Vascular prosthesis, valved conduit, and preparation method therefor

Abstract

Disclosed are a vascular prosthesis, a valved conduit, and a preparation method therefor. An elastic sealing layer is arranged at a suture part of the vascular prosthesis. When a suture line is adopted to suture and connect the vascular prosthesis with another part at the suture part, a needle hole formed in the vascular prosthesis during the suture operation can be blocked by the sealing layer due to the elasticity of the sealing layer and the acting force generated by the suture line on the sealing layer. By arranging the sealing layer with certain elasticity at the suture part of the vascular prosthesis, and by utilizing the elasticity of the sealing layer, the acting force generated by the suture line on the sealing layer, and the sealing performance of a sealing layer material, the needle hole formed in the vascular prosthesis during the suture operation can be blocked by the sealing layer, thereby solving the problem well that when the vascular prosthesis made of a fabric material is subjected to suture operation, leakage is prone to occurring at the suture part.

Description

Artificial blood vessel, valved conduit and preparation method thereof Technical Field

[0001] The present invention belongs to the field of biomedical technology, and in particular relates to an artificial blood vessel, a valved conduit and a preparation method thereof. Background Art

[0002] A valved conduit is a prosthetic blood vessel with a valve. It typically includes both a prosthetic blood vessel and a prosthetic valve, and is used for simultaneous replacement of both the ascending aorta and the aortic valve. The prosthetic valve can be mechanical or biological, and the prosthetic blood vessel is typically made of fabric. The prosthetic blood vessel and prosthetic valve are sutured together. However, implanting such a valved conduit in the human body can lead to significant bleeding and leakage.

[0003] Summary of the Invention

[0004] The purpose of the present invention is to provide an artificial blood vessel, a valved conduit and a preparation method thereof, so as to solve the problem of large bleeding and leakage at the suture position between the artificial blood vessel and the valved conduit when the valved conduit is implanted.

[0005] The present invention is achieved through the following technical solutions:

[0006] An artificial blood vessel is provided with an elastic bridging layer at its suture portion. When the artificial blood vessel is sutured to another component at the suture portion using sutures, the elasticity of the bridging layer and the force exerted by the sutures on the bridging layer are utilized to enable the bridging layer to seal pinholes formed on the bridging layer and the artificial blood vessel during the suturing operation.

[0007] In some embodiments, the bridging layer is obtained by coating a high molecular polymer material on the outer surface of the artificial blood vessel suture part.

[0008] In some embodiments, the bridging layer is a ring that is sleeved on the outer surface of the suture part of the artificial blood vessel, and the ring is formed of a high molecular polymer material.

[0009] In some embodiments, the thickness of the bridging layer at the corresponding suture position is not less than 0.2 mm.

[0010] In some embodiments, when the suture portion of the artificial blood vessel is a corrugated structure, the bridging layer is located at the trough of the corrugated structure.

[0011] In some embodiments, the high molecular polymer material is silica gel.

[0012] In another aspect, the present invention further provides a valved conduit, comprising:

[0013] Prosthetic valves;

[0014] The artificial blood vessel is sutured and connected to the artificial valve through sutures at the suture part.

[0015] On the other hand, the present invention also provides a method for preparing a valved conduit, wherein the suture part of an artificial blood vessel is docked with the suture edge of an artificial valve, and the artificial blood vessel is sutured at the suture part and the suture edge of the artificial valve using sutures; before the suturing operation, an elastic bridging layer is pre-coated on the outer surface of the suture part of the artificial blood vessel, or an elastic bridging layer is sleeved on the outer surface of the suture part of the artificial blood vessel during the suturing operation.

[0016] In another aspect, the present invention further provides a valved conduit, comprising:

[0017] Prosthetic valves;

[0018] An artificial blood vessel is sutured and connected to an artificial valve via sutures at a suture portion. An elastic bridging layer is provided on the suture portion of the artificial blood vessel. The bridging layer is provided to cover the outer surface of the suture portion of the artificial blood vessel after the artificial blood vessel is sutured and connected to the artificial valve, so that the bridging layer can seal pinholes formed on the artificial blood vessel during the suture operation.

[0019] In some embodiments, the bridging layer is obtained by coating a high molecular polymer material on the outer surface of the suture portion of the artificial blood vessel after suturing.

[0020] In some embodiments, the thickness of the bridging layer at the corresponding suture position is not less than 0.2 mm.

[0021] On the other hand, the present invention also provides a method for preparing a valved conduit, wherein the suture part of the artificial blood vessel is docked with the suture edge of the artificial valve, and the artificial blood vessel is sutured at the suture part and the suture edge of the artificial valve using sutures; after suturing, a high molecular polymer material is coated on the outer surface of the suture part of the artificial blood vessel to form an elastic bridging layer.

[0022] Compared with the prior art, the present invention has the following advantages and beneficial effects:

[0023] By setting a bridging layer with a certain elasticity at the suture part of the artificial blood vessel, utilizing the elasticity of the bridging layer, the force exerted by the suture on the bridging layer, and the sealing performance of the bridging layer material, the bridging layer can seal the pinholes formed on the artificial blood vessel during the suturing operation, thereby effectively solving the problem of leakage at the suture position when suturing artificial blood vessels made of fabric materials.

[0024] In the valved conduit of the present invention, the artificial blood vessel is directly sutured and connected between the suture part and the suture edge of the artificial valve. Under the action of the suture, the bridging layer provided on the artificial blood vessel and the suture edge made of silicone material can form a tight bond due to their elasticity, which effectively solves the problem of large blood leakage at the suture position of the valved conduit.

[0025] In the valved conduit of the present invention, a layer of polymer material is coated on the outside of the suture position between the artificial blood vessel and the artificial valve after suturing to form a bridging layer that can cover the pinholes on the artificial blood vessel. The sealing performance of the bridging layer effectively solves the problem of leakage of the valved conduit at the suture position.

[0026] The present invention makes only minor improvements to artificial blood vessels and valved conduits, does not damage the original form of the artificial blood vessels, has low cost, is easy to use and operate, and can achieve a good anti-leakage effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] 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 illustrate certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other relevant drawings can be obtained based on these drawings without paying any creative work.

[0028] FIG1 is a schematic structural diagram of an embodiment of an artificial blood vessel of the present invention.

[0029] FIG2 is a cross-sectional view of the structure of the artificial blood vessel in FIG1 .

[0030] FIG3 is a schematic structural diagram of an embodiment of an artificial blood vessel without a sinus according to the present invention.

[0031] FIG4 is a structural cross-sectional view of the artificial blood vessel in FIG3 .

[0032] FIG5 is a schematic structural diagram of an embodiment of an artificial blood vessel with a sinus according to the present invention.

[0033] FIG6 is a cross-sectional view of the structure of the artificial blood vessel in FIG5 .

[0034] FIG7 is a schematic structural diagram of the valved conduit of the present invention in a sutured connection state.

[0035] FIG8 is a partial schematic diagram of point A in FIG7 .

[0036] FIG9 is a cross-sectional view of the structure of the valved pipe in FIG7 .

[0037] FIG10 is a partial schematic diagram of point B in FIG9 .

[0038] FIG11 is a cross-sectional view of the structure of another embodiment of the valved conduit of the present invention in a sutured connection state.

[0039] FIG12 is a partial schematic diagram of point C in FIG11 .

[0040] Among them: 10. Artificial blood vessel, 101. Suture part, 11. Bridging layer; 20. Artificial valve, 201. Suture edge; 30. Suture; 40. Valve holder, 41. Binding line. DETAILED DESCRIPTION

[0041] 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.

[0042] During the implantation of artificial blood vessels or valved conduits, it is generally desired that the leakage at the suture position be as small as possible. However, for artificial blood vessels made of fabric, when the artificial blood vessels are sutured to other components such as artificial valves, the suture needles and sutures will form needle holes of a certain size on the artificial blood vessels, resulting in large leakage at the suture position. This leakage is often not allowed during the implantation of artificial blood vessels or valved conduits.

[0043] To address this problem, in some embodiments of the present invention, an elastic bridging layer is provided at the suture portion of the artificial blood vessel made of fabric material. When the artificial blood vessel is sutured to another component at the suture portion using sutures, the elasticity of the bridging layer and the force exerted by the sutures on the bridging layer during the suture connection are utilized to enable the bridging layer to seal the pinholes formed on the artificial blood vessel and the bridging layer during the suture operation, thereby solving the problem of large leakage that is prone to occur at the suture position.

[0044] In the artificial blood vessel of the above structure, the suture portion refers to the connection portion used to suture the artificial blood vessel to other components so that the artificial blood vessel can be sutured to other components by sutures; as shown in Figures 2, 4 and 6, the suture portion is usually located at the end position of one end of the artificial blood vessel.

[0045] The suturing position refers to the position on the suture part of the artificial blood vessel where the suture needle and suture pass through and where the suture is located when the artificial blood vessel is sutured and connected.

[0046] The elasticity of the bridging layer mentioned in this article refers to the reversible deformation property of its material, which enables it to produce a larger deformation under the action of a smaller external force and return to its original shape after the external force is removed; for example, it is similar to the performance characteristics of rubber and silicone.

[0047] In some embodiments, as shown in Figures 1, 2, 3, 4, 5, and 6, the bridging layer can be formed by coating the outer surface of the artificial blood vessel suture portion with a polymer material. For example, a layer of a colloid material such as silicone can be coated on the outer surface of the artificial blood vessel suture portion to form a silicone layer with a certain elasticity. It can be seen that due to the elasticity of the silicone, the elastic deformation of the silicone layer during the suturing operation can seal the pinholes formed on the silicone layer and the pinholes on the artificial blood vessel. In addition to coating with silicone, other polymer materials that can be used as medical materials, are cured at room temperature or by ultraviolet light, and have a certain elasticity after curing can also be used to coat the outer surface of the artificial blood vessel suture portion to form a bridging layer with a certain elasticity.

[0048] In some embodiments, the bridging layer can also be formed into a loop that can be placed over the outer surface of the suture portion of the artificial blood vessel. The loop can be made of silicone or other high molecular polymers that can be used as medical materials and formed into a ring-shaped structure that can cooperate with the artificial blood vessel. During the suturing operation, the loop is placed over the outer surface of the suture portion of the artificial blood vessel and sutured together with the artificial blood vessel. At this time, the loop can also have the effect of blocking the pinhole due to its elasticity and sealing properties and the force applied by the suture.

[0049] It is easy to imagine that the bridging layer here can also be formed by coating a high molecular polymer material or setting a ring on the inner surface of the artificial blood vessel suture part, that is, the bridging layer is set on the inner surface of the artificial blood vessel suture part. After suture connection, the bridging layer is located between the fabric layer and other components of the artificial blood vessel, which can also reduce the leakage at the suture position.

[0050] In some embodiments, in order to achieve a good occlusion of the pinhole through the elasticity of the bridging layer, the bridging layer may need to have a certain thickness. When the thickness is too small, it may not have a good occlusion effect. Here, the thickness of the bridging layer corresponding to the location of the pinhole is set to be no less than 0.2mm. In other words, when the bridging layer is a structure of uniform thickness, its wall thickness can be set to be no less than 0.2mm; when the bridging layer is a structure of irregular cross-section, its thickness at the suture position should be ensured to be no less than 0.2mm. In addition, from the perspective of actual use and the overall appearance of the artificial blood vessel, the maximum thickness of the bridging layer can usually be set to no more than 1.5mm.

[0051] Taking the artificial blood vessels without sinuses and with sinuses shown in Figures 4 and 6 as examples, artificial blood vessels generally use a corrugated tube structure. For artificial blood vessels without sinuses, as shown in Figure 4, the suture portion of this artificial blood vessel is a corrugated structure, and when suturing, the suture is generally passed through the trough of the corrugated structure. At this time, the bridging layer is formed or set at the trough of the corrugated structure. This not only facilitates the formation or setting of the bridging layer on the artificial blood vessel, but also ensures that when the bridging layer is formed or set on the artificial blood vessel, the artificial blood vessel has a good overall appearance structure and can also achieve a good sealing and plugging effect. As shown in Figure 6, for artificial blood vessels with sinuses, the suture portion of this artificial blood vessel is generally a straight tube structure, and the bridging layer is generally an annular structure with the same thickness at each position that cooperates with the suture portion.

[0052] On the other hand, some embodiments of the present invention provide a valved conduit, which uses the artificial blood vessel in the above embodiment, as shown in Figures 7, 8, 9 and 10, including:

[0053] Artificial valve, where the artificial valve can be a biological valve or a mechanical valve, wherein the biological valve is a valve processed by a dry method;

[0054] Artificial blood vessels are sutured and connected to artificial valves through sutures at the suture part. An elastic bridging layer is provided on the artificial blood vessel at its suture part. When the artificial blood vessel is sutured and connected to the artificial valve, the elasticity of the bridging layer and the force exerted by the suture on the bridging layer enable the bridging layer to seal the pinholes formed on the bridging layer and the artificial blood vessel during the suture operation.

[0055] The valved conduit adopts the artificial blood vessel in the above-mentioned embodiment. When the artificial blood vessel and the artificial valve are sutured and connected, a bridging layer is coated, formed or sleeved on the suture part of the artificial blood vessel. When suturing, the elasticity of the bridging layer and the suture edge of the artificial valve made of silicone material and the force generated by the suture between the two are utilized to enable the two to be tightly combined at the suture position, thereby preventing blood leakage and reducing the amount of blood leakage at the suture position of the valved conduit after implantation.

[0056] On the other hand, some embodiments of the present invention provide a preparation method suitable for preparing the valved conduit in the above-mentioned embodiments, comprising docking the suture portion of the artificial blood vessel with the suture edge of the artificial valve, and suturing the artificial blood vessel at the suture portion and the suture edge of the artificial valve with sutures; pre-coating an elastic bridging layer on the outer surface of the suture portion of the artificial blood vessel before the suturing operation, or sleeved an elastic ring on the outer surface of the suture portion of the artificial blood vessel as a bridging layer during the suturing operation, and passing the suture through the bridging layer and the artificial blood vessel to perform a suture connection operation on the artificial blood vessel. The above-mentioned operation methods can reduce the amount of blood leakage at the suture position of the artificial blood vessel and the valved conduit.

[0057] On the other hand, in some other embodiments of the present invention, another valved conduit with another structure is provided, as shown in FIG11 and FIG12 , the valved conduit includes:

[0058] Artificial valve, where the artificial valve can be a biological valve or a mechanical valve, wherein the biological valve is a valve processed by a dry method;

[0059] Artificial blood vessels are sutured and connected to artificial valves through sutures at the suture part. An elastic bridging layer is provided on the suture part of the artificial blood vessel. The bridging layer is provided on the outer surface of the suture part of the artificial blood vessel after the artificial blood vessel is sutured and connected to the artificial valve, so that the bridging layer can seal the pinholes formed on the artificial blood vessel during the suture operation.

[0060] In some embodiments, the bridging layer is formed by coating the outer surface of the artificial blood vessel suture portion with a polymer material. Alternatively, after suturing is completed, a ring made of the polymer material is attached to the outer surface of the suture portion by bonding or other means to cover and seal the suture site.

[0061] The high molecular polymer material here is silica gel or similar high molecular polymer material that can be used as a medical material, is cured at room temperature or by ultraviolet light, and has a certain elasticity after curing.

[0062] As can be seen from FIG12 , at this time, the bridging layer coated and covered on the suture can block the pinholes formed on the artificial blood vessel, thereby reducing leakage.

[0063] At this time, the elasticity of the bridging layer can be utilized to stably adhere the bridging layer to the artificial blood vessel, thereby improving its stability and service life.

[0064] On the other hand, some embodiments of the present invention provide a preparation method suitable for preparing valved conduits in other embodiments mentioned above, comprising docking the suture part of an artificial blood vessel with the suture edge of an artificial valve, and using sutures to sew the artificial blood vessel at the suture part and the suture edge of the artificial valve; after suturing is completed, a high molecular polymer material is coated on the outer surface of the suture part of the artificial blood vessel to form an elastic bridging layer, so that the bridging layer can seal the pinholes formed on the artificial blood vessel during the suturing operation.

[0065] 7 and 9 , taking the simultaneous replacement of the ascending aorta and aortic valve as an example, after implantation of the ascending aorta prosthesis and the aortic valve prosthesis, the leakage of the valved conduit to the outside of the blood vessel or valve should be minimized.

[0066] The ascending aorta prosthesis commonly used is made of fabric, and the aortic valve prosthesis used is a standard valve prosthesis; before implantation, one end of the ascending aorta prosthesis is sutured and connected to the suture edge of the aortic valve prosthesis with sutures. The suture edge of the aortic valve prosthesis is usually made of silicone and covered with fabric. The function of the suture edge is to suture the valve prosthesis to human tissue. When suturing the ascending aorta prosthesis and the aortic valve prosthesis, since the ascending aorta prosthesis is made of fabric, the needle holes formed in the fabric by the suture needle during the suturing operation will not automatically close, resulting in leakage at the needle hole position formed in the above-mentioned fabric after the ascending aorta prosthesis and the aortic valve prosthesis are implanted together.

[0067] Therefore, to address this issue, improvements have been made to the suture portion of the ascending aorta prosthesis. As shown in Figures 8 and 10, a bridging layer made of silicone material with a certain degree of elasticity is coated on the outer surface of the suture portion of the ascending aorta prosthesis. Thus, when the aortic valve prosthesis and the ascending aorta prosthesis are sutured together, the suture needle passes through the bridging layer and connects the ascending aorta prosthesis and the aortic valve prosthesis with the suture. At this time, the elasticity of the bridging layer and the suture edge, as well as the force generated by the suture between the two, form a tight bond between the ascending aorta prosthesis and the aortic valve prosthesis at the suture location. The elasticity of the bridging layer also seals the needle hole formed when the suture needle passes through, thereby reducing blood leakage at the suture location between the ascending aorta and the aortic valve during implantation.

[0068] Taking the implantation of the valved conduit consisting of the ascending aortic prosthesis and the aortic valve prosthesis shown in Figures 7 and 9 as an example, the valved conduit after suture connection is connected to the aortic valve prosthesis and the valve holder by tying the wire, and then the valved conduit is sent to the implantation position by the valve holder to complete the replacement implantation operation of the valved conduit.

[0069] By setting up a connection method between the binding wire, the valve holder and the aortic valve prosthesis, after completing the implantation operation of the valve-bearing tube, the binding wire can be cut in a one-size-fits-all manner to separate the valve holder from the aortic valve prosthesis and remove the valve holder.

[0070] 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 in which the product of the invention is usually placed when in use. 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. Therefore, they should not be understood as limiting the present invention.

[0071] Furthermore, the use of terms such as "horizontal" and "vertical" in the description of the present invention does not necessarily imply that the component must be absolutely horizontal or suspended, but rather that it 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 rather that it can be slightly tilted.

[0072] It should also be noted that, in the description of the present invention, unless otherwise expressly specified or limited, the terms "disposed," "installed," "connected," and "connected" should be understood in a broad sense. For example, they may refer to fixed connections, detachable connections, or integral connections; mechanical connections or electrical connections; direct connections or indirect connections through an intermediate medium; and internal connections between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention in specific contexts.

[0073] 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 scope of protection of the present invention.

Claims

1. Artificial blood vessel, characterized in that, An elastic bridging layer is provided at the suture portion of the artificial blood vessel. When the artificial blood vessel is sutured and connected to another component at the suture portion using sutures, the elasticity of the bridging layer and the force generated by the sutures on the bridging layer enable the bridging layer to block the needle holes formed on the bridging layer and the artificial blood vessel during the suturing operation.

2. The artificial blood vessel according to claim 1, wherein The bridging layer is obtained by coating a polymer material on the outer surface of the suture portion of the artificial blood vessel.

3. The artificial blood vessel according to claim 1, characterized in that, The bridging layer is a collar sleeved on the outer surface of the suture portion of the artificial blood vessel, and the collar is formed of a polymer material.

4. The artificial blood vessel according to claim 2 or 3, characterized in that, The thickness of the bridging layer at the corresponding suture position is not less than 0.2 mm.

5. The artificial blood vessel according to claim 2 or 3, characterized in that, When the suture portion of the artificial blood vessel is a corrugated structure, the bridging layer is located at the trough position of the corrugated structure.

6. The artificial blood vessel according to claim 2 or 3, characterized in that, The polymer material is silicone.

7. Valved conduit, characterized in that, Comprising: An artificial valve; And the artificial blood vessel according to any one of claims 1-6, wherein the artificial blood vessel is sutured and connected to the artificial valve at the suture portion using sutures.

8. Method for preparing a valved conduit, characterized in that, The suture portion of the artificial blood vessel is docked with the suture margin of the artificial valve, and the artificial blood vessel is sutured to the suture margin of the artificial valve at the suture portion using sutures; before the suturing operation, an elastic bridging layer is pre-coated and formed on the outer surface of the suture portion of the artificial blood vessel, or an elastic bridging layer is sleeved on the outer surface of the suture portion of the artificial blood vessel during the suturing operation.

9. Valved conduit, characterized in that, Comprising: An artificial valve; An artificial blood vessel, wherein the artificial blood vessel is sutured and connected to the artificial valve at the suture portion using sutures, and an elastic bridging layer is provided at the suture portion of the artificial blood vessel. The bridging layer is coated on the outer surface of the suture portion of the artificial blood vessel after the artificial blood vessel is sutured and connected to the artificial valve, so that the bridging layer can block the needle holes formed on the artificial blood vessel during the suturing operation.

10. The valved conduit according to claim 9, wherein The bridging layer is obtained by coating a polymer material on the outer surface of the suture portion of the artificial blood vessel after suturing.

11. The valved conduit according to claim 10, wherein, The thickness of the bridging layer at the corresponding suture position is not less than 0.2 mm.

12. Method for preparing a valved conduit, characterized in that, The suture portion of the artificial blood vessel is docked with the suture margin of the artificial valve, and the artificial blood vessel is sutured to the suture margin of the artificial valve at the suture portion using sutures; after suturing, a polymer material is coated on the outer surface of the suture portion of the artificial blood vessel to form an elastic bridging layer.

Images