Recapturable self-expanding short frame valve for aortic regurgitation

Abstract

The present application relates to a kind of short valve frame valve of self-expanding recyclable suitable for aortic valve reflux, including tubular frame and valve leaf, tubular frame can be shrunk to delivery form or expanded to use form in radial direction, tubular frame includes integrally formed and coaxially arranged first part and second part, the junction of first part and second part forms waist when tubular frame is in its use form, second part is gradually expanded and arranged in the direction away from the waist, first part includes gradually expanded portion and inner retraction portion in the direction away from waist, and the ratio of the axial dimension of gradually expanded portion and the inner retraction portion is 2:1;The ratio of the axial dimension of second part and the first part is 1:3;The end of inner retraction portion away from waist is formed with multiple end points, and at least five end points are provided with connecting portion, and the connecting portion is used for detachably connected with the steel wire of valve delivery system.The present application can realize that valve is completely recyclable, and does not affect later coronary intervention.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of aortic regurgitation surgical instruments, in particular to a short valve frame valve suitable for aortic valve regurgitation. BACKGROUND

[0002] At present, transcatheter aortic valve replacement (TAVR) has been widely used in patients with severe aortic valve stenosis, and has become an important method as surgical thoracotomy valve replacement. And TAVR technology is more minimally invasive, and patients recover faster. However, there are still many problems to be solved in the direct use of TAVR technology for aortic valve regurgitation.

[0003] Aortic valve regurgitation is different from aortic valve stenosis. Patients with aortic valve regurgitation have unique anatomical characteristics. First, the valve leaflet of the patient with aortic valve regurgitation is lightly calcified or has no calcification, and the valve leaflet is soft and has no support. Second, the valve annulus of the patient with aortic valve regurgitation is large, the ventricle is large, and the ascending aorta is dilated. Therefore, the several domestic valve membranes specially designed for aortic valve stenosis used for aortic valve regurgitation can only rely on several anchor points such as the valve annulus, the outflow tract, the sinus tube junction and the ascending aorta. However, the problem of valve displacement, valve-in-valve and paravalvular regurgitation still occurs at a high rate during the operation.

[0004] The inventor applied for an invention patent (application number 2021115339418) on December 15, 2021, which discloses a self-expanding valve suitable for aortic valve regurgitation and delivered through the femoral artery approach. It can solve the problems of good valve displacement and paravalvular regurgitation. However, the first part of this technical solution is a corolla shape, which is relatively long. After release, the first part will extend into the ascending aorta, affecting the subsequent coronary intervention, and this valve cannot adjust the release position during release.

[0005] Therefore, a completely recoverable self-expanding short valve frame valve specifically designed for patients with aortic valve regurgitation and released through the femoral artery approach can be designed to achieve one-time positioning and stable release process, without displacement after the operation. The short valve frame facilitates subsequent coronary intervention, and the valve can be completely recovered, which can solve the problem of minimally invasive treatment of many patients with aortic valve regurgitation and has a wide market prospect. SUMMARY

[0006] In view of the defects in the prior art, the technical problem to be solved by the present application is to provide a recoverable self-expanding short valve frame valve suitable for aortic valve regurgitation, which can achieve complete recovery of the valve and does not affect the subsequent coronary intervention.

[0007] To solve the above technical problems, the application provides a short-valve-frame valve suitable for aortic valve regurgitation and capable of being recycled, comprising a tubular frame and valve leaves sewn on the inner periphery of the tubular frame, wherein the tubular frame is provided with a plurality of hollow grids, so that the tubular frame can be shrunk to a delivery form or expanded to a use form in the radial direction, the tubular frame comprises a first part and a second part which are integrally formed and coaxially arranged, when the tubular frame is in the use form, a waist part is formed at the joint of the first part and the second part, the second part is gradually expanded in the direction away from the waist part, the first part comprises a gradually expanded part and a retracted part in the direction away from the waist part, and the ratio of the axial dimensions of the gradually expanded part and the retracted part is 2:1; the ratio of the axial dimensions of the second part and the first part is 1:3; and a plurality of end points are formed at the end of the retracted part away from the waist part, wherein at least five end points are provided with connecting parts for detachable connection with a steel wire of a valve delivery system.

[0008] In use, the tubular frame is shrunk to the delivery form, forming an elongated strip, and is delivered to the aortic valve through the femoral artery under the action of a delivery sheath, and after reaching the target position, the tubular frame is expanded to the use form, at this time, the waist part is just aligned with the original valve ring, and the second part is anchored in the outflow tract, the second part is gradually expanded in the direction away from the waist part, which can stabilize the valve and prevent it from moving away from the heart, thereby making the entire valve release more stable, after the release of the first part, the gradually expanded part of the first part is in close proximity to the valve ring, avoiding the displacement of the valve in the later stage, and the structure and size of the first part are improved, the ratio of the axial dimensions of the second part and the first part is designed to be 1:3, and the length proportion of the first part is shortened, so that after release, the first part is completely located in the sinus tube, i.e., the retracted part does not extend into the ascending aorta, and does not affect the later coronary intervention. In addition, at least five end points of the application are provided with connecting parts for detachable connection with the steel wire of the valve delivery system, if the valve release position is not correct or the valve model is not good, the valve can be completely recycled, if the valve is released well, the steel wire of the delivery system can be separated from the connecting part, and the valve can be completely released.

[0009] Preferably, the connecting part is a threaded stud integrally formed on the end point. An internal thread is correspondingly arranged on the steel wire of the valve delivery system, and the two are connected through the thread, so that when the valve needs to be completely released, the steel wire can be separated from the corresponding threaded stud by rotating the steel wire, thereby achieving separation.

[0010] Preferably, the number of end points is 5-10.

[0011] Preferably, the junction of the converging portion and the diverging portion is located at a first cross section, and the end of the second portion away from the waist is located at a second cross section; the diameter of the first cross section is larger than the diameter of the second cross section when the tubular frame is in the use state. With this design, the first portion can be effectively prevented from moving towards the heart, and the valve can be effectively fixed.

[0012] Preferably, an outer covering is further included, which covers the outer periphery of the second portion and the portion of the diverging portion close to the waist. The design of the outer covering can ensure that the valve contacts the tissue part well and reduces the paravalvular leakage.

[0013] Preferably, the diverging angle of the second portion in the direction away from the waist is 5°-10°.

[0014] Preferably, the tubular frame is made of nickel-titanium alloy material.

[0015] Preferably, the waist is circumferentially distributed with a plurality of positioning marker points.

[0016] Preferably, the positioning marker points are made of gold material.

[0017] Preferably, the material of the outer covering is PET material. BRIEF DESCRIPTION OF DRAWINGS

[0018] In order to more clearly illustrate the specific embodiments of the present application or the technical solutions in the prior art, the drawings needed to be used in the description of the specific embodiments or the prior art will be briefly introduced below. In all the drawings, similar elements or parts are generally identified by similar reference numerals. In the drawings, the elements or parts are not necessarily drawn according to the actual scale.

[0019] Figure 1 Structure schematic diagram of the short-valve-frame valve of the present application for aortic valve regurgitation and suitable for being recycled and self-expanding;

[0020] Figure 2 Structure schematic diagram of the short-valve-frame valve of the present application for aortic valve regurgitation and suitable for being recycled and self-expanding and the connection structure of the steel wire.

[0021] Reference signs:

[0022] 1-first portion; 11-diverging portion; 12-converging portion; 121-connection part; 2-second portion; 3-waist; 31-positioning marker point; 4-outer covering; 5-steel wire. DETAILED DESCRIPTION

[0023] The embodiments of the technical solutions of the present application will be described in detail below with reference to the drawings. The following embodiments are only used to more clearly illustrate the technical solutions of the present application, and therefore only serve as examples, but cannot limit the protection scope of the present application.

[0024] It should be noted that, unless otherwise specified, the technical terms or scientific terms used in the present application should be understood as the general meaning understood by the skilled person in the field to which the present application belongs.

[0025] As shown in Figure 1 and Figure 2 The present embodiment provides a self-expanding short frame valve suitable for aortic valve regurgitation, which comprises a tubular frame and three leaflets (not shown in the figure) sewn on the inner periphery of the tubular frame, and the leaflets are made of porcine pericardium or bovine pericardium. The tubular frame has a plurality of hollow grids, so that the tubular frame can be contracted to a delivery form or expanded to a use form in the radial direction.

[0026] The tubular frame comprises a first part 1 and a second part 2 which are integrally formed and coaxially arranged, and when the tubular frame is in its use form, the connection between the first part 1 and the second part 2 forms a waist 3, and the three leaflets are sewn on the inner periphery of the waist 3.

[0027] The second part 2 is gradually expanded in the direction away from the waist 3, and the gradually expanding angle is 5°-10°, and in the present embodiment, the gradually expanding angle is specifically 7°.

[0028] The first part 1 comprises a gradually expanding part 11 and a converging part 12 in the direction away from the waist 3, and the axial size ratio of the gradually expanding part 11 to the converging part 12 is 2:1; the axial size ratio of the second part 2 to the first part 1 is 1:3.

[0029] In the present embodiment, the design of the converging part 12 can form a avoiding part to prevent the end of the converging part 12 from directly contacting the aortic sinus, and to prevent the occurrence of puncture. In addition, the axial size ratio of the gradually expanding part 11 to the converging part 12 is designed to be 2:1, which can improve the contact strength of the gradually expanding part 11 with the sinus wall, and prevent the occurrence of valve displacement. In addition, the axial size ratio of the second part 2 to the first part 1 is designed to be 1:3, so that after release, the first part 1 will not extend into the ascending aorta, and will not affect the later coronary intervention.

[0030] The outer periphery of the second part 2 and the part of the gradually expanding part 11 close to the waist 3 is covered with an outer covering film 4, and the material of the outer covering film 4 is specifically PET film, which can increase the friction force, so that the tubular frame is well combined with the contacted tissue part, and the paravalvular leakage is reduced.

[0031] Further, the inner portion 12 is formed with a plurality of end points at the end away from the waist 3, in practice, the number of end points is 5-10, in order to facilitate the valve delivery, at least five end points are provided with a connecting portion 121, which is used for detachable connection with the steel wire 5 of the valve delivery system. Specifically, the connecting portion 121 is a threaded stud integrally formed on the end point, and the steel wire 5 of the valve delivery system is provided with an internal thread matched with the threaded stud, and the two are connected through thread connection, when releasing, if the valve release position is not correct or the valve model is not good, the valve can be completely recycled, if the valve is released well, the steel wire 5 is rotated to make the steel wire 5 and the corresponding connecting portion 121 disengage from the thread connection, so that the steel wire of the delivery system and the connecting portion 121 are separated, and the valve is completely released.

[0032] Specifically, the connection between the inner portion 12 and the diverging portion 11 is a first cross section, and the end of the second portion 2 away from the waist 3 is a second cross section; when the tubular frame is in the use state, the diameter of the first cross section is larger than that of the second cross section. With this design, the first portion 1 can be effectively prevented from moving towards the heart, and the valve can be effectively fixed. For example, in practice, if the diameter of the waist 3 is 35mm, the diameter of the second cross section can be 40mm, and the diameter of the first cross section can be 45mm, at this time, the length of the second portion 2 in the axial direction is 10mm, and correspondingly, the length of the first portion 1 in the axial direction is 25-30mm, and in this embodiment, the length of the first portion 1 in the axial direction is 30mm.

[0033] The tubular frame of the embodiment is made of nickel-titanium alloy material, has the property of temperature memory, becomes soft and can be shaped in ice-salt water, can be shrunk from the use shape to the delivery shape, expands automatically in normal temperature (15-40 degrees Celsius, including 37 degrees Celsius of blood), restores the designed shape (i.e. the shape of the use shape), and has high hardness. In use, the tubular frame is shrunk to its delivery shape, forms an elongated strip, the steel wire 5 of the delivery system is screwed with the connecting part 121 of the valve, and is delivered to the aortic valve through the femoral artery under the action of the delivery sheath, and after reaching the target position, the tubular frame expands to its use shape, at this time, the waist part 3 is just aligned with the original valve ring, and since the waist part 3 after release is in the same position as the original valve ring, the position of the valve leaflet of the implanted valve is in the same position as the original valve leaflet; the second part 2 after release anchors the outflow tract, and the second part 2 is gradually expanded in the direction away from the waist part 3, can play a role in stabilizing the valve, so that it cannot be displaced away from the heart, and thus the entire valve release is relatively stable, after the first part 1 is released, the gradually expanded part 11 is in close contact with the valve ring and the aortic sinus wall, avoiding the displacement of the valve downward in the later stage, and the adducted part 12 can avoid piercing the aortic sinus and prevent puncture. After complete release in place, the steel wire 5 is rotated to separate the steel wire 5 and the connecting part 121, so as to realize the complete release of the valve.

[0034] In order to align the waist part with the original valve ring smoothly, the waist part 3 of the embodiment is uniformly distributed with a plurality of positioning mark points 31 made of gold material. In surgery, the positioning mark points 31 can be aligned with the designed mark points at the original valve ring, so that the waist part 3 is just aligned with the original valve ring.

[0035] In the embodiment, the tubular frame is formed by laser engraving technology, and the hollow grid includes a first grid formed on the first part 1 and a second grid formed on the second part 2, and the density of the first grid on the first part 1 is smaller than that of the second grid on the second part 2. The grid of the first part is relatively sparse, so that the entire valve ring stent can be pressed and loaded into a smaller delivery sheath, and the radial section is relatively large, can be attached to the aortic sinus wall or close to the radial section size of the aortic sinus, which is beneficial to its radial fixation without bias and enhances stability; the grid of the second part 2 is relatively dense, so the hardness is relatively large, which can provide better support.

[0036] Further, the hollow grid is a rhombus, and the long axis direction of the rhombus hollow grid is consistent with the axis direction of the tubular frame, so as to form an elongated strip shape when shrunk to the delivery shape.

[0037] In the description of the present application, a large number of specific details are illustrated. It is understood, however, that embodiments of the application can be practiced without such specific details. In some instances, well-known methods, systems and techniques have not been described in detail in order to not obscure the understanding of this description.

[0038] In the description of the present application, the description of the terms "one embodiment", "some embodiments", "an example", "a specific example", or "some examples" etc. means that the specific features, systems, materials or characteristics described in connection with the embodiment or example are included in at least one embodiment or example of the present application. In the present application, the illustrative description of the above terms does not necessarily refer to the same embodiment or example. Moreover, the specific features, systems, materials or characteristics described can be combined in any appropriate manner in any one or more embodiments or examples. In addition, the person skilled in the art can combine and combine the different embodiments or examples described in the present application and the features of the different embodiments or examples without contradiction.

[0039] Finally, it should be noted that: the above embodiments are only used to illustrate the technical solutions of the present application, and not to limit them; although the present application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that: it can still modify the technical solutions recorded in the foregoing embodiments, or make equivalent replacement to part or all of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present application, and they should be covered in the scope of the claims and the description of the present application.

Claims

1.A retrievable self-expanding short frame valve for aortic valve regurgitation, comprising a tubular frame and leaflets sutured on the inner circumference of the tubular frame, the tubular frame having a plurality of hollow grids, so that the tubular frame can be contracted to a delivery form or expanded to a use form in the radial direction, the tubular frame comprising a first part and a second part which are integrally formed and coaxially arranged, the connection between the first part and the second part forming a waist when the tubular frame is in its use form, the second part being gradually expanded in the direction away from the waist, characterized in that: the first part comprises a gradually expanding part and a converging part in the direction away from the waist, and the ratio of the axial dimensions of the gradually expanding part and the converging part is 2:1; the ratio of the axial dimensions of the second part and the first part is 1:3; a plurality of end points are formed on the end of the converging part away from the waist, and at least five of the end points are provided with connecting parts for detachable connection with a steel wire of a valve delivery system; the cross section at the connection between the converging part and the gradually expanding part is a first cross section, and the cross section at the end of the second part away from the waist is a second cross section; the diameter of the first cross section is greater than the diameter of the second cross section when the tubular frame is in the use form; and a plurality of positioning marker points are uniformly distributed on the circumference of the waist. 2.The retrievable self-expanding short frame valve for aortic valve regurgitation according to claim 1, characterized in that: the connecting part is a threaded stud integrally formed on the end point. 3.The retrievable self-expanding short frame valve for aortic valve regurgitation according to claim 1, characterized in that: the number of the end points is 5-10. 4.The retrievable self-expanding short frame valve for aortic valve regurgitation according to claim 1, characterized in that: further comprising an outer covering membrane covering the outer circumference of the second part and the part of the gradually expanding part close to the waist. 5.The retrievable self-expanding short frame valve for aortic valve regurgitation according to claim 1, characterized in that: the gradually expanding angle of the second part in the direction away from the waist is 5°-10°. 6.The retrievable self-expanding short frame valve for aortic valve regurgitation according to claim 1, characterized in that: the tubular frame is made of nickel-titanium alloy material. 7.The retrievable self-expanding short frame valve for aortic valve regurgitation according to claim 1, characterized in that: the positioning marker points are made of gold material. 8.The retrievable self-expanding short frame valve for aortic valve regurgitation according to claim 4, characterized in that: the material of the outer covering membrane is PET material. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​

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