cava filter, so that the inferior vena cava filter has the same small conveying size and fixing efficiency; by means of the fixing piece, positioning can be accurately and easily achieved in the valvular operation, and the pressing difficulty of the surgical operation is reduced; and the valve can be completely recovered before being completely released, so that the safety of the operation is improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of interventional therapy, more particularly, to an interventional vena cava valve. BACKGROUND

[0002] Tricuspid valve is a common heart valve disease in clinic, with high incidence and great impact on patient health. The current main treatment methods include drug therapy and surgical treatment. However, drug therapy can only improve the symptoms of edema in patients, and has no obvious effect on patients in the late stage. Surgical treatment has great trauma and high surgical risk, and the perioperative mortality rate can reach 10%, which leads to the fact that few patients receive surgical treatment in current practice. Transcatheter tricuspid valve intervention is a new treatment method for tricuspid regurgitation, which has gradually attracted clinical attention and promotion, including transcatheter tricuspid valve edge-to-edge repair, transcatheter tricuspid valve annuloplasty and transcatheter tricuspid valve replacement.

[0003] Among them, transcatheter tricuspid valve replacement is more complete in eliminating regurgitation and more accurate in curative effect compared with transcatheter tricuspid valve repair, and is a very promising development direction, including transcatheter orthotopic tricuspid valve replacement and ectopic tricuspid valve replacement. Ectopic tricuspid valve replacement is to implant an interventional valve in each of the superior and inferior vena cava, so as to prevent the regurgitant blood from entering the superior and inferior vena cava, thereby reducing the symptoms of body circulation congestion. Compared with orthotopic tricuspid valve replacement, ectopic tricuspid valve replacement has the advantages of simpler operation (without capturing tricuspid valve leaflets) and higher safety (without entering the heart to interfere with the heart).

[0004] However, the superior and inferior vena cava of patients with tricuspid regurgitation is significantly enlarged, and the valve delivery size according to the current conventional valve design is often large (such as TriCare valve with 28F), which causes great damage to the blood vessels and great support to the vena cava, resulting in discomfort of the patient and still complex operation. A vena cava interventional valve with smaller delivery system and simpler operation is needed in clinic. SUMMARY

[0005] The application aims to provide a vena cava interventional valve with smaller delivery system and simpler operation.

[0006] In order to achieve the above application purpose, the application adopts the following technical solutions:

[0007] The application provides a vena cava interventional valve with small delivery system and simple operation, which comprises:

[0008] The body support comprises an upper cone part, a barrel part and a lower cone part, and the upper cone part and the lower cone part are respectively arranged at two ends of the barrel part;

[0009] The fixing member is arranged at the connection between the upper cone part and the barrel part;

[0010] A film is arranged outside the body support; and

[0011] An artificial valve leaflet is arranged in the barrel part of the body support.

[0012] Further, the fixing member is expanded upward and outward at the joint of the upper cone part and the barrel part, and the tail end is folded upward and inward.

[0013] Further, the barrel part is a barrel-shaped hollow support composed of diamond-shaped cells and / or hexagonal cells.

[0014] Further, the upper cone part is a cone structure formed above the barrel part by extending all the longitudinal lines of the barrel part upward and inward.

[0015] Further, the lower cone part is a cone structure formed below the barrel part by extending all the longitudinal lines of the barrel part downward and inward.

[0016] Further, the barrel part is provided with a barb structure outside.

[0017] Further, the film is a polymer film or a biological film.

[0018] Further, the artificial valve leaflet is a three-leaflet valve.

[0019] In summary, the present application has the following beneficial effects:

[0020] The delivery size of the inferior vena cava filter is currently small, only 6F, and the present application is improved on the basis of the basic structure, so it has the same small delivery size and fixing performance; the fixing member enables the valve to be accurately and simply positioned during surgery, reducing the difficulty of surgical operation; the valve can be completely recovered during complete release, improving the safety of surgery. BRIEF DESCRIPTION OF DRAWINGS

[0021] Figure 1 The structure of the inferior vena cava interventional valve in the embodiment of the present application is shown in the figure.

[0022] Reference signs: 1, body support; 101, upper cone part; 102, barrel part; 103, lower cone part; 2, fixing member; 3, artificial valve leaflet; 4, barb. DETAILED DESCRIPTION

[0023] The structure and effects of the present application will be further described in detail below in combination with embodiments. It can be understood that the specific embodiments described herein are only used to explain the present application and are not a limitation of the present application. In addition, it should be noted that, in order to facilitate description, only the parts related to the present application are shown in the drawings, not all structures.

[0024] It is worth mentioning that the so-called "upper" in the embodiment refers to the side of the device after implantation towards the head, and the so-called "lower" refers to the end towards the foot.

[0025] Embodiment

[0026] The embodiment of the present application provides a small-size inferior vena cava interventional valve which is easy to operate. Figure 1 The inferior vena cava interventional valve comprises a body support 1, a fixing member 2, a covering film (not shown in the figure) and an artificial valve leaflet 3. The body support 1 is a lantern-shaped large-mesh hollow nickel-titanium alloy form memory integrated support, which comprises an upper cone body part 101, a barrel part 102 and a lower cone body part 103. The fixing member 2 is a plurality of thin strip-shaped structures which are connected to the joint of the upper cone body part 101 and the barrel part 102, and are unfolded outward and upward, and the tail end is folded inward and upward. The covering film is a high polymer or biological film piece, which is wrapped around the outer periphery of the body support 1 to prevent the generation of paravalvular leakage. The artificial valve leaflet 3 is sutured in the barrel part 102 of the body support 1, is a three-leaflet valve, and is a functional component of the entire device.

[0027] The body support 1 is similar to the inferior vena cava filter commonly used in the clinic at present, is a lantern-shaped large-mesh hollow nickel-titanium alloy form memory support, and three parts are connected together and are formed by one-piece laser cutting and heat setting of a nickel-titanium alloy pipe. In the working state, it is designed to be unfolded into a lantern-shaped natural form, and is compressed into a thin strip shape during transportation, and can be loaded into a thin tubular sheath. The upper cone body part 101 is an upward and inward extension of all longitudinal lines of the barrel part 102, converges at a center point directly above the barrel part 102, and is fixed by a small metal fixing cylinder. The upper cone body part 101 makes the barrel part 102 of the body support 1 extend upward and inward to close, and strengthens the radial support force of the barrel part 102. The barrel part 102 is a barrel-shaped hollow support composed of a rhombic grid and / or a hexagonal cell, which has 1-3 rows in the longitudinal direction and 6-8 large meshes in the transverse direction, and the artificial valve leaflet 3 is sutured in the inner cavity of the barrel part 102 to support the artificial valve leaflet 3. There are also 1-2 small upward barbs 4 on the longitudinal lines of the barrel part 102 to prevent upward displacement of the entire device after implantation.

[0028] The lower cone part 103 is designed similarly to the upper cone part 101, extending downwardly and inwardly from all the longitudinal lines of the barrel part 102, converging at the center point directly below the barrel part 102, and being fixed by a small metal fixing cylinder. One end of the fixing cylinder presses the metal wire of the lower cone part, and the other end has a threaded opening, which can be reversibly connected with the screw of the delivery system. The radial cone design of the lower cone part 103, like the upper cone part 101, strengthens the radial support of the barrel part 102, and makes it easy to be pulled into the lumen by a tubular object, so that the body stent 1 can be easily recovered when the connection screw is not disconnected after the release of the body stent 1. The rhombus and hexagonal cell design of the body stent 1 allows the barrel part 102 to be compressed into a thin strip in the transverse direction, and the radial design of the upper and lower cone parts allows it to be straightened and compressed into a thin strip in the transverse direction.

[0029] The fixing part 2 is a plurality of thin strip structures extending upwardly and outwardly at the junction of the upper cone part 101 and the barrel part 102, i.e. the longitudinal lines of the barrel part 102 of the body stent 1 are bifurcated into two parts, the upward and outward extension being the fixing part 2, and the upward and outward extension being the upper cone part 101. The tail end of the fixing part 2 away from the barrel part 102 is folded upwardly and inwardly, so that it will not pierce the heart tissue around the periphery of the body stent 1. The length of the fixing part 2 is uniform, and the whole forms a conical disc. Preferably, the disc is covered with a polymer film or a biological film, which can prevent paravalvular leakage. On the other hand, the fixing part 2 can be deployed first during the release of the whole device, and during the movement of the interventional valve to the vena cava, it can be clamped in the atrium to assist in the positioning of the valve surgery and prevent displacement of the valve after complete release.

[0030] The covering film is a polymer or biological film sheet, which is sutured around the periphery of the barrel part 102 of the body stent 1 to prevent the occurrence of paravalvular leakage. Preferably, it can partially cover the barrel part 102 (upper half) of the body stent 1 to prevent the barrel stent from blocking the collateral vessels of the vena cava.

[0031] The artificial valve leaflet 3 is sutured in the lumen of the barrel part 102 of the body stent 1, which is a three-leaflet valve, and is a functional component of the whole device, closing during cardiac contraction to prevent blood from flowing back to the distal end of the vena cava, and opening during cardiac diastole to allow blood from the vena cava to flow to the heart.

[0032] The beneficial effects of the present application are that the delivery size of the current inferior vena cava filter is small, only 6F, and the present application improves the basic structure, so it has the same small delivery size and fixing performance; the fixing part allows the valve to be accurately and simply positioned during surgery, reducing the difficulty of surgical operation; the valve can be completely recovered after complete release, improving the safety of the surgery.

[0033] The embodiments are only illustrative of the present application, and are not intended to limit the present application, and those skilled in the art can make modifications to the embodiments without creative contribution after reading the specification, but as long as the modifications are within the scope of the claims of the present application, they are protected by the patent law.

Claims

1. An interventional vena cava valve, characterized in that, The application relates to a prosthesis for heart valve replacement, comprising: a body support, which comprises an upper cone part, a barrel part and a lower cone part, and the upper cone part and the lower cone part are respectively arranged at two ends of the barrel part; a fixing part arranged at the joint of the upper cone part and the barrel part; a film arranged outside the body support; and artificial valve leaflets arranged in the barrel part of the body support.

2. The vena cava interventional valve of claim 1, wherein, The fixing part is unfolded upwards and outwards at the joint of the upper cone part and the barrel part, and the tail end is folded upwards and inwards.

3. The vena cava interventional valve of claim 1, wherein, The barrel part is a barrel-shaped hollow support composed of rhombic cells and / or hexagonal cells.

4. The vena cava interventional valve of claim 3, wherein, The upper cone part is a cone structure formed by extending all longitudinal lines of the barrel part upwards and inwards above the barrel part.

5. The vena cava interventional valve of claim 3, wherein, The lower cone part is a cone structure formed by extending all longitudinal lines of the barrel part downwards and inwards below the barrel part.

6. The vena cava interventional valve of claim 1, wherein, The barrel part is provided with a barb structure outside.

7. The vena cava interventional valve of claim 1, wherein, The film is a high polymer film or a biological film.

8. The vena cava interventional valve of claim 1, wherein, The artificial valve leaflets are tricuspid valves.

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