Valved pipeline and forming method

Abstract

The invention discloses a valved pipeline and a forming method. The valved pipeline comprises an artificial blood vessel formed by adopting a biological material, and one end of the artificial blood vessel is provided with a suture part used for being in suture connection with an artificial valve; the artificial valve is provided with a suture edge used for being in suture connection with the artificial blood vessel; the suturing part is arranged on the upper surface of the suturing edge in a wrapping mode from the outer edge of the suturing edge to the root of the suturing edge, and the suturing part is connected with the suturing edge in a suturing mode at the outer edge of the suturing edge and the root of the suturing edge. By means of the elasticity and flexibility of the artificial blood vessel made of biological materials, shape follow-up attachment and wrapping arrangement of the suturing portion of the artificial blood vessel on the surface of the suturing edge are conveniently achieved, and the suturing edge and the suturing portion are sutured and connected at the root of the suturing edge and the outer edge of the suturing edge respectively. The problem of connection between the artificial blood vessel and the artificial valve made of biological materials is solved, and the problem that leakage is prone to occurring at the connection position is well solved.

Description

Technical Field

[0001] The invention belongs to the field of biomedical technology, and in particular relates to a valved pipe and a molding method thereof. Background Art

[0002] The valved conduit is an artificial blood vessel with a valve. The valved conduit usually includes an artificial blood vessel and an artificial valve, and is used for simultaneous replacement and implantation of the ascending aorta and aortic valves. The artificial valve can be a mechanical valve or a biological valve. The artificial blood vessel and the artificial valve are connected by suture. The artificial blood vessel is usually woven and formed with fabric materials. The sewing connection between the artificial blood vessel and the artificial valve has a complex structure and a complex sewing operation, and leakage is prone to occur at the connection position. Summary of the invention

[0003] The object of the present invention is to provide a valved conduit and a molding method to realize the application of an artificial blood vessel made of biomaterials in the valved conduit.

[0004] The present invention is achieved through the following technical solutions: Valved tube, including: An artificial blood vessel formed of biological material, wherein the artificial blood vessel has a suture portion at one end for suture connection with an artificial valve; An artificial valve having a suture edge for suture connection with an artificial blood vessel; The suture part is covered on the upper surface of the suture edge from the outer edge of the suture edge to the root of the suture edge, and is sutured and connected with the suture edge at the outer edge of the suture edge and the root of the suture edge respectively.

[0005] In some embodiments, the artificial blood vessel is a bellows structure.

[0006] In some embodiments, a sinus portion is formed at one end of the artificial blood vessel, and the outer surface of the sinus portion is a continuous and smooth surface.

[0007] In some embodiments, one end of the artificial blood vessel is configured as a gradient section with gradually increasing caliber, and the suture portion is located at the end of the gradient section. When the suture portion is covered on the upper surface of the suture edge and connected to the suture edge, the gradient section forms the sinus portion.

[0008] In some embodiments, a double-line suture is used at the root of the suture edge to suture the suture portion and the suture edge together.

[0009] In some embodiments, the artificial blood vessel is formed by suturing and connecting sheet-like biological materials.

[0010] In some embodiments, the biomaterial is a decellularized collagen matrix material.

[0011] On the other hand, the present invention also provides a method for forming a valved conduit, wherein the end of a suture portion located at one end of an artificial blood vessel is aligned with the outer edge of a suture edge of an artificial valve, and the suture portion is sutured and connected with the suture edge at the position of the outer edge of the suture edge, wherein the artificial blood vessel is formed by biomaterial; The sewing part is covered and arranged on the upper surface of the sewing edge along the upper surface of the sewing edge toward the root of the sewing edge, and the sewing part is sewn and connected with the sewing edge at the root of the sewing edge.

[0012] Compared with the prior art, the present invention has the following advantages and beneficial effects: By utilizing the elasticity and flexibility of the artificial blood vessels made of biomaterials, it is convenient to realize the conformal fitting and coating arrangement of the suture part of the artificial blood vessel on the surface of the suture edge, and by suturing the suture edge and the suture part at the root of the suture edge and the outer edge of the suture edge respectively, not only the connection problem between the artificial blood vessels made of biomaterials and the artificial valve is solved, but the connection operation between the two is more convenient than that of the artificial blood vessels made of fabric materials. In addition, through this connection structure, the artificial blood vessel and the artificial valve can have good sealing performance at the suture connection position, which well solves the problem of leakage that is easy to occur at the connection position.

[0013] In the molding operation of the valved conduit, the suture part is first connected at the outer edge of the suture edge to facilitate the subsequent operation of neatly wrapping the suture part on the surface of the suture edge, and the suture part is extended along the surface of the suture edge to the root of the suture edge, so that the suture part is aligned with the root of the suture edge at the root position of the suture edge, and then the suture operation is performed at the root position of the suture edge. The connection between the artificial blood vessel and the artificial valve is more convenient, realizing the application of artificial blood vessels made of biomaterials in valved conduits. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings in the embodiments will be briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without creative work.

[0015] Figure 1 This is a schematic diagram of the valved pipe structure according to an embodiment of the present invention.

[0016] Figure 2 This is a schematic structural diagram of an implementation scheme of an artificial blood vessel in a valved conduit according to an embodiment of the present invention.

[0017] Figure 3 This is a schematic diagram of the valved conduit implantation operation according to an embodiment of the present invention.

[0018] Figure 4Schematic diagram of the connection structure between the valve holder and the valved tube according to an embodiment of the present invention.

[0019] in: 10. artificial blood vessel, 101. suture portion, 102. gradient section, 11. sinus portion, 12. restraining ring; 20, artificial valve, 201, suture edge, 211, suture edge root; 30. Petal holder. DETAILED DESCRIPTION

[0020] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments.

[0021] The present invention is the application of artificial blood vessels made of biomaterials in valved conduits, so that artificial blood vessels made of biomaterials can be applied to valved conduits. One problem that needs to be solved in the application is how to achieve the connection between the artificial blood vessels and the artificial valves and ensure that no leakage occurs at the connection position between the two.

[0022] In some embodiments of the present invention, the valved conduit includes an artificial blood vessel 10 and an artificial valve 20 made of biological materials.

[0023] The artificial blood vessel 10 is connected to the suture edge 201 of the artificial valve at one end, and the connection method between the artificial blood vessel 10 and the suture edge 201 is: One end of the artificial blood vessel is covered on the upper surface of the suture edge from the outer edge of the suture edge to the root 211 of the suture edge, and the artificial blood vessel and the suture edge are sutured and connected at the outer edge of the suture edge and the root of the suture edge respectively.

[0024] For the convenience of description, the portion of the artificial blood vessel used for suturing and connecting with the suture edge of the artificial valve is referred to as the suture portion 101.

[0025] Usually, a suture edge 201 with a flange structure is provided on the valve seat of the artificial valve, which can be used for connection with the artificial blood vessel. The outer contour of the suture edge is called the suture edge outer edge, and the connection position between the suture edge and the valve seat is called the suture edge root 211.

[0026] 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 in other words, the side of the suture edge facing the side where the valve frame is set.

[0027] Reference Figure 1When 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 at the outer edge of the suture edge; Then, utilizing the flexibility and elasticity of the biomaterial, the suture portion is spread along the upper surface of the suture edge toward the root of the suture edge, so that the suture portion covers the upper surface of the suture edge, and is sutured and connected to the suture edge at the root of the suture edge.

[0028] The above-mentioned connection method adopted between the artificial blood vessel and the artificial valve makes full use of the elasticity and flexibility of the artificial blood vessel made of biomaterials, and can easily realize the conformal fitting and coating setting of the suture part on the surface of the suture edge, and by suturing the suture edge and the suture part at the root of the suture edge and the 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 enables the artificial blood vessel and the artificial valve to have good sealing performance at the suture connection position, which well solves the problem of leakage that is easy to occur at the connection position.

[0029] In some embodiments, the artificial blood vessel 10 is a corrugated tube structure having wave crests and wave troughs arranged at intervals.

[0030] An artificial blood vessel with a corrugated tube structure formed by using biological materials can be formed by chemical fixation. For example, after sewing the sheet-like biological material that has not been chemically fixed into a tube, the prepared artificial blood vessel is shaped by chemical fixation to form a corrugated structure on the artificial blood vessel, thereby obtaining an artificial blood vessel with a corrugated tube structure.

[0031] Alternatively, a physical connection forming method may be used. For example, after sewing the sheet-like biomaterial into a tube, sutures are wound around the tube body to form a plurality of spaced apart constraint rings 12, and the diameter of the constraint ring is made smaller than the diameter of the tube body at the corresponding position. When the inside of the tube body is subjected to outward pressure and the tube body is in an inflated state, the constraint ring 12 can restrain the tube body at the corresponding position, thereby forming a trough at the position of the constraint ring on the tube body, and a peak at the position between the constraint rings, thereby obtaining an artificial blood vessel with a corrugated tube structure.

[0032] 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.

[0033] The outer surface of the sinus is a continuous smooth surface and is not used to limit the surface roughness of the outer surface of the sinus, but means that there is no other structure on the outer surface of the sinus except the connecting structure when forming the artificial blood vessel, or taking the above-mentioned artificial blood vessel with a corrugated tube structure formed by setting a constraint ring on the artificial blood vessel as an example, no constraint ring is set in the sinus or the part where the sinus is formed on the artificial blood vessel, so that the surgeon can directly use a hole opener to make a hole in the sinus during clinical surgery to achieve the connection between the valved conduit and the coronary artery.

[0034] The sinus portion may be formed by directly molding an artificial blood vessel with the sinus portion when molding the blood vessel, or the sinus portion may be molded on the artificial blood vessel when the artificial blood vessel is sutured and connected to the artificial valve.

[0035] By using the method of connecting the artificial blood vessel and the artificial valve in the embodiment of the present invention, while suturing the artificial blood vessel to the artificial valve, a sinus portion is formed on the artificial blood vessel. The forming method that can be used is: Reference Figure 2 A gradual section 102 with a gradually increasing diameter is provided at one end of the artificial blood vessel 10, and the gradual section 102 is shaped like a trumpet; at this time, the suture portion 101 is located at the end of the gradual section 102, and the suture portion is sutured and connected with the suture edge at the outer edge of the suture edge and the root of the suture edge respectively, so that the covering setting of the suture portion on the upper surface of the suture edge and the connection at the root of the suture edge can make the gradual section form a drum-shaped sinus portion 11.

[0036] Usually, the main body of the suture edge is made of silicone material, and the outside of the main body is covered with fabric. The suture connection of the artificial blood vessel at the root of the suture edge plays an important role in ensuring the sealing of the two at the connection position. Therefore, the suture connection at the root of the suture edge can use double-line sutures, which can not only increase the connection strength at this position, but also effectively block the pinholes formed on the artificial blood vessel through the double-line sutures, thereby solving the problem of leakage at the connection position.

[0037] Of course, the suture connection at the root of the suture edge may also adopt other similar connection methods, so as to achieve good sealing at the connection position.

[0038] The connection at the outer edge of the suture edge serves as an auxiliary connection between the artificial blood vessel and the artificial valve, and can be connected by single-line or double-line sutures.

[0039] The artificial blood vessel can be formed by sewing a sheet of biological material, for example, by curling the sheet of biological material into a tube, aligning the two free ends of the sheet of material to form a stacked and outwardly protruding suture edge, and then sewing the suture edge, at this time, a tube body with a teardrop-shaped cross-section can be obtained. The artificial blood vessel of this structural form can form a continuous transition inner wall at the suture position inside the artificial blood vessel, so that when the artificial blood vessel is connected to the artificial valve, the suture part and the suture edge can form a better fit.

[0040] The biological material used for forming the artificial blood vessel can be a decellularized collagen matrix material, such as human or animal pericardium or other similar thin sheet tissue, such as bovine pericardium material.

[0041] Reference Figure 3 and Figure 4 The implantation operation of the valved conduit can be performed by connecting the artificial valve 20 of the valved conduit to the valve holder 30 through a binding wire, and then delivering the valved conduit to the implantation position through the valve holder.

[0042] By setting up a connection method between the binding wire, the valve holder and the artificial valve, after the implantation of the valved conduit is completed, the valve holder and the artificial valve can be separated by simply cutting the binding wire in a one-size-fits-all manner, which can greatly facilitate the implantation operation of the valved conduit.

[0043] On the other hand, an embodiment of the present invention further provides a valved conduit molding method for preparing a valved conduit of an artificial blood vessel using a biomaterial, comprising: 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 101 and the suture edge 201 at the position of the outer edge of the suture edge; The suture part is covered on the upper surface of the suture edge along the upper surface of the suture edge toward the root 211 of the suture edge, and the suture part 101 is sutured and connected with the suture edge 201 at the root of the suture edge to prepare a valved conduit based on a biomaterial artificial blood vessel.

[0044] In the description of the present invention, it should be noted that the terms "center", "up", "down", "left", "right", "vertical", "horizontal", "inside", "outside", etc. used to indicate the orientation or position relationship are based on the orientation or position relationship shown in the accompanying drawings, or are the orientation or position relationship commonly placed when the product of the invention is used. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0045] In addition, if the terms "horizontal" or "vertical" appear in the description of the present invention, it does not mean that the components are required to be absolutely horizontal or suspended, but can be slightly tilted. For example, "horizontal" only 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.

[0046] In the description of the present invention, it is also necessary to explain that, unless otherwise clearly specified and limited, the terms "set", "install", "connect", and "connect" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood in combination with specific circumstances.

[0047] The above description is only a preferred embodiment of the present invention and does not limit the present invention in any form. Any simple modification or equivalent change made to the above embodiment based on the technical essence of the present invention shall fall within the protection scope of the present invention.

Claims

1. A valved conduit, characterized in that: include: An artificial blood vessel formed of biological material, wherein the artificial blood vessel has a suture portion at one end for suture connection with an artificial valve; An artificial valve having a suture edge for suture connection with an artificial blood vessel; The suture part is covered on the upper surface of the suture edge from the outer edge of the suture edge to the root of the suture edge, and is sutured and connected with the suture edge at the outer edge of the suture edge and the root of the suture edge respectively.

2. The valved conduit according to claim 1, characterized in that: The artificial blood vessel is a bellows structure.

3. The valved conduit 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 valved conduit according to claim 3, characterized in that: One end of the artificial blood vessel is arranged as a gradual section with gradually increasing caliber, and the suture part is located at the end of the gradual section. When the suture part is covered on the upper surface of the suture edge and connected to the suture edge, the gradual section forms the sinus part.

5. The valved conduit according to claim 1, characterized in that: A double-thread suture is used at the root of the suture edge to suture and connect the suture portion and the suture edge.

6. The valved conduit according to claim 1, characterized in that: The artificial blood vessel is formed by suturing and connecting sheet-like biological materials.

7. The valved conduit according to claim 1 or 6, characterized in that: The biomaterial is a decellularized collagen matrix material.

8. A method for forming a valved pipe, characterized in that: Aligning 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 suturing the suture portion and the suture edge at the outer edge of the suture edge, wherein the artificial blood vessel is formed by biomaterial; The sewing part is covered and arranged on the upper surface of the sewing edge along the upper surface of the sewing edge toward the root of the sewing edge, and the sewing part is sewn and connected with the sewing edge at the root of the sewing edge.

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