Valved conduit and method of forming

Abstract

The application discloses a kind of valve conduit and forming method, including artificial blood vessel formed by using biological material, the artificial blood vessel has sewing part for being sutured with artificial valve at one end;Artificial valve has sewing edge for being sutured with artificial blood vessel;Sewing part is covered and arranged on the upper surface of sewing edge from the outer edge of sewing edge to the root of sewing edge, and is sutured with sewing edge between sewing edge outer edge and root position respectively.Sewing part is conveniently realized conformal fit and covered arrangement on the surface of sewing edge by using the elasticity and flexibility of artificial blood vessel of biological material, and by being sutured with sewing edge and sewing part at the root of sewing edge and the outer edge of sewing edge respectively, not only solve the connection problem between artificial blood vessel of biological material and artificial valve, and the problem of leakage easily occurring at connection position is well solved.

Description

Technical Field

[0001] This invention belongs to the field of biomedical technology, specifically relating to a valved conduit and its molding method. Background Technology

[0002] A valved conduit is an artificial blood vessel with a valve. It typically consists of an artificial blood vessel and an artificial valve, used for simultaneous replacement of the ascending aorta and aortic valve. The artificial valve can be mechanical or bioprosthetic. The artificial blood vessel and the artificial valve are connected by sutures. The artificial blood vessel is usually made of woven fabric. The suture connection between the artificial blood vessel and the artificial valve is complex, the suturing operation is complicated, and leakage is prone to occur at the connection site. Summary of the Invention

[0003] The purpose of this invention is to provide a valved conduit and a molding method therefor, so as to realize the application of artificial blood vessels made of biomaterials in valved conduits.

[0004] This invention is achieved through the following technical solution:

[0005] Valved tubes, including:

[0006] An artificial blood vessel formed from biomaterials, wherein the artificial blood vessel has a suture portion at one end for suturing connection with an artificial valve;

[0007] Artificial valve, having a suture edge for suturing connection with an artificial blood vessel;

[0008] The suture portion covers the upper surface of the suture edge from the outer edge to the root of the suture edge, and is sutured to the suture edge at the outer edge and the root of the suture edge, respectively.

[0009] In some embodiments, the artificial blood vessel is a corrugated tube structure.

[0010] In some embodiments, a sinus is formed at one end of the artificial blood vessel, and the outer surface of the sinus is a continuous and smooth surface.

[0011] In some embodiments, one end of the artificial blood vessel is configured as a gradually increasing diameter section, and the suture portion is located at the end of the gradually increasing section. When the suture portion is covered and attached to the suture edge, the gradually increasing section forms the sinus.

[0012] In some embodiments, a double-threaded suture is used to suture the suture portion and the suture edge at the root of the suture edge.

[0013] In some embodiments, the artificial blood vessel is formed by suturing together sheet-like biomaterials.

[0014] In some embodiments, the biomaterial is a decellularized collagen matrix material.

[0015] On the other hand, the present invention also provides a method for forming a valved conduit, wherein the end of the suture portion located at one end of the artificial blood vessel is aligned with the outer edge of the suture edge of the artificial valve, and the suture portion and the suture edge are sutured together at the outer edge of the suture edge, wherein the artificial blood vessel is formed using biomaterials;

[0016] The suture portion is placed on the upper surface of the suture edge along the direction from the root of the suture edge, and then the suture portion is sutured to the suture edge at the root of the suture edge.

[0017] Compared with the prior art, the present invention has the following advantages and beneficial effects:

[0018] By utilizing the elasticity and flexibility of biomaterial-based artificial blood vessels, it is easy to achieve conformal fitting and covering of the suture portion on the suture edge surface. By suturing the suture edge and the suture portion together at the root and outer edge of the suture edge, the problem of connecting biomaterial-based artificial blood vessels and artificial valves is solved. The connection operation is much more convenient than that of artificial blood vessels made of fabric materials. Furthermore, this connection structure enables good sealing performance between the artificial blood vessel and artificial valve at the suture connection point, effectively solving the problem of leakage that is prone to occur at the connection point.

[0019] In the molding process of valved conduits, the suture portion is first connected at the outer edge of the suture margin to facilitate the subsequent neat wrapping and placement of the suture portion onto the suture margin surface. The suture portion is then extended along the suture margin surface to the root of the suture margin, aligning the suture portion with the root of the suture margin. Finally, the suturing operation is performed at the root of the suture margin. This makes the connection between the artificial blood vessel and the artificial valve more convenient, realizing the application of biomaterial artificial blood vessels in valved conduits. Attached Figure Description

[0020] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings in the embodiments will be briefly described below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0021] Figure 1 This is a schematic diagram of a valved pipe structure according to an embodiment of the present invention.

[0022] Figure 2 This is a schematic diagram of one embodiment of the artificial blood vessel in the valved conduit of the present invention.

[0023] Figure 3 This is a schematic diagram of the valved conduit implantation procedure according to an embodiment of the present invention.

[0024] Figure 4 This is a schematic diagram of the connection structure between the valve holder and the valved pipe in an embodiment of the present invention.

[0025] in:

[0026] 10. Artificial blood vessel; 101. Suture section; 102. Gradual transition section; 11. Sinus section; 12. Restraint ring;

[0027] 20. Artificial valve; 201. Suture edge; 211. Root of suture edge;

[0028] 30. Valve holder. Detailed Implementation

[0029] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are some embodiments of the present invention, but not all embodiments.

[0030] This invention relates to the application of artificial blood vessels made of biomaterials in valved conduits. One problem that needs to be solved in this application is how to achieve the connection between the artificial blood vessel and the artificial valve and ensure that no leakage occurs at the connection point.

[0031] In some embodiments of the present invention, the valved conduit includes an artificial blood vessel 10 made of biomaterials and an artificial valve 20.

[0032] The artificial blood vessel 10 is connected at one end to the suture edge 201 of the artificial valve. The connection method between the artificial blood vessel 10 and the suture edge 201 is as follows:

[0033] One end of the artificial blood vessel is wrapped around the upper surface of the suture edge from the outer edge to the root of the suture edge 211, and the artificial blood vessel and the suture edge are sutured together at the outer edge and the root of the suture edge, respectively.

[0034] For ease of description, the part on the artificial blood vessel used to suture and connect with the suture edge of the artificial valve is referred to as the suture part 101.

[0035] Artificial valves typically have a flange-shaped suture edge 201 on the valve seat, which can be used for connection with artificial blood vessels. The outer contour of the suture edge is called the outer edge of the suture edge, and the connection position between the suture edge and the valve seat is called the root of the suture edge 211.

[0036] The upper surface of the suture edge referred to here is the surface of the suture edge facing the side where the artificial blood vessel is located, or the side of the suture edge facing the side where the valve stent is placed.

[0037] Reference Figure 1 When connecting the artificial blood vessel and the artificial valve, align the end of the suture portion of the artificial blood vessel with the outer edge of the suture edge of the artificial valve, and suture the suture portion and the suture edge together at the outer edge of the suture edge.

[0038] Then, taking advantage of the flexibility and elasticity of the biomaterial, the suture portion is spread and placed on the upper surface of the suture edge towards the root of the suture edge, so that the suture portion covers the upper surface of the suture edge, and the suture portion is sutured to the suture edge at the root of the suture edge.

[0039] The connection method used between the artificial blood vessel and the artificial valve fully utilizes the elasticity and flexibility of the biomaterial artificial blood vessel, which can easily achieve conformal fitting and covering of the suture part on the suture edge surface. By suturing the suture edge and the suture part at the root and outer edge of the suture edge respectively, it not only solves the connection problem between the artificial blood vessel and the artificial valve, but also ensures good sealing performance at the suture connection point, effectively solving the problem of leakage that is prone to occur at the connection point.

[0040] In some embodiments, the artificial blood vessel 10 is a corrugated tube structure having alternating peaks and troughs.

[0041] Artificial blood vessels with corrugated tube structures formed using biomaterials can be formed using chemical fixation. For example, sheet-like biomaterials that have not been chemically fixed can be sewn into a tube shape, and then the artificial blood vessel can be shaped using chemical fixation to form a corrugated structure, thus obtaining an artificial blood vessel with a corrugated tube structure.

[0042] Alternatively, a physical connection molding method can be used. For example, after sewing sheet-like biomaterials into a tube, multiple spaced constraint rings 12 are formed by wrapping sutures around the tube body. The diameter of the constraint rings is smaller than the diameter of the tube body at the corresponding position. When the tube body is subjected to outward pressure and is in a bulging state, the constraint rings 12 can bind the tube body at the corresponding position, thereby forming troughs at the constraint ring positions and crests between the constraint rings, resulting in an artificial blood vessel with a corrugated tube structure.

[0043] In some embodiments, a sinus portion 11 is formed at one end of the artificial blood vessel 10, and the outer surface of the sinus portion 10 is a continuous and smooth surface.

[0044] The continuous smoothness of the outer surface of the sinus is not used to limit the surface roughness of the outer surface of the sinus, but rather to mean that there are no other structures on the outer surface of the sinus except for the connection structure when forming the artificial blood vessel. Or, taking the artificial blood vessel with a constraint ring set on the artificial blood vessel to form a corrugated tube structure as an example, no constraint ring is set in the sinus or the part of the artificial blood vessel where the sinus is formed, so that the surgeon can directly use a hole opener to open the sinus during clinical operation to achieve the connection between the valved conduit and the coronary artery.

[0045] The sinus can be formed directly during the formation of the artificial blood vessel, or it can be formed on the artificial blood vessel when the artificial blood vessel is sutured to the artificial valve.

[0046] Using the method of connecting the artificial blood vessel and the artificial valve in the embodiments of the present invention, a sinus is formed on the artificial blood vessel while suturing it to the artificial valve. The forming method can be as follows:

[0047] Reference Figure 2 A gradually increasing diameter transition section 102 is provided at one end of the artificial blood vessel 10, which is similar to a trumpet shape. At this time, the suture part 101 is located at the end of the transition section 102. The suture part is sutured to the suture edge at the outer edge and the root of the suture edge, respectively. The covering of the suture part on the upper surface of the suture edge and the connection at the root of the suture edge enable the transition section to form a drum-shaped sinus 11.

[0048] Typically, the main body of the suture edge is made of silicone, and the outside of the main body is covered with fabric. The suture connection at the root of the artificial blood vessel plays an important role in ensuring the airtightness of the two at the connection point. Therefore, double-thread sutures can be used at the suture edge root to increase the connection strength at this position and to effectively seal the needle holes formed on the artificial blood vessel, thereby solving the problem of leakage at the connection point.

[0049] Of course, other similar connection methods can be used at the suture base to achieve a good seal at the connection location.

[0050] The connection at the outer edge of the suture serves as an auxiliary connection between the artificial blood vessel and the artificial valve, and can be made using single or double sutures.

[0051] Artificial blood vessels can be formed by suturing sheet-like biomaterials. For example, sheet-like biomaterials can be rolled into a tube shape, and the two free ends of the sheet material can be aligned to form overlapping and outwardly protruding suture edges. These suture edges are then sutured together, resulting in a tube with a teardrop-shaped cross-section. This structural form of artificial blood vessel allows for a continuous transition of the inner wall at the suture site, resulting in better adhesion between the sutured portion and the suture edge when connecting the artificial blood vessel to an artificial valve.

[0052] Biomaterials used for molding artificial blood vessels can be decellularized collagen matrix materials, such as thin sheets of tissue like the pericardium of humans or animals, such as bovine pericardium.

[0053] Reference Figure 3 and Figure 4 The implantation of the valved conduit can be performed by connecting the artificial valve 20 with the valved conduit to the valve holder 30 with a suture, and then using the valve holder to insert the valved conduit into the implantation site.

[0054] By setting the connection method between the suture, the valve holder, and the artificial valve, after the valved conduit is implanted, the suture can be cut with a single cut to separate the valve holder from the artificial valve, which greatly facilitates the implantation of the valved conduit.

[0055] On the other hand, this embodiment of the invention also provides a method for forming a valved conduit, used to prepare a valved conduit for an artificial blood vessel using biomaterials, comprising:

[0056] Align the end of the suture portion located at one end of the artificial blood vessel with the outer edge of the suture edge of the artificial valve, and suture the suture portion 101 and the suture edge 201 together at the outer edge of the suture edge.

[0057] The suture portion is placed on the upper surface of the suture edge along the direction from the root 211 of the suture edge, and the suture portion 101 is sutured to the suture edge 201 at the root of the suture edge to prepare a valved conduit based on biomaterial artificial blood vessel.

[0058] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., used to indicate the orientation or positional relationship are based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship that the product of this invention is usually placed in during use. They are only for the convenience of describing this invention and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0059] Furthermore, the use of terms such as "horizontal" and "vertical" in the description of this invention does not imply that the components are required to be absolutely horizontal or suspended, but rather that they can be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal than "vertical," and does not mean that the structure must be completely horizontal, but can be slightly tilted.

[0060] In the description of this invention, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention in light of the specific circumstances.

[0061] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Any simple modifications or equivalent changes made to the above embodiments based on the technical essence of the present invention shall fall within the protection scope of the present invention.

Claims

1. A method for forming a valved pipe, characterized in that, The valved conduit includes: An artificial blood vessel formed from biomaterials, wherein the artificial blood vessel has a suture portion at one end for suturing connection with an artificial valve; Artificial valve, having a suture edge for suturing connection with an artificial blood vessel; Align the end of the suture portion at one end of the artificial blood vessel with the outer edge of the suture edge of the artificial valve, and suture the suture portion to the suture edge at the outer edge of the suture edge. The suture portion is placed on the upper surface of the suture edge along the direction from the root of the suture edge, and then the suture portion is sutured to the suture edge at the root of the suture edge.

2. The method for forming a valved pipe according to claim 1, characterized in that, The artificial blood vessel has a corrugated tube structure.

3. The method for forming a valved pipe according to claim 1 or 2, characterized in that, A sinus is formed at one end of the artificial blood vessel, and the outer surface of the sinus is a continuous and smooth surface.

4. The method for forming a valved pipe according to claim 3, characterized in that, One end of the artificial blood vessel is configured as a gradually increasing diameter section, and the suture portion is located at the end of the gradually increasing section. When the suture portion is covered and attached to the suture edge, the gradually increasing section forms the sinus.

5. The method for forming a valved pipe according to claim 1, characterized in that, Double-thread sutures are used to suture the suture portion and the suture edge at the base of the suture edge.

6. The method for forming a valved pipe according to claim 1, characterized in that, The artificial blood vessel is formed by suturing together sheet-like biomaterials.

7. The method for forming a valved pipe according to claim 1 or 6, characterized in that, The biomaterial is a decellularized collagen matrix material.

Images