Vascular prosthesis

Abstract

The invention discloses a vascular prosthesis which is of a tubular structure formed by curling a sheet-shaped natural biological material and connecting the sheet-shaped natural biological material with a joint part, and the leakage rate of the vascular prosthesis under the pressure of 120 mmHg is not larger than 5 mL / (min.cm < 2 >). The blood vessel prosthesis is formed by sewing natural biological materials in a curled mode, the problem of biocompatibility can be well solved, meanwhile, the blood vessel prosthesis obtained by sewing bovine pericardium materials in a curled mode has the good effect on leakage prevention, and the blood vessel prosthesis has the good practical application value in clinical application.

Description

Technical Field

[0001] The present invention relates to the field of biomedical technology, and in particular to a vascular prosthesis. Background Art

[0002] At present, artificial blood vessels are widely used in clinical practice and have achieved good results in some aspects. Blood vessels commonly used for transplantation in clinical practice are mainly divided into two categories: one is biological blood vessels represented by autologous blood vessels, and the other is artificial branched blood vessels, such as polymer synthetic material blood vessels represented by polyester and expanded polytetrafluoroethylene. This kind of artificial blood vessels made of polymer synthetic materials often have poor biocompatibility, which limits their application in clinical practice. Summary of the invention

[0003] The purpose of the present invention is to provide a vascular prosthesis to solve the problems of poor biocompatibility and clinical application of existing artificial blood vessels.

[0004] The present invention is achieved through the following technical solutions: The vascular prosthesis is a tubular structure made of sheet-like natural biological materials, which are curled and connected at the joints. The leakage rate of the vascular prosthesis under a pressure of 120 mmHg is not more than 5 mL / (min·cm 2 ).

[0005] In some embodiments, the leakage rate of the vascular prosthesis at a pressure of 120 mmHg is no greater than 0.5 mL / (min·cm 2 ).

[0006] In some embodiments, the leakage rate of the vascular prosthesis at a pressure of 120 mmHg is no greater than 0.1 mL / (min·cm 2 ).

[0007] In some embodiments, the natural biological material is a decellularized collagen matrix material, preferably a bovine pericardium material.

[0008] In some embodiments, the joints are connected by sewing.

[0009] In some embodiments, the joints are connected by bonding.

[0010] In some embodiments, the vascular prosthesis is chemically sterilized and stored in a preservation solution, and can be implanted after being cleaned with a cleaning solution before surgery.

[0011] In some embodiments, the vascular prosthesis is dry-processed with a dry liquid, sterilized with a gas, and stored in a non-liquid environment, and can be implanted directly during surgery or after being soaked in saline before surgery.

[0012] In some embodiments, an elastic layer is coated on the outside of the tubular structure formed by natural biological materials, and preferably, the elastic layer is made of polymer material.

[0013] In some embodiments, a functional layer is disposed inside the tubular structure formed of natural biological materials. Preferably, the functional layer is an anti-coagulation layer, an anti-intimal hyperplasia layer, or an anti-thrombotic layer.

[0014] Compared with the prior art, the present invention has the following advantages and beneficial effects: The vascular prosthesis of the present invention is made of natural biological materials by curling and sewing, which can well solve the problem of biocompatibility. At the same time, the vascular prosthesis made of bovine pericardium materials by curling and sewing has a good effect in preventing leakage and has good practical application value in clinical application. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] 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.

[0016] Figure 1 This is a schematic structural diagram of one embodiment of the vascular prosthesis of the present invention.

[0017] Figure 2 It is a schematic cross-sectional view of an embodiment of a vascular prosthesis of the present invention.

[0018] in: 10. vascular prosthesis, 11. natural biomaterial layer, 12. functional layer, 13. elastic layer; 20. Sutures. DETAILED DESCRIPTION

[0019] 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.

[0020] In view of the problems existing in artificial blood vessels, the vascular prosthesis 10 of the present invention is a tubular structure formed by curling a sheet of natural biological material and connecting the curled joints. The curled joints can be connected by suturing with sutures 20. The structure of the corresponding vascular prosthesis can be referred to. Figure 1 As shown; bonding or other connection methods can also be used to connect the joints.

[0021] The vascular prosthesis 10 is characterized in that its leakage rate under a pressure of 120 mmHg is no greater than 5 mL / (min·cm 2 ), so that it can well meet the needs of actual clinical applications. The leakage rate here refers to the volume of water flowing out through the gap of the watertight vascular prosthesis under the specified time and pressure.

[0022] Furthermore, in one embodiment, the leakage rate of the vascular prosthesis at a pressure of 120 mmHg is no greater than 0.5 mL / (min·cm 2 ), so that it can have better effect in clinical application.

[0023] Furthermore, in one embodiment, the leakage rate of the vascular prosthesis at a pressure of 120 mmHg is no greater than 0.1 mL / (min·cm 2 ), so that it can have better effect in clinical application.

[0024] The natural biological material used in the vascular prosthesis can be acellular collagen matrix material, such as bovine pericardium material and other existing biological materials.

[0025] In one embodiment, the prepared vascular prosthesis is chemically sterilized and then stored in a storage solution, and can be implanted after being cleaned with a cleaning solution before surgery.

[0026] In one embodiment, the prepared vascular prosthesis is dry-processed with a dry liquid, sterilized with gas (EO), and stored in a non-liquid environment, and can be implanted directly during surgery or after being soaked in saline before surgery.

[0027] In one embodiment, an elastic layer 13 is coated on the outer side of the tubular structure formed by the natural biological material, that is, the natural biological material layer 11. Figure 2 As shown, the elastic layer 13 is used to provide support for the tubular structure located inside the elastic layer 13 or to increase the elasticity of the prepared vascular prosthesis.

[0028] Specifically, the elastic layer 13 can be made of polymer materials, such as polytetrafluoroethylene, dacron, polyester, polyurethane, polyethylene, polypropylene and other medical materials.

[0029] In one embodiment, a functional layer 12 is provided inside the natural biomaterial layer 11, wherein the functional layer 12 may be an anti-coagulation layer, an anti-intimal hyperplasia layer, an anti-thrombotic layer, etc. The functional layer 12 may be a coating containing anti-coagulation or anti-intimal hyperplasia substances such as heparin, rapamycin, and paclitaxel formed on the inside of the natural biomaterial layer 11 by physical adsorption or chemical bonding.

[0030] The vascular prosthesis provided with the functional layer is particularly suitable for application in small-caliber artificial blood vessels with an inner diameter of less than 4 mm.

[0031] 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.

[0032] 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.

[0033] 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 according to specific circumstances.

[0034] 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 vascular prosthesis, characterized in that: The vascular prosthesis is a tubular structure made of sheet-like natural biological materials, which are curled and connected at the joints. The leakage rate of the vascular prosthesis under a pressure of 120 mmHg is no more than 5 mL / (min·cm 2 ).

2. The vascular prosthesis according to claim 1, characterized in that: The leakage rate of the vascular prosthesis under a pressure of 120 mmHg is no more than 0.5 mL / (min·cm 2 ).

3. The vascular prosthesis according to claim 1, characterized in that: The leakage rate of the vascular prosthesis under a pressure of 120 mmHg is no more than 0.1 mL / (min·cm 2 ).

4. The vascular prosthesis according to claim 1, 2 or 3, characterized in that: The natural biological material is a decellularized collagen matrix material, preferably a bovine pericardium material.

5. The vascular prosthesis according to claim 1, 2 or 3, characterized in that: The joints are connected by sewing.

6. The vascular prosthesis according to claim 1, 2 or 3, characterized in that: The joints are connected by bonding.

7. The vascular prosthesis according to claim 1, 2 or 3, characterized in that: After chemical sterilization, the vascular prosthesis is stored in a preservation solution and can be implanted after being cleaned with a cleaning solution before surgery.

8. The vascular prosthesis according to claim 1, 2 or 3, characterized in that: The vascular prosthesis is processed by dry process with dry liquid, sterilized by gas, and stored in a non-liquid environment. It can be implanted directly during surgery or after being soaked in saline before surgery.

9. The vascular prosthesis according to claim 1, characterized in that: An elastic layer is coated on the outside of the tubular structure formed by natural biological materials, and preferably the elastic layer is made of polymer material.

10. The vascular prosthesis according to claim 1 or 9, characterized in that: A functional layer is arranged inside the tubular structure formed of natural biological materials. Preferably, the functional layer is an anti-coagulation layer, an anti-intimal hyperplasia layer, or an anti-thrombotic layer.

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