Pulmonary artery band conduit and method of suturing same

Abstract

This invention discloses a pulmonary artery valved conduit, comprising a conduit body and a valve. The valve is disposed on the inner wall of the conduit body and includes at least one leaflet. Each leaflet has a suture portion, which is fixed to the inner wall of the conduit body by a suture. In at least a portion of the suture, some sutures run in the opposite direction to the suturing direction of the suture portion, while others run in the same direction. Sutures running in the same direction as the suture portion alternate with sutures running in the opposite direction. Furthermore, the stitch span of the sutures running in the same direction as the suture portion is greater than that of the sutures running in the opposite direction. This invention also discloses a method for suturing the above-described pulmonary artery valved conduit. The pulmonary artery valved conduit provided by this invention exhibits excellent hemodynamics and durability.

Description

Technical Field

[0001] This invention relates to a pulmonary artery valved conduit and a method for suturing it. Background Technology

[0002] Expanded polytetrafluoroethylene (ePTFE) is a high-performance polymer material with a unique microporous structure, excellent biocompatibility, outstanding chemical stability and anti-calcification properties. Pulmonary artery valved conduits made of ePTFE can be used for right ventricular outflow tract reconstruction in complex congenital heart diseases such as ROSS surgery, tetralogy of Fallot, and pulmonary atresia.

[0003] Despite the significant advantages of ePTFE material itself, achieving a strong, durable, and hemodynamically optimized suture connection between the valve leaflet and the conduit body during manufacturing remains a key technological bottleneck that restricts its full performance.

[0004] Currently, the manufacturing and testing of ePTFE-based pulmonary artery valved conduits still face several core challenges:

[0005] First, ePTFE pulmonary artery valved conduits suffer from micro-leakage between the valve leaflets and the inner wall of the conduit body, a problem known as "leakage." Second, in hydrodynamic durability tests simulating physiological environments, if the leaflet structure and suture method are mismatched, premature tearing may occur at the leaflet edges or in areas of stress concentration, preventing the conduit from meeting the basic requirement of at least 200 million cycles as stipulated in the national standard GB / T 12279.1-2024. Crucially, current processes often suture the leaflets with the conduit in an everted state. If the leaflet design fails to precisely match the curvature of the conduit in its post-implantation working state, local collapse or deformation may occur in the suture area when the conduit is returned to its implanted state. This structural depression disrupts the smoothness of the flow path, inducing non-physiological turbulence, increasing the risk of thrombosis, and exacerbating suture tearing under long-term cyclic loading, leading to premature valve failure. These interconnected technical problems severely restrict the long-term durability of ePTFE pulmonary artery valved conduits. Summary of the Invention

[0006] The purpose of this invention is to overcome the shortcomings of the prior art and provide a pulmonary artery valved conduit and its suturing method to solve the problems existing in the prior art, such as leakage, easy tearing of the valve leaflets, and the outer wall of the conduit body being concave due to mismatch between the suturing state and the working state, and the valve failing before 200 million cycles of testing.

[0007] As one aspect of the present invention, a pulmonary artery valved conduit is disclosed, comprising a conduit body and a valve, the valve being disposed on the inner wall of the conduit body, the valve comprising at least one leaflet, the leaflet having a suture portion, the suture portion being fixed to the inner wall of the conduit body by a suture; in at least a portion of the suture, a portion of the suture runs in the opposite direction to the suturing direction of the suture portion, a portion of the suture runs in the same direction as the suturing direction of the suture portion, the sutures running in the same direction as the suturing direction of the suture portion alternate with the sutures running in the opposite direction to the suturing direction of the suture portion, and the stitch span of the sutures running in the same direction as the suture portion is greater than the stitch span of the sutures running in the opposite direction to the suturing direction of the suture portion.

[0008] In a specific embodiment, the stitch span of the suture line in the same direction as the suture part is between 2.0 mm and 3.0 mm, and the stitch span of the suture line in the opposite direction to the suture part is between 1.0 mm and 1.5 mm.

[0009] In a specific embodiment, the stitch span of the suture line in the same direction as the suture section is twice the stitch span of the suture line in the opposite direction to the suture section.

[0010] In a specific embodiment, the distance between two sutures that are opposite to the suturing direction of the suture portion is ≤ the stitch span of the suture that is opposite to the suturing direction of the suture portion.

[0011] In a specific embodiment, the suture is a single loop of suture.

[0012] In a specific embodiment, the stitch span of the suture line, which is opposite to the suturing direction of the suture section, is located on the inner wall surface of the pipe body.

[0013] In a specific embodiment, the number of leaflets is three, and the three leaflets are connected as a whole or by sutures.

[0014] In a specific embodiment, the number of the leaflets is one.

[0015] In a specific embodiment, the leaflet is also fixed to the inner wall of the pipe body by a locking line and a winding line.

[0016] As another aspect of the present invention, a method for suturing a pulmonary artery valved conduit as described above is provided, comprising the following steps:

[0017] Step 1: Turn the pipe body outward so that the inner wall of the pipe body faces outward;

[0018] Step 2: Lay out the valve leaflets and attach them to the predetermined position on the inner wall of the everted tube body;

[0019] Step 3: Use sutures to suture the sutured part to the inner wall of the tube body to form the shape of the pulmonary artery valved tube described above;

[0020] Step 4: After suturing, turn the tube back to the implanted position.

[0021] The pulmonary artery valved conduit provided by this invention can withstand more than 200 million durability tests, has a low leakage percentage, is not easily torn, and the outer wall of the conduit body has no local depressions in the implanted state, ensuring the smoothness of the flow channel and excellent hemodynamics and durability. Attached Figure Description

[0022] Figure 1 This is a schematic diagram of the valve in Example 1.

[0023] Figure 2 This is a schematic diagram showing the valve fixed to the inner wall of the pipe body when the pipe is turned outward in Example 1.

[0024] Figure 3 This is a schematic diagram of the suture pattern a formed by the suture line in Example 1.

[0025] Figure 4 This is a schematic diagram showing the valve fixed to the inner wall of the pipe body when the pipe is turned outward in Example 2.

[0026] Figure 5 This is a schematic diagram of the suture pattern b formed by the suture line in Example 2.

[0027] Figure 6 This is a schematic diagram showing the valve fixed to the inner wall of the pipe body when the pipe is turned outward in Example 3.

[0028] Figure 7 This is a schematic diagram of the connection part being fixed to the inner wall of the pipe body in Example 4;

[0029] Figure 8 This is a schematic diagram of the suture shape c formed by the suture line in Example 4.

[0030] Figure 9 This is a schematic diagram of the valve in Example 5.

[0031] Figure 10 This is a schematic diagram of the valve in Example 6.

[0032] Figure 11 This is a schematic diagram of the valve in Example 7.

[0033] Figure 12 This is a schematic diagram of the suture pattern d formed by the suture line.

[0034] Figure 13This is a schematic diagram of the suture shape e formed by the suture line in Comparative Example 1.

[0035] Reference numerals: 1. Pipe body; 101. Pipe wall; 2. Valve; 201. First leaflet; 202. Second leaflet; 203. Third leaflet; 301. Butt joint; 302. Inflow side; 303. Leaflet junction (excluding the butt joint); 304. Outflow side; 305. Pre-drilled hole; 4. Suture line; 5. Locking edge line; 6. Wrapping thread; 701. First pinhole; 702. Second pinhole; 703. Third pinhole. Detailed Implementation

[0036] The pulmonary artery valved conduits disclosed in the prior art can be found in documents such as CN106473840B, CN119055410B, CN109567979A, US20130073037A1, and CN119711018B. The main difference between the present invention and the pulmonary artery valved conduits disclosed in the prior art is that the present invention improves the suturing method of the pulmonary artery valved conduits in order to solve the problems of leakage, easy tearing of valve leaflets, and the outer wall of the conduit body 1 being concave due to mismatch between the suturing state and the working state, and the valve 2 failing before 200 million cycles of testing.

[0037] The pulmonary artery valved conduit provided by this invention includes a conduit body 1 and a valve 2, wherein the valve 2 is disposed on the inner wall of the conduit body 1 via a suture 4. The conduit body 1, valve 2, and suture 4 are all made of ePTFE. The wall thickness of the conduit body 1 is 0.1-1 mm, and the density of the conduit body 1 is 0.57 g / cm³. 3 -0.62g / cm 3 Valve 2 has a wall thickness of 0.1 mm and a density of 0.83 g / cm³. 3 -1.25g / cm 3 .

[0038] The suture portion described in this invention refers to the area on the valve 2 where the leaflets of the valve 2 are fixed relative to the inner wall of the conduit body 1 through a suturing operation. The suture portion can be a continuous area or several discontinuous areas. This invention does not limit the specific location and shape of the suture portion. In some embodiments of this invention (such as...), the suture portion can be defined as follows: Figure 10 In this embodiment, the stitching portion includes a butt joint edge 301 and an inflow edge 302. In other embodiments of the present invention (such as...), the stitching portion includes a butt joint edge 301 and an inflow edge 302. Figure 1 and Figure 9In this invention, the sutured portion includes an inflow edge 302, a leaflet junction 303 excluding the docking portion, and a docking portion formed by two docking edges 301. The core of this invention lies in solving problems such as leakage, easy tearing of the leaflets, and the indentation of the outer wall of the pipe body 1 due to mismatch between the sutured state and the working state, as well as the failure of the valve 2 before 200 million cycles, by improving the suture method at least in part of the sutured portion. It should be particularly noted that when the leaflets are also fixed to the inner wall of the pipe body 1 by a locking line 5, the suture method of the sutured portion described in this invention does not include the locking line.

[0039] The suturing direction of the suture portion, as referred to in this invention, means the direction of the larger of the first two stitch spans of the suture line within the portion of the morphology to be protected by this invention, along a suture line. That is, as shown... Figure 5 and Figure 6 The stitching pattern shown is centered on the first needle hole 701 of the first larger stitch span, and the direction of the second needle hole 702 is the stitching direction of the stitching part as referred to in this invention.

[0040] In this invention, it is not required that the entire length of the suture be of the form claimed by this invention; rather, it is sufficient if a portion of the suture segment exhibits the form claimed by this invention. For example... Figure 12 The suture pattern shown, starting from the third pinhole 703, is the pattern claimed by the present invention. It should be noted that in this figure, the starting direction of the suture line is opposite to the suture direction of the suture portion as referred to in the present invention. The suture direction of the suture portion as referred to in the present invention is only the starting point of the first pinhole (third pinhole 703) that conforms to the pattern claimed by the present invention.

[0041] The stitch span mentioned in this invention refers to the distance between two suture holes (needle holes) directly connected by the suture thread, that is, the straight-line distance traveled by the suture needle when it passes through the inner wall of the pipe body 1 twice consecutively. In this invention, the stitch span of the suture thread in both directions is recorded as the absolute value of the straight-line distance between the two needle holes corresponding to the stitch.

[0042] The first stitch span mentioned in this invention refers to the stitch span of the suture 4 in at least a portion of the suture line, which is in the same direction as the suturing direction of the suture portion. Specifically, the first stitch span is as follows: Figure 5 , Figure 6 and Figure 12 As shown.

[0043] The second stitch span described in this invention refers to the stitch span of the suture line in at least a portion of the suture line, which is opposite to the suturing direction of the suture portion. Specifically, the second stitch span is as follows: Figure 5 , Figure 6 and Figure 12 As shown.

[0044] The corresponding pinholes mentioned in this invention refer to the two closest pinholes among two adjacent pinholes formed by two backward-stitched sutures 4, in at least a portion of the suture line. Specifically, as shown in the example... Figure 6 As shown.

[0045] The technical solution of the present invention will be described in detail below with specific embodiments. In the technical solution of the present invention, the constituent parts of the pulmonary artery valved conduit and their relative positions and fixation relationships can be understood by those skilled in the art by referring to existing technologies. The present invention is explained using only one example of a single-loop suture, which is readily understood by those skilled in the art; of course, two or more loops of suture can also be used.

[0046] Example 1

[0047] like Figure 1-3 As shown, this embodiment provides a pulmonary artery valved conduit, which includes a conduit body 1 and a valve 2 sutured to the inner wall of the conduit body 1 by sutures 4. The valve 2 consists of three leaflets connected in one piece, which are sheet-like. The valve 2 is divided into a first leaflet 201, a second leaflet 202, and a third leaflet 203, and is obtained by cutting it as a whole using a cutting instrument.

[0048] The leaflet has a suture portion and an outflow edge 304. The leaflet is at least partially fixed to the inner wall of the pipe body 1 by the suture portion. In this embodiment, the suture portion includes a mating edge 301, an inflow edge 302, and a leaflet junction 303 excluding the mating portion. A mating edge 301 is arranged on the first leaflet 201, and a mating edge 301 is arranged on the third leaflet 203. The two mating edges 301 are joined together to form a mating portion.

[0049] The parameters of valve 2 are as follows: the two mating edges 301 have the same shape and size; the inflow edges 302 of each leaflet have the same size and shape; the outflow edges 304 of each leaflet have the same size and shape; along the blood flow direction, the maximum axial length from the outflow end of mating edge 301 to the outflow edge 304 is H1; the axial length of mating edge 301 is H2; and the maximum axial length from the inflow end of mating edge 301 to the inflow edge 302 is H3. The width of the outflow edge 304 is L1, and the width of the mating edge 301 is L2.

[0050] The parameters of the pipe body 1 and valve 2 used in the following embodiments are as follows: inner diameter of pipe body 1: 16mm, H1: 4mm, H2: 6mm, H3: 5mm, L1: 47.1mm, L2: 1.5mm.

[0051] Before suturing, the pipe body 1 is turned outward so that the inner wall of the pipe body 1 faces outward. The first leaflet 201, the second leaflet 202, and the third leaflet 203 surround the inner wall surface of the pipe body 1. The first leaflet 201, the second leaflet 202, and the third leaflet 203 are laid and attached to the predetermined position on the inner wall of the turned-out pipe body 1. The two mating edges 301 are overlapped and aligned to form the mating part.

[0052] The suture portion is sewn to the inner wall of the pipe body 1 using suture 4. During sewing, at least a portion of the suture portion is fixed to the inner wall of the pipe body 1 using suture 4. The stitch span of suture 4 is 1.3 mm. A schematic diagram of the suture shape a formed by suture 4 at the suture portion is shown below. Figure 3 As shown, to better illustrate the suturing method, suture line 4 in the figure is not taut.

[0053] Fluid dynamics testing

[0054] The 10 pulmonary artery valved conduits obtained in Example 1 were subjected to hydrodynamic testing.

[0055] In accordance with the standards of GB / T 12279.1-2024, ISO 5840-1:2021, and ISO 5840-2:2021, durability tests were conducted under conditions of a shut-off pressure differential of 20 mmHg and a frequency of 20 Hz. The number of hydrodynamic tests was recorded when valve tearing was observed visually. After 200 million accelerated hydrodynamic tests, if the pipe body was turned outwards so that the inner wall of the pipe body faced outwards while still operating normally, the pressure was gradually increased from a shut-off pressure differential of 20 mmHg to 90 mmHg until valve 2 showed obvious tearing, and the final failure mode was recorded.

[0056] Every 20 million to 50 million fluid dynamics tests, under the conditions of cardiac output of 5.0 L / min and heart rate of 70 cycles per minute, pulsatile flow experiments were performed on valved vessels. The percentage of closed flow and the percentage of leakage flow were recorded (regurgitation percentage = percentage of closed flow + percentage of leakage flow), and the average percentage of closed flow and the average percentage of leakage flow were calculated.

[0057] The experimental results are shown in the table below:

[0058] Table 1: Hydrodynamic test results of the pulmonary artery valved conduit obtained in Example 1

[0059]

[0060] The pulmonary artery valved conduit obtained in Example 1 suffered leaflet tearing after 20 million cycles of durability testing, and valve 2 of the valved conduit failed after 50 million cycles of durability testing.

[0061] Example 2

[0062] like Figure 4 , Figure 5 and Figure 12 As shown, the main difference between Embodiment 2 and Embodiment 1 is that: the sutured part is fixed to the inner wall of the pipe body 1 by suture 4. In at least a portion of the suture 4, some suture 4 runs in the opposite direction to the suturing direction, and some suture 4 runs in the same direction as the suturing direction of the sutured part. Suture 4 running in the same direction as the suturing direction of the sutured part and suture 4 running in the opposite direction to the suturing direction of the sutured part alternate. Furthermore, the stitch span of the suture 4 running in the same direction as the suturing direction of the sutured part (e.g., ...) Figure 5 The first stitch span in the middle) is greater than the stitch span of suture line 4, which is in the opposite direction to the suture direction of the suture (e.g., Figure 5 The second stitch span in the middle). The stitch span of suture line 4, which is opposite to the suturing direction of the suture section (e.g., Figure 5 The second pin span in the pipe body 1 is located on the inner wall surface of the pipe body 1.

[0063] In this embodiment, the first stitch span is 2.6 mm, and the second stitch span is 1.3 mm. The specific suturing operation can be as follows: the needle is inserted into the tube wall 101 and valve 2 of the tube body 1 to form the first needle hole 701 on the inner wall of the tube body 1. Then the needle is inserted out from the tube wall 101 of the tube body 1 to form the second needle hole 702. Then the needle is inserted into the tube wall 101 and valve 2 to form the third needle hole 703. The suture line between the first needle hole 701 and the second needle hole 702 is in the same direction as the suturing direction of the suture part, and the suture line between the second needle hole 702 and the third needle hole 703 is in the opposite direction to the suturing direction of the suture part.

[0064] In this embodiment, it is not required that the starting direction of the suture line be in the same direction as the suturing direction of the suture portion as referred to in this invention. Figure 12 As shown, the starting direction of the suture is opposite to the suturing direction of the suture portion as referred to in this invention. The suturing direction of the suture portion as referred to in this invention is only the starting point of the first pinhole (third pinhole 703) in the form that conforms to the protection claimed in this invention.

[0065] In at least a portion of the suture line, the corresponding needle hole spacing is 0, that is, in at least a portion of the suture line, the stitch span formed by two adjacent suture lines 4 that are opposite to the suturing direction of the suture part (i.e., two adjacent second stitch spans) passes through the same needle hole.

[0066] A schematic diagram of the suture pattern b formed by suture 4 is shown below. Figure 5 As shown. To illustrate the suturing method more clearly, suture line 4 in the figure is not taut.

[0067] The following is a detailed description of the suturing method of this embodiment, including the following steps:

[0068] Step 1: Turn the pipe body 1 outward so that the inner wall of the pipe body 1 faces outward;

[0069] Step 2: Lay the leaflets of valve 2 and attach them to the predetermined position on the inner wall of the everted tube body 1, align the edges that need to be sutured, and align the two mating edges 301 to form the mating part.

[0070] Step 3: Sew the suture part to the inner wall of the pipe body 1 using suture 4. The suture operation alternates between suture 4 in the same direction as the suture part and suture 4 in the opposite direction to the suture part in at least a portion of the suture line. In this embodiment, various sequences can be used to fix the suture part to the inner wall of the pipe body 1 using suture 4. For example, the following sequence can be used for suturing:

[0071] (1) A first row of stitching lines 4 is formed in the direction from the outflow end of the pipe body 1 to the inflow end of the pipe body 1.

[0072] (2) The suture line 4 of the inflow edge 302.

[0073] (3) The second row of stitching lines 4 of the joint is formed in the direction from the inflow end of the pipe body 1 to the outflow end of the pipe body 1.

[0074] (4) Suture line 4 at the junction of the third leaflet 203 and the second leaflet 202, and suture line 4 at the junction of the second leaflet 202 and the first leaflet 201.

[0075] The suture 4 in steps (1)-(4) above is a single loop of suture. The number of sutures 4 used in steps (1)-(3) above is one. The number of sutures 4 used in (4) is two. (4) can be... Figure 3 The suturing method shown can also be used. Figure 5 The suturing method shown is used. In this embodiment, (4) uses... Figure 5 The suturing method shown is used for suturing.

[0076] Fluid dynamics testing

[0077] The 10 pulmonary artery valved conduits obtained in Example 2 were subjected to hydrodynamic testing. The experimental results are shown in the table below:

[0078] Table 2: Hydrodynamic test results of the pulmonary artery valved conduit obtained in Example 2

[0079]

[0080] In Example 2, the pulmonary artery valved conduit obtained underwent 200 million durability tests without leaflet tearing, and the valve 2 of the pulmonary artery valved conduit functioned normally.

[0081] Example 3

[0082] Compared to Example 2, in this example, the schematic diagram of the suture shape c formed by the suture 4 is as follows: Figure 6 As shown. To illustrate the suturing method more clearly, suture line 4 in the figure is not taut.

[0083] In at least a portion of the suture 4, the corresponding needle hole spacing is 0.50 mm (i.e., the spacing between two sutures 4 that are opposite to the suturing direction of the suture is 0.50 mm, or described as the span between two adjacent second stitches is 0.50 mm).

[0084] The 10 pulmonary artery valved conduits obtained in Example 3 were subjected to hydrodynamic testing. The experimental results are shown in the table below:

[0085] Table 3: Hydrodynamic test results of the pulmonary artery valved conduit obtained in Example 3

[0086]

[0087] In Example 3, the pulmonary artery valved conduit experienced leaflet tearing after 230 million durability tests and valve 2 failure after 250 million durability tests.

[0088] Example 4

[0089] like Figure 7 and Figure 8 As shown, the main difference between this embodiment and embodiment 2 is that, in addition to the suture line 4, the inflow edge 302 is also fixed to the inner wall of the pipe body 1 by the locking line 5, and the docking part is also fixed to the inner wall of the pipe body 1 by the winding line 6.

[0090] This embodiment uses the following sequence for suturing:

[0091] (1) Form the first row of stitching lines 4 and winding lines 6 at the joint in the direction from the outflow end of the pipe body 1 to the inflow end of the pipe body 1:

[0092] ① At the outlet end of the docking section, first insert the needle into the docking section and the pipe wall 101 of the pipe body 1, and then insert it out from the pipe wall 101 of the pipe body 1. Repeat the operation twice to form two loops of wire 6 near the inflow end of the pipe body 1 at the docking section.

[0093] ② Following the route from the inflow end of the pipe body 1 to the outflow end of the pipe body 1, insert the needle into the joint and the pipe wall 101 of the pipe body 1, and then insert the needle out of the pipe body 1 and the joint. Repeat this operation until the pipe body 1 is sutured to the outflow end, forming the suture line 4 at the junction of the third leaf 203 and the second leaf 202, and the suture line 4 at the junction of the second leaf 202 and the first leaf 201, respectively.

[0094] (2) The suture line 4 of the inflow edge 302.

[0095] (3) Following the direction from the inflow end of the pipe body 1 to the outflow end of the pipe body 1, form the second row of stitching lines 4 at the joint. Following the operations in ① and ② above, form two more loops of stitching 6 at the outflow end of the joint.

[0096] (4) Suture 4 at the leaflet junction 303 (the suture 4 at the junction of the third leaflet 203 and the second leaflet 202, and the junction of the second leaflet 202 and the first leaflet 201, excluding the docking part).

[0097] (5) Locking line of inflow edge 302: At a radial distance of 0.5mm from the suture line 4, the needle is inserted into the inflow edge 302 and the pipe wall 101 of the pipe body 1, and then pulled out from the pipe wall 101 of the pipe body 1. The operation is repeated continuously to form the locking line 5.

[0098] The above steps (1)-(4) result in a single loop of suture 4. The number of suture 4 used in the above steps (1)-(3) is one. (4) The number of suture 4 used is two. (5) The number of sutures used is one.

[0099] The 10 pulmonary artery valved conduits obtained in Example 4 were subjected to hydrodynamic testing. The experimental results are shown in the table below:

[0100] Table 4: Hydrodynamic test results of the pulmonary artery valved conduit obtained in Example 4

[0101]

[0102] In Example 4, the pulmonary artery valved conduit obtained underwent 300 million durability tests without leaflet tearing, and the valve 2 of the pulmonary artery valved conduit functioned normally.

[0103] Example 5

[0104] The main difference between this embodiment and Embodiment 2 is that: Figure 9 As shown, valve 2 has a pre-drilled hole 305 for easy suturing. The pre-drilled hole 305 is located 1.2mm-1.3mm away from the inflow edge 302.

[0105] Ten pulmonary artery valved conduits obtained in Example 5 were subjected to hydrodynamic testing. The experimental results are shown in the table below:

[0106] Table 5: Hydrodynamic test results of the pulmonary artery valved conduit obtained in Example 5

[0107]

[0108] In Example 5, the pulmonary artery valved conduit obtained underwent 200 million durability tests without leaflet tearing, and the valve 2 of the pulmonary artery valved conduit functioned normally.

[0109] Example 6

[0110] The main difference between this embodiment and Embodiment 2 is that: Figure 10 As shown, valve 2 consists of three separate leaflets, each leaflet having two mating edges 301. During suturing, one mating edge 301 of the first leaflet 201 and one mating edge 301 of the second leaflet 202 overlap to form a mating part, one mating edge 301 of the second leaflet 202 and one mating edge 301 of the third leaflet 203 overlap to form a mating part, and one mating edge 301 of the third leaflet 203 overlaps with one mating edge 301 of the first leaflet 201 to form a mating part. The three mating parts and the inflow edge 302 are then fixed inside the tube body 1.

[0111] The 10 pulmonary artery valved conduits obtained in Example 6 were subjected to hydrodynamic testing. The experimental results are shown in the table below:

[0112] Table 6: Hydrodynamic test results of the pulmonary artery valved conduit obtained in Example 6

[0113]

[0114] The pulmonary artery valved conduit obtained in Example 6 suffered leaflet tearing after 230 million durability tests, and valve 2 of the pulmonary artery valved conduit failed after 250 million durability tests.

[0115] Example 7

[0116] The main difference between this embodiment and Embodiment 2 is that: Figure 11 As shown, valve 2 consists of three integrally connected leaflets, which form a cylindrical shape. Valve 2 includes a suture portion and an outflow edge 304. Valve 2 is divided into a first leaflet 201, a second leaflet 202, and a third leaflet 203 connected sequentially. The suture portion includes the inflow edge 302, the junction of the first leaflet 201 and the second leaflet 202, the junction of the second leaflet 202 and the third leaflet 203, and the junction of the third leaflet 203 and the first leaflet 201. Before suturing, the conduit body 1 is everted, and the suture portion of valve 2 is fixed to the inner wall of the conduit body 1 using sutures.

[0117] The 10 pulmonary artery valved conduits obtained in Example 7 were subjected to hydrodynamic testing. The experimental results are shown in the table below:

[0118] Table 7: Hydrodynamic test results of the pulmonary artery valved conduit obtained in Example 7

[0119]

[0120] The pulmonary artery valved conduit obtained in Example 7 suffered leaflet tearing after 250 million durability tests and valve 2 of the pulmonary artery valved conduit failed after 300 million durability tests.

[0121] Comparative Example 1

[0122] Compared to Example 2, in Comparative Example 1, the schematic diagram of the suture shape e formed by the suture 4 is shown below. Figure 13 As shown, the specific suturing method is as follows: Insert the needle into the inner wall of the valve 2 and the conduit body 1 to form the first needle hole 701, then insert it out from the tube wall 101 of the conduit body 1 to form the second needle hole 702, then insert the needle into the inner wall of the valve 2 and the conduit body 1 to form the third needle hole 703, and repeat the above suturing operation to fix the sutured part of the valve 2 to the inner wall of the conduit body 1.

[0123] Hydrodynamic tests were performed on the 10 pulmonary artery valved conduits obtained in Comparative Example 1. The experimental results are shown in the table below:

[0124] Table 8: Hydrodynamic test results of the pulmonary artery valved conduit obtained in Comparative Example 1

[0125]

[0126] The pulmonary artery valved conduit obtained in Comparative Example 1 experienced leaflet tearing after 100 million durability tests. Following leaflet tearing, the valve of the pulmonary artery valved conduit failed after 130 million durability tests. Compared to Comparative Example 1, the pulmonary artery valved conduits obtained in Examples 2-7 could withstand more than 200 million durability tests, exhibited a low leakage percentage, were less prone to leaflet tearing, and demonstrated excellent hemodynamics and durability.

[0127] The preferred embodiments of the present invention have been described in detail above. It should be understood that those skilled in the art can make numerous modifications and variations based on the concept of the present invention without creative effort. Therefore, all technical solutions that can be obtained by those skilled in the art based on the concept of the present invention through logical analysis, reasoning, or limited experimentation on the basis of existing technology should be within the scope of protection defined by the claims.

Claims

1. A pulmonary artery valved conduit, characterized in that, The device includes a tubular body and a valve. The valve is disposed on the inner wall of the tubular body. The valve includes at least one leaflet, and the leaflet has a suture portion. The suture portion is fixed to the inner wall of the tubular body by a suture. In at least a portion of the suture, some of the suture runs in the opposite direction to the suturing direction of the suture portion, and some of the suture runs in the same direction as the suturing direction of the suture portion. Sutures running in the same direction as the suturing direction of the suture portion and sutures running in the opposite direction as the suturing direction of the suture portion alternate. Furthermore, the stitch span of the suture running in the same direction as the suturing direction of the suture portion is greater than the stitch span of the suture running in the opposite direction as the suturing direction of the suture portion.

2. The pulmonary artery valved conduit according to claim 1, characterized in that, The stitch span of sutures in the same direction as the suture is between 2.0 mm and 3.0 mm, and the stitch span of sutures in the opposite direction to the suture is between 1.0 mm and 1.5 mm.

3. The pulmonary artery valved conduit according to claim 2, characterized in that, The stitch span of a suture line in the same direction as the suture is twice that of a suture line in the opposite direction to the suture.

4. The pulmonary artery valved conduit according to claim 2, characterized in that, The distance between two sutures that are opposite to the suturing direction of the suture section is less than or equal to the stitch span of the suture that is opposite to the suturing direction of the suture section.

5. The pulmonary artery valved conduit according to claim 1, characterized in that, The suture is a single loop.

6. The pulmonary artery valved conduit according to claim 1, characterized in that, The stitch span of the suture line that is opposite to the suturing direction of the suture section is located on the inner wall surface of the pipe body.

7. The pulmonary artery valved conduit according to claim 1, characterized in that, The number of petals is three, and the three petals are connected as a whole or by sutures.

8. The pulmonary artery valved conduit according to claim 1, characterized in that, The number of petals is one.

9. The pulmonary artery valved conduit according to claim 1, characterized in that, The leaflets are also fixed to the inner wall of the pipe body by locking lines and winding lines.

10. A method for suturing a valved pulmonary artery conduit as described in any one of claims 1-9, characterized in that, Includes the following steps: Step 1: Turn the pipe body outward so that the inner wall of the pipe body faces outward; Step 2: Lay out the valve leaflets and attach them to the predetermined position on the inner wall of the everted tube body; Step 3: Sew the seam to the inner wall of the pipe body with suture thread to form the shape required by any of claims 1-9; Step 4: After suturing, turn the tube back to the implanted position.

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