CN109172041B

CN109172041B - Valved pipeline and preparation method thereof

Info

Publication number: CN109172041B
Application number: CN201811392458.0A
Authority: CN
Inventors: 赵益民
Original assignee: Hangzhou Chuangxin Medical Technology Co ltd
Current assignee: Hangzhou Chuangxin Medical Technology Co ltd
Priority date: 2018-11-21
Filing date: 2018-11-21
Publication date: 2024-03-12
Anticipated expiration: 2038-11-21
Also published as: CN109172041A

Abstract

The invention provides a valved conduit and a method of making the same, the valved conduit comprising: a conduit wall and valve structure; the valve structure is sewn on the pipeline wall to form at least two valve pockets; the first edge of the pipeline wall and the second edge of the pipeline wall are sewn together in a sewing mode that each needle is knotted to form a pipeline cavity; the at least two valve pockets are located in the pipeline cavity and are mutually overlapped. Therefore, the scheme provided by the invention can reduce the probability of opening the valved pipeline when trimming the valved pipeline.

Description

Valved pipeline and preparation method thereof

Technical Field

The invention relates to the technical field of medical instruments, in particular to a valved pipeline and a preparation method thereof.

Background

The valved conduit is a vascular prosthesis with a prosthetic valve and implantable in the body to replace a diseased vessel.

Currently, for patients suffering from heart disease, the diseased blood vessels are typically replaced with valved tubing. In the operation process, in order to accurately suture the valved conduit, a doctor needs to trim the conduit wall of the valved conduit so that the length and the shape of the valved conduit can meet the connection requirement. However, when trimming a valved conduit, there is a high probability that the suture line of the valved conduit will open.

Disclosure of Invention

The embodiment of the invention provides a valved pipeline and a preparation method thereof, which can reduce the probability of opening a line of the valved pipeline when trimming the valved pipeline.

In a first aspect, embodiments of the present invention provide a valved conduit comprising:

a conduit wall and valve structure;

the valve structure is sewn on the pipeline wall to form at least two valve pockets;

the first edge of the pipeline wall and the second edge of the pipeline wall are sewn together in a sewing mode that each needle is knotted to form a pipeline cavity;

the at least two valve pockets are located in the pipeline cavity and are mutually overlapped.

Preferably, the method comprises the steps of,

the first edge of the pipeline wall and the second edge of the pipeline wall are sewn together in a sewing mode that each needle is knotted to form a plurality of knotted sewing points; wherein each knotting seam point is provided with at least one fixed knot.

Preferably, the method comprises the steps of,

the sewing mode of tying a knot by each needle is as follows:

for any adjacent three of the knotted suture points, following the suture sequence of the three knotted suture points: the first suture line is knotted in a set knotting mode to form one fixed knot, and then penetrates into a second knotting suture point; then the first suture thread is threaded out from the first knotting suture point and knotted in the knotting mode to form a fixed knot; after the first suture line is knotted in the knotting mode to form a fixed knot, a third knotting suture point is penetrated; and then the first suture thread passes through the second suture point and is knotted in the knotting mode to form the fixed knot.

Preferably, the method comprises the steps of,

each knotting joint point corresponds to a pair of pipeline wall sewing marks respectively.

Preferably, the method comprises the steps of,

the valve structure is sutured on the pipeline wall in a valve suturing mode to form a plurality of valve suture points;

wherein, the valve suture mode is:

for any adjacent three of the valve commissures, following the sequence of the stitching of the three valve commissures: the second suture is threaded into the second valve suture point; the second suture thread then passes out of the first valve suture point; the second suture then penetrates a third valve suture point; the second suture is then threaded from the second valve suture site.

Preferably, the method comprises the steps of,

each valve suture point corresponds to a pair of valve suture identifiers.

In a second aspect, an embodiment of the present invention provides a method for manufacturing a valved conduit, the method comprising:

preparing a duct wall and a valve structure;

sewing the valve structure to the wall of the pipeline to form at least two valve pockets;

stitching the first edge of the pipeline wall and the second edge of the pipeline wall together in a stitching mode that each needle is tied into a knot to form a pipeline cavity; wherein, at least two lamella pockets are located in the pipeline chamber, and at least two lamella pockets overlap each other.

Preferably, the method comprises the steps of,

stitching the first edge of the pipeline wall and the second edge of the pipeline wall together in a stitching mode of tying one knot through each needle to form a plurality of knotting stitching points; wherein, each knotting joint point is respectively provided with at least one fixed knot;

the sewing mode of tying a knot by each needle is as follows:

Preferably, the method comprises the steps of,

before sewing the first edge of the conduit wall and the second edge of the conduit wall together by a stitch of one knot per needle, further comprising:

A plurality of pipeline wall stitching marks are respectively arranged on the first edge and the second edge; wherein the pipeline wall stitching identifications on the first edge correspond to the pipeline wall stitching identifications on the second edge one by one;

stitching the first edge of the conduit wall and the second edge of the conduit wall together by stitching one knot per needle, comprising:

and sewing the marks along the corresponding pipeline walls, and sewing the first edge of the pipeline walls and the second edge of the pipeline walls together by a sewing mode of tying one knot by each needle.

Preferably, the method comprises the steps of,

the suturing of the valve structure to the conduit wall comprises:

wherein, the valve suture mode is:

The embodiment of the invention provides a valved pipeline and a preparation method thereof. The first edge of the conduit wall and the second edge of the conduit wall are stitched together by stitching each stitch together to form a conduit lumen. The valve structure is sutured to the conduit wall to form two or more valve pockets. The valve pockets are overlapped with each other and are positioned in the pipeline cavity. From the above, the first edge and the second edge are stitched together by stitching one knot per needle in this embodiment. It can be seen that even when the valved conduit is trimmed, the valved conduit is not easily opened due to the action of the plurality of knotted suture points. Therefore, the scheme provided by the embodiment of the invention can reduce the probability of opening the valved pipeline when trimming the valved pipeline.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

FIG. 1 is a schematic view of a valved conduit according to one embodiment of the invention;

FIG. 2 is a top view of a valved conduit according to one embodiment of the invention;

FIG. 3 is a front view of a valved conduit according to one embodiment of the invention;

FIG. 4 is a schematic view of a valved conduit according to one embodiment of the invention in an expanded state;

FIG. 5 is a schematic illustration of a valve suturing method according to one embodiment of the present invention;

FIG. 6 is a schematic diagram of a knotting pattern provided in one embodiment of the present invention;

FIG. 7 is a schematic diagram of a suturing method for tying a knot per needle according to one embodiment of the present invention;

FIG. 8 is a flow chart of a method for preparing a valved conduit according to one embodiment of the present invention;

fig. 9 is a flowchart of a method for manufacturing a valved conduit according to another embodiment of the present invention.

Detailed Description

For the purpose of making the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention, and it is apparent that the described embodiments are some embodiments of the present invention, but not all embodiments, and all other embodiments obtained by those skilled in the art without making any inventive effort based on the embodiments of the present invention are within the scope of protection of the present invention.

As shown in fig. 1, an embodiment of the present invention provides a valved conduit including:

a conduit wall 101 and a valve structure 102;

the valve structure 102 is sewn on the duct wall 101 to form at least two valve pockets 103;

the first edge of the pipe wall 101 and the second edge of the pipe wall 101 are stitched together by stitching each stitch to form a pipe cavity 1011;

the at least two flap pockets 103 are positioned in the duct cavity 1011, and the at least two flap pockets 103 overlap each other.

According to the embodiment shown in fig. 1, the valved conduit includes a conduit wall and a valve structure therein. The first edge of the conduit wall and the second edge of the conduit wall are stitched together by stitching each stitch together to form a conduit lumen. The valve structure is sutured to the conduit wall to form two or more valve pockets. The valve pockets are overlapped with each other and are positioned in the pipeline cavity. From the above, the first edge and the second edge are stitched together by stitching one knot per needle in this embodiment. It can be seen that even when the valved conduit is trimmed, the valved conduit is not easily opened due to the action of the plurality of knotted suture points. Therefore, the scheme provided by the embodiment of the invention can reduce the probability of opening the valved pipeline when trimming the valved pipeline.

In one embodiment of the present invention, in the valved conduit shown in fig. 1 (which includes 3 pockets therein), the plurality of black spots on the outer surface of the valved conduit are the respective seam points formed when the valve structure is sewn to the conduit wall and the first and second edges of the conduit wall are sewn together.

In one embodiment of the invention, the number of pockets may be determined based on business requirements. For example, where the valved conduit is to be applied to a pulmonary artery, the number of valve pockets may be 3.

In this embodiment, the valved conduit will be described below taking 3 flap pockets as an example: as shown in fig. 2 and 3. Fig. 2 is a plan view of the valved conduit, and fig. 3 is a front view of the valved conduit (shown in cross-section in fig. 3). As can be seen from fig. 2 and 3, the duct wall 201 forms a duct chamber 2011. There are 3 pockets 2012A, 2012B, and 2012C in the tunnel chamber, and the edges a (free edges) of the three pockets overlap each other. The opening ends b of the 3 flap bags face in the same direction and are consistent with the axial direction of the pipeline cavity. When the valved conduit is applied to a human body, fluid (e.g., blood) in a human body vessel to which the valved conduit is connected is required to enter along a trajectory C from an a end of the valved conduit and exit from a B end of the valved conduit. When the valved conduit is applied to a human body, if the size and shape of the valved conduit cannot meet the application requirements, the conduit wall may be trimmed to make the size or shape of the valved conduit meet the application requirements.

In one embodiment of the invention, the valve structure may be sutured to the conduit wall by means of valve suturing and a plurality of valve suturing points are formed while the valve structure is sutured to the conduit wall.

In one embodiment of the invention, the plurality of valve commissures of the valved conduit includes a plurality of first valve commissures; combining the plurality of first valve suture points into at least two U-shaped valve pocket contours; wherein, each U-shaped valve pocket outline corresponds and forms a valve pocket.

In this embodiment, an example of fig. 4 is described as follows: fig. 4 is a schematic view of the valved conduit in an expanded state. It can be seen from fig. 4 that the valve structure 202 is sutured to the inner wall of the conduit wall 201 by a plurality of valve suturing points. Among the plurality of valve suture points is a plurality of first valve suture points 2031. The plurality of first valve suture points are combined into three U-shaped valve pocket outlines, and each U-shaped valve pocket outline corresponds to one valve pocket.

In this embodiment, the free edge a of each of the pockets is the same, and the relationship between the free edge length of each of the pockets and the radius of the lumen of the valved conduit satisfies the following formula (1):

wherein L represents the free edge length of the flap; r represents the radius of the pipeline cavity; pi characterizes the circumference ratio; n represents the total number of valve pockets in the valved conduit; k (k) ₁ Is the free edge coefficient.

In the present embodiment, the free edge coefficient k ₁ Can be used forAnd determining according to the service requirement. However, it should be noted that, in order to allow the free edges of the respective pockets to overlap each other, the free edge coefficient should be a value greater than 1.

In this embodiment, the pocket depth H of each flap pocket is uniform, and the relationship between the pocket depth H of each flap pocket and the radius of the tube cavity of the valved tube satisfies the following formula (2):

wherein H represents the pocket depth of the valve pocket; r represents the radius of the pipeline cavity; n represents the total number of valve pockets in the valved conduit; k (k) ₂ Is the pocket depth coefficient.

In the present embodiment, the pocket depth coefficient k ₂ May be determined according to the service requirements, for example may be 1.

In this embodiment, the total width of the material of which the valve structure is made may satisfy the following formula (3).

Wherein W represents the total width of the material for manufacturing the valve structure; n represents the total number of valve pockets in the valved conduit; l represents the free edge length of the flap;characterizing the stitching margin.

In this embodiment, the stitching margin may be determined according to business requirements. Such as determining the suture margin, it is necessary to fully consider the suture spacing requirements between the individual valve pockets and the width requirements of the suture area where the valve structure is sutured to the conduit wall.

According to the above embodiment, since the free edge length and pocket depth of each of the valved conduits are determined according to the conduit cavity radius of the valved conduits and the total number of the valved pockets. Therefore, the edges of the valve pockets can be mutually overlapped, and the liquid (such as blood) passing through the valve pockets can be ensured not to flow back to the greatest extent.

In one embodiment of the invention, the plurality of valve commissures further comprises a plurality of second valve commissures; the U-shaped bottom tangential lines of the outlines of the at least two U-shaped valve pockets are positioned on the same horizontal line; combining a plurality of second valve suture points into a valve structure fixing line; the valve structure fixing line is parallel to the horizontal line; the valve structure fixation wire sews the fixation edge of the valve structure to the conduit wall.

In this embodiment, as shown in fig. 4, a plurality of second valve commissures 2032 is also included in the plurality of valve commissures. The U-shaped bottom tangential lines of the outlines of the at least two U-shaped valve pockets are positioned on the same horizontal line S; the plurality of second valve suture points 2032 are combined into one valve structure fixation line V. The valve structure fixation line V is parallel to the horizontal line S. The valve structure fixing line is used for sewing the edge corresponding to the opening end of the valve pocket in the valve structure on the pipeline wall.

According to the above embodiments, since the valve suture points constituting the valve structure fixing thread are also included among the plurality of valve suture points. The edges of the valve structure are sutured to the duct wall by these valve suturing points. Thus, the valve structure is more firmly sewn to the duct wall, and the probability of sewing the suture lines of the flap pocket open is lower when liquid passing through the valved duct impinges the flap pocket.

In one embodiment of the invention, as shown in fig. 4, the valve structure further comprises two short sides 2021 to be sutured. When suturing a valve structure to a duct wall, there may be at least the following two suturing means for the two short sides to be sutured:

mode one: the two short sides to be sutured to the duct wall through a plurality of third valve suture points of the plurality of valve suture points;

mode two: the two short sides to be stitched are stitched to the duct wall by a plurality of knotted stitching points that stitch the first edge and the second edge. I.e. when the first edge and the second edge are sewn, both short sides to be sewn are sewn to the duct wall at the same time.

In one embodiment of the invention, the geometric center of the valve structure may coincide with the geometric center of the conduit wall when the valve structure is sutured to the conduit wall, such that there is a conduit wall of sufficient length at both the upper and lower ends of the valved conduit for trimming.

In one embodiment of the invention, when the selected valve structure and the pipeline wall have texture directions, the texture directions of the pipeline wall are parallel to the axis of the pipeline cavity; the grain direction of the valve structure is perpendicular to the grain direction of the duct wall.

In this embodiment, the texture orientation of the valve structure and the conduit wall is illustrated in fig. 4. It can be seen from fig. 4 that the direction of the texture E of the conduit wall coincides with the axial direction of the conduit lumen, whereas the direction of the texture F of the valve structure is perpendicular to the direction of the texture E of the conduit wall.

According to the above embodiment, the texture direction of the valve structure is perpendicular to the texture direction of the conduit wall, i.e. the texture direction of the valve structure is perpendicular to the flow direction of the liquid in the valved conduit. Thus, when the valved conduit is delivering liquid, impact damage to the valve structure caused by delivering liquid can be reduced.

In one embodiment of the invention, the valve suturing means may be:

In this embodiment, as shown in fig. 5, (the valve suture points M1, M2, M3, M4, M5, M6. included in fig. 5 are only one illustration, and do not represent the actual size and shape of the valve suture points). Only 6 valve suture points are shown in fig. 5, and any adjacent three valve suture points M3, M4, M5 among the 6 valve suture points are selected to explain the valve suture pattern. As can be seen in fig. 5, the suture is threaded into M4 first, then threaded out of M3, then threaded into M5, and then threaded out of M4.

In this embodiment, the type of the suture may be selected according to the service requirement. It should be noted that a suture thread with high strength and less breakage is required.

According to the above embodiments, when the valve structure is sutured to the duct wall, the suture loops around the adjacent three valve suture points. Thus, the valve structure may be more firmly sutured to the duct wall.

In one embodiment of the invention, the plurality of valve sutures may include a plurality of knotted valve sutures, each of which has at least one respective valve fixation knot.

In this embodiment, for example, at least one knotted valve seam point can be included in any adjacent three valve seam points;

The second suture is knotted to form at least one valve fixation knot in a set valve knotting manner at a position of penetrating or penetrating through each knotting valve suture point.

In this embodiment, it may be determined which valve suture point is the knotted valve suture point according to the service requirement. For example, all valve sutures may be provided as knotted valve sutures; a portion of the valve commissures may also be configured to knot the valve commissures.

For example, three adjacent valve commissures M3, M4, M5 are also illustrated: the three valve suture points M3, M4, M5 are all knotted valve suture points, and are all knotted in a set valve knotting manner at the position of the suture thread penetrating the knotted valve suture points to form a valve fixing point (black dots are used for indicating knots in fig. 5).

In this embodiment, in fig. 5, the G side represents the outer wall surface of the flap duct and the D side represents the duct chamber. It can be seen from fig. 5 that the valve fixation points of the knotted valve commissures are all located on the outer wall surface G of the valved conduit and not in the conduit lumen D. Since the location of the valve fixation point is on the outer wall surface G of the valved conduit, the wall surface within the conduit lumen D may be smoothed, thereby reducing the resistance to flow of liquid in the conduit lumen.

Of course, the valve fixation points may also all be located in the lumen of the conduit. Or the position of the valve fixing point of the knotted valve suture point is on the outer wall surface of the valved pipeline, and the position of the valve fixing point of the knotted valve suture point is in the pipeline cavity. However, neither of the above two methods is preferable.

In this embodiment, the pattern of the valve fixation knot may be determined according to the business requirements. For example, any one of a single knot, a square knot, a triple knot, a surgical knot may be used. For example, a single junction as shown in fig. 6 may be selected.

According to the above embodiments, the plurality of valve commissures may be partially or wholly knotted when the valve structure is sutured to the duct wall. Thus, the valve structure can be more firmly locked and sutured to the duct wall.

In one embodiment of the invention, each of the valve suture points corresponds to a respective pair of valve suture markers.

In this embodiment, one of the pair of valve suture markers is located in the valve structure and one is located in the conduit wall.

In this embodiment, the plurality of valve suture markers in the valve structure comprise at least two U-shaped positioning profiles. The plurality of valve suture markers in the conduit wall also comprise at least two U-shaped positioning profiles. Suture markers in the valve structure and the conduit wall that have correspondence overlap each other. The suture then sews the valve structure into the conduit wall along each pair of overlapping valve suture markers, forming at least two valve pockets.

In this embodiment, the method for setting the valve suture marker may be determined according to the service requirement. For example, the arrangement can be made by means of laser drilling. Here laser drilling is simply marking the valve structure or duct wall without penetrating it.

In this embodiment, the shape and size of the valve suture markers and the distance between each adjacent suture markers may be determined according to the service requirements. For example, the flap pocket stitching markers may be circular stitching markers having a radius of 0.03 mm and a distance between any two adjacent stitching marker points of 1 mm to 2 mm.

In this embodiment, the distance between any adjacent two suture identification points satisfies the following formula (4) for determination. Such as:

c represents the distance between two adjacent stitching identification points; k (k) ₃ Characterizing a width coefficient; beta represents the material coefficient of the pipeline wall; p represents the maximum pressure of the liquid transmitted by the valved pipeline; ρ represents the density of the valved conduit input liquid; q represents the maximum flow rate of the liquid transmitted by the valved pipeline; pi characterizes the circumference ratio; r represents the radius of the pipe cavity.

In this embodiment, the width coefficient may be determined according to the service requirement.

According to the above embodiment, since each valve sewing point corresponds to a pair of valve sewing marks, respectively. Therefore, when the valve structure is sutured on the wall of the pipeline, the valve structure can be sutured according to the valve suturing mark, so that the suture position is more accurate, and the suture efficiency is higher.

In one embodiment of the invention, each of the valve suture points corresponds to a respective one of the valve suture markers.

In this embodiment, each valve suture tag may be located entirely within the valve structure or each valve suture tag may be located entirely within the conduit wall.

In one embodiment of the present invention, the first edge of the pipe wall and the second edge of the pipe wall are sewn together by sewing the knots of each needle to form a plurality of knotted sewing points; wherein each knotting seam point is provided with at least one fixed knot.

In this embodiment, when the first edge of the duct wall and the second edge of the duct wall are sewn together by stitching one knot with each needle, it is necessary to overlap the first edge and the second edge to form a stitching region, and stitch the first edge and the second edge in the stitching region.

In this embodiment, the width of the overlapping between the first edge and the second edge may be determined according to the service requirement. The preferred overlap width may be 1.5 mm to 2.5 mm.

In this embodiment, at least one suture line may be included in the suture region, wherein each suture line may include a plurality of knotted suture points therein.

In one embodiment of the present invention, the stitching mode of tying a knot with each needle is as follows:

for any adjacent three of the knotted suture points, following the suture sequence of the three knotted suture points: for any adjacent three of the knotted suture points, following the suture sequence of the three knotted suture points: the first suture line is knotted in a set knotting mode to form one fixed knot, and then penetrates into a second knotting suture point; then the first suture thread is threaded out from the first knotting suture point and knotted in the knotting mode to form a fixed knot; after the first suture line is knotted in the knotting mode to form a fixed knot, a third knotting suture point is penetrated; and then the first suture thread passes through the second suture point and is knotted in the knotting mode to form the fixed knot.

In this embodiment, as shown in fig. 7, (the knotting points N1, N2, N3, N4, N5, N6. included in fig. 7 are only one illustration, and do not represent the actual size and shape of the knotting points). Fig. 7 shows only 6 knotting points, and the knotting method is described by selecting any adjacent three knotting points N3, N4, and N5 among the 6 knotting points. As can be seen from fig. 7, the suture is tied in a set knot manner to form a fixed knot (the black dots in fig. 7 are used to represent the fixed knot), and then is threaded into the knotted suture point N4; then the suture thread is threaded out from the knotting suture point N3, and is knotted in a knotting mode to form the fixed knot; then the suture is knotted in a knotting mode to form a fixed knot, and then the fixed knot is penetrated into a knotting suture point N5; the suture thread is then threaded out of the knotting suture point N4 and knotted in a knotting manner to form a fixed knot.

In this embodiment, in fig. 7, the G side represents the outer wall surface of the flap duct and the D side represents the duct chamber. It can be seen from fig. 7 that the fixing knots of the knotting seam points are all located on the outer wall surface of the valved duct and not in the duct cavity. The fixing knot is positioned on the outer wall surface of the valved pipeline, so that the wall surface in the pipeline cavity can be smooth, and the resistance of liquid flowing in the pipeline cavity is reduced.

Of course, the positions of the fixing knots of the knotting seam points can also be all located in the pipeline cavity. Or the position of the fixed knot of the part of knotted valve suture points in the knotted suture points is on the outer wall surface of the valved pipeline, and the position of the fixed knot of the other knotted suture points is in the pipeline cavity. However, neither of the above two methods is preferable.

In this embodiment, the type of the fixed knot may be determined according to the service requirement. For example, any one of a single knot, a square knot, a triple knot, a surgical knot may be used. For example, a single junction as shown in fig. 6 may be selected.

According to the above embodiment, when the first edge and the second edge of the duct wall are sewn, the sewing thread is sewn by sewing one knot per needle for any adjacent three knotted sewing points. Therefore, not only can the suture be more firmly performed, but also the valved conduit is not easy to open even if the valved conduit is trimmed under the action of a plurality of knotted suture points.

In one embodiment of the invention, each of the knotting seam points corresponds to a respective pair of the tunnel wall seam markers.

In this embodiment, one of the pair of conduit wall seam markers is located in a first edge of the conduit wall and one is located in a second edge of the conduit wall. The plurality of conduit wall seam markers in the first edge may comprise at least one seam line. The plurality of conduit wall seam markers in the second edge may form at least one seam line. The stitching marks with corresponding relation in the first edge and the second edge are mutually overlapped, and the stitching marks of the stitching lines of the pipeline walls are overlapped along the line to stitch the pipeline walls to form the pipeline cavity.

The multiple duct wall stitching identifications in the first edge form stitching lines e1 and f1, as described below with reference to fig. 4. The plurality of duct wall stitching identifications in the second edge form stitching lines e2 and f2. When the first edge of the pipeline wall and the second edge of the pipeline wall are stitched together through a plurality of continuous knotted stitching points, the pipeline wall is curled, so that the first edge and the second edge are overlapped, and after the first edge and the second edge are overlapped in stitching, each pair of pipeline wall stitching marks overlapped along the line of the stitching lines stitch the pipeline wall to form a pipeline cavity.

In this embodiment, the method, shape and size of the method for disposing the suture marker on the wall of the duct are the same as those of the method for disposing the suture marker on the valve, and will not be described in detail here.

In this embodiment, the distance between adjacent two of the duct wall suture identification points may be determined according to the following formula (4).

According to the embodiment, each knotted sewing point corresponds to a pair of pipeline wall sewing marks. Therefore, when the first edge and the second edge of the pipeline wall are stitched, stitching can be performed according to the pipeline wall stitching mark, so that the first edge and the second edge can be positioned more accurately during stitching, and the stitching efficiency is higher.

In one embodiment of the present invention, each of the knotting seam points corresponds to a respective one of the tunnel wall seam markers.

In this embodiment, each duct wall stitch signature may be disposed entirely within the first edge, or each duct wall stitch signature may be disposed entirely within the second edge.

In one embodiment of the invention, the material of the wall of the conduit and the valve structure can be determined according to the service requirements. For example, the material of the wall of the pipeline can be the pericardium of an animal. The valve structure can also be made of animal pericardium. Wherein, animal pericardium can be: any one of bovine pericardium, equine pericardium, porcine pericardium, ovine pericardium, donkey pericardium and mule pericardium.

According to the embodiment, since the wall of the pipeline and the valve structure are made of animal pericardium materials with antigen removed, the probability of rejection reaction of a human body can be reduced when the valved pipeline is applied to the human body.

As shown in fig. 8, an embodiment of the present invention provides a method for manufacturing a valved conduit, which may include the following steps:

step 801: preparing a duct wall and a valve structure;

step 802: sewing the valve structure to the wall of the pipeline to form at least two valve pockets;

step 803: stitching the first edge of the pipeline wall and the second edge of the pipeline wall together in a stitching mode that each needle is tied into a knot to form a pipeline cavity; wherein, at least two lamella pockets are located in the pipeline chamber, and at least two lamella pockets overlap each other.

According to the embodiment shown in fig. 8, the valve structure is first sewn to the duct wall to form two or more valve pockets. And then the first edge of the prepared pipeline wall and the second edge of the pipeline wall are sewn together in a sewing mode that each needle is tied into a knot to form a pipeline cavity. And each flap pocket is positioned in the lumen of the duct with each flap pocket overlapping each other. From the above, the first edge and the second edge are stitched together by stitching one knot per needle in this embodiment. It can be seen that even when the valved conduit is trimmed, the valved conduit is not easily opened due to the action of the plurality of knotted suture points. Therefore, the scheme provided by the embodiment of the invention can reduce the probability of opening the valved pipeline when trimming the valved pipeline.

In one embodiment of the present invention, a plurality of knotting seams are formed by stitching together the first edge of the pipe wall and the second edge of the pipe wall by each of the needles; wherein, each knotting joint point is respectively provided with at least one fixed knot;

the stitching manner of tying a knot for each needle referred to in the flowchart shown in fig. 8 may be:

for any adjacent three of the knotted suture points, following the suture sequence of the three knotted suture points: the first suture line is knotted in a set knotting mode to form a fixed knot, and then a second knotting suture point is penetrated; then the first suture thread is threaded out from the first knotting suture point and knotted in the knotting mode to form a fixed knot; after the first suture line is knotted in the knotting mode to form a fixed knot, a third knotting suture point is penetrated; and then the first suture thread passes through the second suture point and is knotted in the knotting mode to form the fixed knot.

In one embodiment of the present invention, the fixation knot referred to in the previous embodiment may be any one of a single knot, a square knot, a triple knot, and a surgical knot.

In one embodiment of the present invention, before the first edge of the pipe wall and the second edge of the pipe wall are sewn together by stitching with each needle, in step 803 in the flowchart shown in fig. 8, the method may further include:

step 803 of the flowchart of fig. 8, where the first edge of the pipe wall and the second edge of the pipe wall are stitched together by stitching one knot with each needle, may include:

In one embodiment of the present invention, the suturing of the valve structure to the wall of the conduit at step 802 of the flowchart of fig. 8 may include:

Wherein, the valve suture mode is:

In one embodiment of the invention, the plurality of valve commissures includes a plurality of knotted valve commissures; at least one valve fixation knot is present for each of the knotted valve seam points.

In one embodiment of the invention, the valve fixation knot comprises any one of a single knot, a square knot, a triple knot, a surgical knot.

In one embodiment of the invention, the plurality of valve commissures further comprises a plurality of second valve commissures; the U-shaped bottom tangential lines of the outlines of the at least two U-shaped valve pockets are positioned on the same horizontal line;

the method for preparing the valved conduit further comprises:

suturing the fixed edge of the valve structure to the conduit wall with a plurality of second valve suturing points; wherein the plurality of second valve suture points are combined into one valve structure fixing line, and the valve structure fixing line is parallel to the horizontal line.

In one embodiment of the invention, the method for preparing the valved conduit further comprises:

determining a direction of texture of a wall of a conduit and determining a direction of texture of the valve structure;

when the first edge and the second edge are stitched, the texture direction of the pipeline wall is parallel to the axis of the pipeline cavity;

when the valve structure is sutured on the duct wall, the texture direction of the valve structure is perpendicular to the texture direction of the duct wall.

In one embodiment of the present invention, the material of the wall of the conduit may be the pericardium of an animal. Wherein, animal pericardium can be: any one of bovine pericardium, equine pericardium, porcine pericardium, ovine pericardium, donkey pericardium and mule pericardium.

In one embodiment of the present invention, the valve structure may also be made of animal pericardium. Wherein, animal pericardium can be: any one of bovine pericardium, equine pericardium, porcine pericardium, ovine pericardium, donkey pericardium and mule pericardium.

A valved conduit including 3 valve pockets is prepared as an example below. The method for preparing the valved conduit is described in the open, as shown in fig. 9, and may comprise the steps of:

step 901: the duct wall and valve structure were prepared.

In this step, the vessel wall and valve structure are prepared using bovine pericardium.

Step 902: the axial direction of the pipe cavity is determined.

In this step, the axial orientation of the conduit chamber is determined.

Step 903: the direction of the texture of the conduit wall and valve structure is determined.

Step 904: the suturing pattern of each needle to form a knot is determined.

Step 905: the first edge and the second edge are determined according to the axis direction and the texture direction of the pipe wall.

In this step, the edge line of the first edge and the edge line of the second edge of the duct wall are parallel to the axis of the duct cavity; the grain direction of the duct wall is also parallel to the axis of the duct cavity.

Step 906: a plurality of valve seam markers are disposed in the conduit wall, and a plurality of conduit wall seam markers are disposed at the first and second edges thereof.

In this step, the valve seam markers and the conduit wall seam markers may be provided on the conduit wall by means of laser drilling.

In this step, the plurality of duct wall stitching identifications in the first edge may form at least one stitching line. The plurality of conduit wall seam markers in the second edge may form at least one seam line. And each conduit wall seam identification in the first edge has a corresponding conduit wall seam identification in the second edge.

In this step, the plurality of valve suture markers in the conduit wall constitute three U-shaped positioning profiles.

In this step, the distance between each two suture identifications can be determined according to formula (4).

Step 907: a plurality of valve suture markers are arranged in the valve structure according to the texture mode of the valve structure.

In this step, a plurality of valve suture markers in the valve structure make up three U-shaped positioning profiles. Wherein each valve suture indicator in the valve structure has a corresponding valve suture indicator in the conduit wall, respectively. When the valve suture mark is set, the free edge length of the valve pocket and the pocket depth of the valve pocket can be calculated according to the formula (1) and the formula (2), and then the position of the valve suture mark is determined according to the calculated free edge length of the valve pocket and the pocket depth of the valve pocket.

Step 908: and sewing the valve structure on the pipeline wall in a valve sewing mode according to the valve sewing marks to form at least two valve pockets.

In this step, the suture markers in correspondence in the valve structure and the duct wall are overlapped with each other. The sutures then stitch the valve structure into the conduit wall along each pair of overlapping valve suture markers to form three pockets. The opening ends of the flap bags are all in the same direction, and the same direction is consistent with the axial direction of the pipeline cavity.

In this step, the valve suturing procedure described above (as shown in fig. 5) may be used for suturing.

Step 909: according to the suturing marks of the pipeline walls, a first edge of the pipeline wall and a second edge of the pipeline wall are sutured together in a suturing mode that each needle is tied with a knot, so that a pipeline cavity is formed; wherein, at least two valve pockets are arranged in the pipeline cavity, and the at least two valve pockets are mutually overlapped.

In this step, the duct wall is curled such that the first edge overlaps the second edge. The stitching marks with corresponding relations in the first edge and the second edge are mutually overlapped, and each pair of pipeline wall stitching marks with stitching lines overlapped along the line stitch the pipeline wall to form a pipeline cavity. In the duct cavity, three flap pockets overlap each other.

In this step, the suturing may be performed by tying a knot with each needle as described above (as shown in fig. 7).

In summary, the following beneficial effects may be at least achieved by the embodiments of the present invention:

1. in an embodiment of the invention, the valved conduit includes a conduit wall and a valve structure therein. The first edge of the conduit wall and the second edge of the conduit wall are stitched together by stitching each stitch together to form a conduit lumen. The valve structure is sutured to the conduit wall to form two or more valve pockets. The valve pockets are overlapped with each other and are positioned in the pipeline cavity. From the above, the first edge and the second edge are stitched together by stitching one knot per needle in this embodiment. It can be seen that even when the valved conduit is trimmed, the valved conduit is not easily opened due to the action of the plurality of knotted suture points. Therefore, the scheme provided by the embodiment of the invention can reduce the probability of opening the valved pipeline when trimming the valved pipeline.

2. In embodiments of the present invention, since the valve suture points that constitute the valve structure fixation line are also included among the plurality of valve suture points, the edges of the valve structure are sutured to the duct wall by these valve suture points. Thus, the valve structure is more firmly sewn to the duct wall, and the probability of sewing the suture lines of the flap pocket open is lower when liquid passing through the valved duct impinges the flap pocket.

3. In the embodiment of the invention, the free edge length and the pocket depth of each valve pocket in the valve-bearing pipeline are determined according to the pipeline cavity radius of the valve-bearing pipeline and the total number of the valve pockets. Therefore, the edges of the valve pockets can be mutually overlapped, and the liquid (such as blood) passing through the valve pockets can be ensured not to flow back to the greatest extent.

4. In embodiments of the present invention, the plurality of valve commissures further comprises valve commissures that form a fixation line of the valve structure. The edges of the valve structure are sutured to the duct wall by these valve suturing points. Thus, the valve structure is more firmly sewn to the duct wall, and the probability of sewing the suture lines of the flap pocket open is lower when liquid passing through the valved duct impinges the flap pocket.

5. In the embodiment of the invention, the texture direction of the valve structure is perpendicular to the texture direction of the pipeline wall, namely, the texture direction of the valve structure is perpendicular to the flow direction of liquid in the valved pipeline. Thus, when the valved conduit is delivering liquid, impact damage to the valve structure caused by delivering liquid can be reduced.

6. In embodiments of the present invention, when the valve structure is sutured to the conduit wall, the suture loops around the adjacent three valve suture points. Thus, the valve structure may be more firmly sutured to the duct wall.

7. In embodiments of the present invention, the plurality of valve commissures may be partially or fully knotted when the valve structure is sutured to the wall of the conduit. Thus, the valve structure can be more firmly locked and sutured to the duct wall.

8. In the embodiment of the invention, each valve suture point corresponds to a pair of valve suture marks. Therefore, when the valve structure is sutured on the wall of the pipeline, the valve structure can be sutured according to the valve suturing mark, so that the suture position is more accurate, and the suture efficiency is higher.

9. In the embodiment of the invention, when the first edge and the second edge of the pipeline wall are sewn, the suture is sewn by adopting a sewing mode of tying one knot for each needle aiming at any adjacent three knotting sewing points. Therefore, not only can the suture be more firmly performed, but also the valved conduit is not easy to open even if the valved conduit is trimmed under the action of a plurality of knotted suture points.

10. In the embodiment of the invention, each knotted sewing point corresponds to a pair of pipeline wall sewing marks respectively. Therefore, when the first edge and the second edge of the pipeline wall are stitched, stitching can be performed according to the pipeline wall stitching mark, so that the first edge and the second edge can be positioned more accurately during stitching, and the stitching efficiency is higher.

11. In the embodiment of the invention, the wall of the pipeline and the valve structure are made of animal pericardium materials, so that the probability of rejection reaction of a human body can be reduced when the valved pipeline is applied to the human body.

It is noted that relational terms such as first and second, and the like, are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Moreover, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the statement "comprises one" does not exclude that an additional identical element is present in a process, method, article or apparatus that comprises the element.

Finally, it should be noted that: the foregoing description is only illustrative of the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention are included in the protection scope of the present invention.

Claims

1. A valved conduit comprising:

a conduit wall and valve structure;

the at least two valve pockets are positioned in the pipeline cavity and are mutually overlapped;

wherein the plurality of valve commissures of the valve conduit comprises a plurality of first valve commissures; combining the plurality of first valve suture points into at least two U-shaped valve pocket contours; wherein, each U-shaped valve pocket outline corresponds to form a valve pocket, and a plurality of valve suture points also comprise a plurality of second valve suture points; the U-shaped bottom tangential lines of the outlines of the at least two U-shaped valve pockets are positioned on the same horizontal line; combining a plurality of second valve suture points into a valve structure fixing line; the valve structure fixing line is parallel to the horizontal line; the valve structure fixing line is used for sewing the fixing edge of the valve structure on the pipeline wall;

The first edge of the pipeline wall and the second edge of the pipeline wall are sewn together in a sewing mode that each needle is knotted to form a plurality of knotted sewing points; wherein, each knotting joint point is respectively provided with at least one fixed knot;

the sewing mode of tying a knot by each needle is as follows:

2. The valved conduit according to claim 1,

3. The valved conduit according to claim 1,

wherein, the valve suture mode is:

4. The valved conduit according to claim 3,

each valve suture point corresponds to a pair of valve suture identifiers.

5. A method of making a valved conduit comprising:

preparing a duct wall and a valve structure;

stitching the first edge of the pipeline wall and the second edge of the pipeline wall together in a stitching mode that each needle is tied into a knot to form a pipeline cavity; wherein the at least two valve pockets are positioned in the pipeline cavity and are mutually overlapped;

the sewing mode of tying a knot by each needle is as follows:

6. The method of claim 5, wherein the step of determining the position of the probe is performed,

7. The method of claim 5, wherein the step of determining the position of the probe is performed,

the suturing of the valve structure to the conduit wall comprises:

wherein, the valve suture mode is: