Multi-delivery site asymmetrically positioned transvalvular catheter

Abstract

The application discloses a multi-delivery-site asymmetric positioning cross-valve catheter, and particularly relates to the technical field of cross-valve catheters, which comprises an expansion piece, a guide sheath and movable pieces. The expansion piece is provided with through grooves penetrating through the peripheral wall, and the number of the through grooves is at least one; accordingly, the through grooves divide the expansion piece into at least two sub-pieces; one end of each of the sub-pieces is connected through a closed ring-shaped part, and the other end of each of the sub-pieces is fixed with a single movable piece; the number of the movable pieces is matched with the number of the sub-pieces; each of the sub-pieces is provided with an expansion part, and the expansion part comprises at least four mechanical sub-pieces; the head of the guide sheath is arranged in the hollow interior of the closed ring-shaped part, and the middle part of the guide sheath is provided with a hole through which a cross-valve guide wire passes. The cross-valve catheter pushes the tail pipe of the sub-piece, so that the mechanical sub-pieces have different expansion sizes, the outer sides of the mechanical sub-pieces are attached to the ascending aorta, the coaxiality of the distal end opening of the catheter and the expected cross-valve point is improved, and the catheter is stabilized.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of transvalvular catheter, and particularly relates to a multi-delivery site asymmetric positioning transvalvular catheter. BACKGROUND

[0002] TAVR is a minimally invasive interventional operation for treating severe aortic stenosis (AS) or regurgitation (AR). It implants an artificial heart valve into the body through a catheter (usually through the femoral artery or the apex of the heart), replacing the diseased aortic valve without thoracotomy and extracorporeal circulation. The incidence of aortic stenosis is 3%-5% in people over 75 years old, and the number of patients continues to grow as the aging population intensifies. About 30%-40% of AS patients cannot tolerate traditional thoracotomy due to age, comorbidities (such as COPD, coronary heart disease), and transcatheter aortic valve replacement (TAVR) has become an important method for treating severe aortic stenosis (AS), especially for patients at high risk or contraindicated for surgical operation.

[0003] TAVR surgery is generally performed through the femoral artery approach, and a guide wire or catheter is used to cross the stenotic aortic valve from the ascending aorta into the left ventricle to establish a passage for subsequent valve implantation. Currently, transvalvular surgery failures mainly occur in cases of severe calcification, bicuspid aortic valve (BAV) or extremely severe stenosis. The main reasons are as follows: 1) the shape of the catheter does not match the aortic root

[0004] Its distal end is large and curved, designed to embed the left coronary artery opening, but when crossing the valve, it may cause excessive bending, making it difficult to align the catheter distal opening with the center of the aortic valve (towards the sinus tube junction or the edge of the valve leaflet). In Type 0 (bicuspid valve) or horizontal aorta, the catheter may be stuck between the valve leaflet and the aortic wall, increasing the difficulty of crossing the valve.

[0005] 2) When there is partial aortic stenosis, adhesion or calcification occurs between the center of the main valve or the valve leaflets. In this case, the transvalvular operation often occurs in the gap between the two valve leaflets rather than the center of the main valve, making it more difficult to cross the valve, requiring repeated trials, and even failing to succeed.

[0006] 3) Difficulty in stabilizing the catheter above the valve leaflet

[0007] During the operation, the blood flow caused by the beating heart and the opening and closing of the valve leaflets makes the catheter always active. At this time, the guide wire is extended out of the catheter, and it is difficult to cross the aortic valve. The learning curve of doctors is long, and it takes about 50-100 TAVR operations for a new heart interventionalist (such as one who has just completed coronary intervention training) to become proficient. For complex cases (bicuspid valve, extremely horizontal heart, severe calcification), even experienced operators may face challenges and need additional training or expert guidance. SUMMARY

[0008] The application provides a multi-delivery-site asymmetrically positioned transvalvular catheter.

[0009] The application aims to achieve the above-mentioned technical problems by the following technical scheme.

[0010] The application provides a multi-delivery-site asymmetrically positioned transvalvular catheter, which comprises an expansion member, a guide sheath and movable members.

[0011] The expansion member is cut from a pipe material, and the mechanical segments can be expanded into a lantern shape with a diameter of 20mm-50mm by pushing the tail of the subsegment.

[0012] The guide sheath is loaded in the expansion member and has a guide wire lumen.

[0013] The head end of the mechanical segment is fixedly installed on the guide sheath, and the tail end is fixedly connected with the movable member.

[0014] The movable member controls the expansion of the mechanical segment, and the tail of the subsegment is fixedly connected with the movable member.

[0015] Preferably, the transvalvular catheter further comprises a handle, and the handle is provided with a containing groove suitable for the movement of the movable member.

[0016] Preferably, the number of the subsegments is two, and the number of the movable members is also two.

[0017] As preferred, the guide sheath is provided with a fixed end head near one end of the closed ring, and the other end is fixed with the handle.

[0018] As preferred, the handle is provided with an outer sheath, and the outer sheath is provided with a hole for inserting the expansion member.

[0019] As preferred, the handle is provided with an indication scale, and the indication scale is located at the upper end of the accommodation groove.

[0020] As preferred, the expansion member is made of a nickel-titanium memory alloy material or a PEEK or PI material.

[0021] As preferred, the outer sheath is made of a PEEK material.

[0022] As preferred, the diameter of the expansion member after expansion is 20mm-50mm.

[0023] As preferred, the distance between the end of the outer sheath away from the handle and the connection between the sub-piece and the expansion part is ≥10mm.

[0024] Compared with the prior art, the technical scheme of the present application has the following advantages or beneficial effects:

[0025] (1) The expanded transvalvular catheter fits the ascending aorta, so that the distal opening of the catheter is aligned with the center of the aortic valve.

[0026] (2) For cases with calcification or adhesion in the center of the main valve, the eccentricity of the catheter can be adjusted to improve the coaxiality of the distal opening of the catheter and the expected transvalvular opening. This is conducive to the delivery of the transvalvular guide wire to the expected transvalvular puncture point. Therefore, the delivery site of the transvalvular guide wire can be changed according to the actual situation of different patients, and the transvalvular guide wire can be delivered to an asymmetric site through the transvalvular catheter, greatly increasing the success rate of the operation.

[0027] (3) The stable catheter is above the main valve, and at this time only the guide wire needs to be pushed back to explore the transvalvular, reducing the operation difficulty of the doctor. BRIEF DESCRIPTION OF DRAWINGS

[0028] Figure 1 It is a schematic diagram of the three-dimensional structure of a transvalvular catheter with multiple delivery sites and asymmetric positioning;

[0029] Figure 2 It is a schematic diagram of the cross-sectional structure of a transvalvular catheter with multiple delivery sites and asymmetric positioning;

[0030] Figure 3 It is a three-dimensional structure diagram of the expansion member (symmetric);

[0031] Figure 4 It is a three-dimensional structure diagram of the expansion member (asymmetric);

[0032] Figure 5 Schematic diagram for crossing the aortic arch with a guide wire;

[0033] Figure 6 Schematic diagram for uniform distribution of mechanical segments;

[0034] Figure 7 Schematic diagram for the inflated balloon to conform to the aortic arch (uniform distribution);

[0035] Figure 8 Schematic diagram for the inflated balloon to conform to the aortic arch (non-uniform distribution).

[0036] In the figure: 2, balloon, 3, guide sheath, 4, segment, 5, through slot, 6, outer sheath, 7, handle, 8, indicating scale, 9, movable part, 10, closed ring. DETAILED DESCRIPTION

[0037] The embodiments of the present application will be described in detail below with reference to the drawings and examples, so that how the present application applies technical means to solve technical problems and achieves corresponding technical effects can be fully understood and implemented. The embodiments of the present application and each feature in the examples can be combined with each other without conflict, and the formed technical solutions are all within the protection scope of the present application.

[0038] It should be clear that the embodiments described below are only some of the embodiments of the present application, not all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor are within the scope of protection of the present application.

[0039] Embodiment 1: This embodiment describes in detail the specific structure of a multi-delivery site asymmetrically positioned transvalvular catheter:

[0040] The product is composed of a guide sheath, an inflatable part, an outer sheath, a handle and at least two movable parts, and the maximum insertion outer diameter of the catheter is 9-10F, and the insertion length is ≥500cm.

[0041] Wherein, the expansion piece is cut from a pipe, the head of the pipe is a closed ring, the tail of the pipe is cut into at least two pieces (i.e. sub-pieces), and the middle section of the pipe is cut into at least four pieces (i.e. mechanical pieces), forming an integral whole. When the tails of the sub-pieces are pushed to the same scale at the same time, the mechanical pieces can be expanded into a lantern shape, and the diameter of the lantern-shaped mechanical pieces is 20mm-50mm. Alternatively, the tails of the sub-pieces can be independently pushed to different scales, so that the mechanical pieces can be expanded to different sizes, to adapt to the positioning of the aortic valve stenosis eccentricity. In theory, the more the number of sub-pieces, the higher the fit between the different mechanical pieces and the inner wall of the aorta after adjusting to different expansion degrees. In the present embodiment, as shown in Figure 1 , the number of sub-pieces is two. The expansion piece is generally made of nickel-titanium memory alloy material or high polymer material (such as PEEK, PI, etc.).

[0042] Embodiment 2: The application scheme of a multi-delivery site asymmetric positioning transvalvular catheter is described in detail in the present embodiment:

[0043] As shown in Figure 3 , Figure 6 and Figure 7 , when the aortic valve stenosis is evenly distributed, the transvalvular catheter generally passes through the center of the aortic valve leaflet, at which time the two expansion pieces are pushed to the same size, the lantern is opened, and the lantern is close to the ascending aorta. At this time, the guide wire is stretched out from the inner sheath and can pass through the center of the valve leaflet. Figure 3 , Figure 6 and Figure 7 , the red line part represents the distribution of the mechanical pieces.

[0044] Embodiment 3: The application scheme of a multi-delivery site asymmetric positioning transvalvular catheter is described in detail in the present embodiment:

[0045] When the aortic valve stenosis is unevenly distributed, if the transvalvular catheter is coaxial with the aortic valve, the guide wire will shuttle at the calcified stenosis all the time, and cannot pass through the center of the annulus. At this time, the transvalvular catheter needs to be decentered with the ascending aorta. The size of the ascending aorta / calcified stenosis region is evaluated through the CT report before the operation, and the expansion form and size requirement of the expected expansion piece are measured.

[0046] As shown in Figure 8 , when the diameter of the ascending aorta is 35mm, the transvalvular puncture point is expected to be in the gap between the two valve leaflets, rather than the center of the main valve. According to the simulation data measured from the CT report, the radius of a part of the leaflet is 26 (2 red lines); the radius of a part of the leaflet is 19 (2 purple lines), and the radius of a part of the leaflet is 7 (4 green lines); at this time, there are three active pieces 9, and the catheter is adjusted to the puncture point.

[0047] InFigure 4 In the middle, the size of the two different mechanical leaflets after expansion is shown for reference, giving a more intuitive understanding.

[0048] In the operation, the tail of different expansion members is pushed respectively, so that the middle section presents different expansion sizes of 26mm / 7mm. When the lantern-shaped mechanical leaflet is fully opened, it is close to the ascending aorta. At this time, the guide wire is stretched out from the inner sheath and can cross the valve leaflet from the expected position. In the process of adjusting the site, the two movable members shown in Figure 1 can be rotated to rotate the lantern-shaped mechanical leaflet, and the guide wire is stretched out from the inner sheath to cross the valve, so that the transvalvular guide wire puncture operation can be realized.

Claims

1. A multi-delivery site asymmetrically positioned transvalvular catheter, comprising: The expansion member, the guide sheath (3) and the movable member (9); The expansion member is provided with through-slots (5) in the circumferential wall, the number of the through-slots (5) is at least one, and correspondingly, the through-slots (5) divide the expansion member into at least two sub-pieces (4); One end of each of the sub-pieces (4) is connected through a closed ring-shaped part (10), and the other end of each of the sub-pieces is fixed with a single movable member (9), the number of the movable members (9) is matched with the number of the sub-pieces (4); Each of the sub-pieces (4) is provided with an expansion part (2), and the expansion part (2) comprises at least four mechanically divided pieces; The head of the guide sheath (3) is arranged in the hollow interior of the closed ring-shaped part (10), and the middle part of the guide sheath (3) is provided with a hole through which a crossing-valve guide wire is adapted to pass; The handle (7) is further provided with a containing groove adapted to the movement of the movable member (9); The end of the guide sheath (3) close to the closed ring-shaped part (10) is provided with a fixed end (1), and the other end is fixed with the handle (7); the handle (7) is provided with an outer sheath (6), and the outer sheath (6) is provided with a plug hole adapted to the insertion of the expansion member.

2. The multi-delivery site asymmetrically positioned transvalvular catheter of claim 1, wherein, The number of the sub-pieces is two, and correspondingly, the number of the movable members (9) is also two; the two movable members (9) are freely slidably arranged in the containing groove, and the two movable members (9) are respectively fixed with the two sub-pieces.

3. The multi-delivery site asymmetrically positioned transvalvular catheter of claim 1, wherein, The handle (7) is provided with an indicating scale (8) at the upper end of the containing groove.

4. The multi-delivery site asymmetrically positioned transvalvular catheter of claim 1, wherein, The expansion member is made of a nickel-titanium memory alloy material or a PEEK or PI material.

5. The multi-delivery site asymmetrically positioned transvalvular catheter of claim 1, wherein, The outer sheath is made of a PEEK or PI material.

6. The multi-delivery site asymmetrically positioned transvalvular catheter of claim 1, wherein, The diameter of the expansion member after expansion is 20mm-50mm.

7. The multi-delivery site asymmetrically positioned crossing-valve catheter according to claim 1, wherein the distance between the end of the outer sheath (6) away from the handle (7) and the connection between the sub-piece (4) and the expansion part (2) is greater than or equal to 10mm.

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