Artificial sinus, valved sinus valve and valved conduit

Abstract

The application discloses an artificial sinus, a valve-bearing sinus valve and a valve-bearing pipeline. The artificial sinus is formed by sewing sheet-shaped biological materials or artificial materials, and has a conical cylinder structure or a drum-shaped balloon structure with openings at two ends. The artificial sinus formed by sewing sheet-shaped materials alone into a conical cylinder structure or a drum-shaped balloon structure can well ensure the forming shape of the artificial sinus, and the forming process is simple. The artificial sinus can be used as a connecting piece between an artificial blood vessel and a valve prosthesis, so that it can adapt to the individualized implantation requirements of valve-bearing pipelines with different shapes.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to an artificial sinus, a sinus valve, and a valved conduit. Background Technology

[0002] The aortic sinus consists of three pocket-shaped bulges at the root of the aorta, each corresponding to one of the three aortic valves. Aortic valve replacement surgery typically uses an artificial blood vessel with sinuses or a valved conduit. The sinus portion of these artificial blood vessels or valved conduits is often directly formed on the artificial blood vessel, which presents challenges in ensuring the correct sinus shape and involves complex forming processes. Summary of the Invention

[0003] The purpose of this invention is to provide an artificial sinus, a sinus valve, and a valved conduit, which solves the problems of difficulty in ensuring the shape of the sinus and the complexity of the molding process when directly molding a sinus on an artificial blood vessel.

[0004] This invention is achieved through the following technical solution: An artificial sinus is a conical or bulging balloon structure with openings at both ends, made of sheet-like biological or artificial materials sewn together.

[0005] In some embodiments, the drum-shaped balloon structure is obtained by molding a pre-formed cone structure through chemical or physical shaping.

[0006] In some embodiments, a fan-shaped sheet material is rolled into a cone-shaped structure with open ends and sewn together at the connection point. Then, the inflow end of the artificial sinus is closed and shaped to obtain an artificial sinus with a drum-shaped balloon structure.

[0007] In some embodiments, the inflow end of the artificial sinus is closed and shaped by suture stitching to obtain a drum-shaped balloon structure.

[0008] In some embodiments, the drum-shaped balloon structure is obtained by shaping the inflow end of the conical structure to be closed when connecting the artificial sinus inflow end to the valve prosthesis.

[0009] In some embodiments, one end of the sheet material corresponding to the artificial sinus inflow end has a curved structure, so that the formed artificial sinus inflow end has a waveform structure with peaks and troughs that matches the valve prosthesis connection end face.

[0010] In some embodiments, the artificial sinus is made of biomaterials.

[0011] In some embodiments, the artificial sinus, which has a drum-shaped balloon structure, has a maximum outer diameter of 32-42 mm, a height of 24-34 mm, and an outflow diameter of 24-34 mm.

[0012] On the other hand, the present invention also provides a sinus valve, including the aforementioned artificial sinus, with a valve prosthesis connected to the inflow end of the artificial sinus.

[0013] On the other hand, the present invention also provides a valved conduit, including the aforementioned artificial sinus, with an artificial blood vessel and a valve prosthesis respectively connected to the two open ends of the artificial sinus.

[0014] Compared with the prior art, the present invention has the following advantages and beneficial effects: This invention uses sheet material to individually sew and mold an artificial sinus into a cone-shaped or drum-shaped balloon structure, which can well ensure the shape of the artificial sinus and the molding process is simple. This artificial sinus can be used as a connector between artificial blood vessels and valve prostheses, so that it can be adapted to the personalized implantation needs of valved conduits of different shapes. Attached Figure Description

[0015] 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.

[0016] Figure 1 This is a schematic diagram of the fan-shaped sheet material structure used in an embodiment of the present invention.

[0017] Figure 2 This is a schematic diagram of a fan-shaped sheet material structure with a curved structure at one end, as shown in an embodiment of the present invention.

[0018] Figure 3 This is a schematic diagram of an artificial sinus with a conical structure formed from a fan-shaped sheet material, according to an embodiment of the present invention.

[0019] Figure 4 This is a schematic diagram of a drum-shaped balloon-shaped artificial sinus formed in an embodiment of the present invention.

[0020] Figure 5 This is a schematic diagram of one embodiment of the present invention, which involves closing the opening end of a conical structure.

[0021] Figure 6 This is a schematic diagram of another embodiment of the present invention for performing a closing operation on the open end of the conical structure.

[0022] Figure 7 This is a schematic diagram of the sinus valve structure according to an embodiment of the present invention.

[0023] in: 1. Artificial sinus; 11. Connection location; 12. Inflow end; 13. Overlapping part; 14. Suture; 2. Valve prosthesis. Detailed Implementation

[0024] 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.

[0025] 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.

[0026] 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. When the terms "distal" and "proximal" do not specify a reference point, the practitioner is usually used as the reference. That is, the end closer to the practitioner or farther from the patient can be considered the "proximal," while the end farther from the practitioner or closer to the patient can be considered the "distal."

[0027] Due to the unique morphology of the aortic sinus, the process of fabricating artificial blood vessels with sinus sections using artificial materials is often complex. Similarly, the fabrication of artificial blood vessels with sinus sections using biological materials presents significant challenges, and the inherent properties of biological materials often make it difficult to guarantee the morphology and quality of the sinus sections formed on the artificial blood vessel.

[0028] To solve the above-mentioned technical problems, this invention provides a method for forming an artificial sinus 1 by sewing together sheet material. Since only the sinus structure needs to be formed, the forming process is simpler and the forming shape and quality of the sinus can be guaranteed.

[0029] Reference Figure 3 and Figure 4 In some embodiments of the present invention, the artificial sinus 1 is a conical structure or a drum-shaped balloon structure made of sheet-like biomaterial or artificial material sewn together and having openings at both ends.

[0030] The aortic sinus is typically a drum-shaped balloon structure. However, in practical applications, the artificial sinus is used as a connector between the valve prosthesis and the artificial blood vessel. Therefore, in the embodiments of this invention, the formed artificial sinus can be either a drum-shaped balloon structure or a cone structure. When the cone-shaped artificial sinus is connected to the valve prosthesis, the connection operation can be used to shape the cone-shaped artificial sinus into a drum-shaped balloon structure.

[0031] Specifically, in some embodiments, the drum-shaped balloon structure is obtained by directly molding a pre-formed cone structure through chemical molding or by physical molding.

[0032] In some embodiments, an artificial sinus is adopted as follows: Figure 1 or Figure 2 The fan-shaped sheet material shown is rolled into a conical structure with open ends, and then sutured together at connection point 11 to obtain an artificial sinus with a conical structure, as shown. Figure 3 As shown; The inflow end 12 of the conical artificial sinus is narrowed to obtain a bulging balloon structure with small diameters at both ends and a large diameter in the middle, giving it a shape similar to the natural aortic sinus. Figure 4 As shown. This molding method is not only simple to operate, but also ensures the shape of the molded sinus very well.

[0033] like Figure 5 As shown in the figure, the figure illustrates the... Figure 3 One implementation method for closing the inflow end of the artificial sinus in the conical tube structure is to overlap the inflow end at one or more positions in the circumferential direction, from the position near the middle of the conical tube to the end of the inflow end. The amount of overlap 13 is greater closer to the inflow end. Then, the overlap is sutured together to obtain a drum-shaped balloon structure with small opening diameters at both ends and a gradually increasing diameter towards the middle.

[0034] like Figure 6 As shown in the figure, another implementation method for closing the inlet end is illustrated. Specifically, 2-3 stitches are sewn around the inlet end, and then 1 stitch is sewn in the axial direction and the circumferentially sewn thread 14 is tightened. Then, the process is repeated around the inlet end to close the inlet end.

[0035] In some embodiments of the present invention, such as Figure 2 As shown, the end of the sheet material corresponding to the inflow end of the artificial sinus is a curved structure, so that the formed inflow end of the artificial sinus has a wave-like structure with peaks and troughs that matches the connecting end face of the valve prosthesis. This allows the artificial sinus to form a good fit with the valve prosthesis, ensuring the forming quality of the sinus valve and valved conduit.

[0036] In some embodiments of the present invention, the drum-shaped balloon structure is obtained by closing and shaping the inflow end of the conical artificial sinus when connecting it to the valve prosthesis. For example, when suturing the inflow end of the conical artificial sinus to the suture edge of the valve prosthesis, since the diameter of the suture edge is smaller than the diameter of the inflow end of the conical structure, the inflow end of the conical structure can be closed by using the suture connection between the two to form an artificial sinus with a drum-shaped balloon structure.

[0037] Artificial sinuses can be made of either biomaterials or artificial materials. Compared to artificial materials, biomaterials have better elasticity and deformability, making it easier to connect artificial sinuses to artificial blood vessels and valve prostheses.

[0038] Biomaterials can be decellularized collagen matrix materials, such as animal pericardium, like bovine pericardium.

[0039] In forming the conical structure, a fan-shaped sheet of material is rolled into a cylindrical shape, the two ends of the sheet are joined together, and then sewn together at the joint to obtain the conical structure. At this point, a continuous transition surface can be formed on the inner wall of the conical structure.

[0040] The artificial sinus in this embodiment of the invention has a drum-shaped balloon structure with a maximum outer diameter of 32-42 mm, a height of 24-34 mm, and an outflow diameter of 24-34 mm. The main dimensions of artificial sinuses of different specifications are shown in Table 1.

[0041] Table 1 24 32 24 26 34 26 28 36 28 30 38 30 32 40 32 34 42 34 This invention also provides a sinus valve in this embodiment, such as... Figure 7 As shown, the sinus valve uses the artificial sinus 1 in the above embodiment, and the valve prosthesis 2 is connected to the inflow end of the artificial sinus. The valve prosthesis 2 and the artificial sinus 1 can be connected by sutures to form a sinus valve.

[0042] This invention also provides a valved conduit, which uses the artificial sinus described in the above embodiments. An artificial blood vessel and a valve prosthesis are connected to the two open ends of the artificial sinus, respectively. The valve prosthesis, the artificial blood vessel, and the artificial sinus are connected by sutures.

[0043] 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. An artificial sinus, characterized in that, It is a conical or drum-shaped balloon structure with openings at both ends, formed by sewing together sheet-like biological or artificial materials.

2. The artificial sinus according to claim 1, characterized in that, The drum-shaped balloon structure is obtained by molding a pre-formed cone structure through chemical or physical shaping.

3. The artificial sinus according to claim 2, characterized in that, A fan-shaped sheet of material is rolled into a cone-shaped structure with open ends and sewn together at the connection point. Then, the inflow end of the artificial sinus is closed and shaped to obtain an artificial sinus with a drum-shaped balloon structure.

4. The artificial sinus according to claim 3, characterized in that, The artificial sinus inflow end was closed and shaped using sutures to obtain a drum-shaped balloon structure.

5. The artificial sinus according to claim 1, characterized in that, The drum-shaped balloon structure is obtained by shaping the inflow end of the conical structure to be closed when connecting the artificial sinus inflow end to the valve prosthesis.

6. The artificial sinus according to any one of claims 1, 2, or 5, characterized in that, The sheet material has a curved structure at one end corresponding to the artificial sinus inflow end, so that the formed artificial sinus inflow end has a waveform structure with peaks and troughs that matches the valve prosthesis connection end face.

7. The artificial sinus according to claim 1, characterized in that, The artificial sinus is made of biological materials.

8. The artificial sinus according to claim 1 or 5, characterized in that, An artificial sinus with a turbulent balloon structure has a maximum outer diameter of 32-42 mm, a sinus height of 24-34 mm, and an outflow diameter of 24-34 mm.

9. With sinus valve, characterized in that, The artificial sinus includes any one of claims 1-8, wherein a valve prosthesis is connected to the inflow end of the artificial sinus.

10. A valved pipe, characterized in that, The artificial sinus includes any one of claims 1-8, wherein an artificial blood vessel and a valve prosthesis are respectively connected to the two opening ends of the artificial sinus.

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