Vascular prosthesis, valved conduit and method of forming

Abstract

The application discloses a blood vessel prosthesis, a valved conduit and a forming method, which comprises a tube body formed by biological material; a plurality of constraint rings are arranged on the tube body in a longitudinal direction of the tube body at intervals; the constraint rings are arranged in a ring shape outside the tube body in a circumferential direction of the tube body, so that when the tube body is subjected to pressure from inside to outside in a radial direction of the tube body, the tube body can form a bellows structure with wave troughs at positions of the constraint rings and wave crests between the constraint rings. The corresponding positions of the tube body are bound by the constraint rings, so that when the tube body is expanded outwardly under the action of internal pressure, wave troughs can be formed at the positions of the constraint rings on the tube body, and wave crests can be formed between the constraint rings, so that the blood vessel prosthesis in a bellows structure can be obtained.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of biological medical technology, and particularly relates to a vascular prosthesis, a valved conduit and a forming method. BACKGROUND

[0002] The valved conduit is an artificial blood vessel with a valve, and the valved conduit generally comprises an artificial blood vessel and an artificial valve and is used for simultaneous replacement and implantation of the ascending aorta and the aortic valve. The artificial blood vessel of the valved conduit generally adopts a bellows tube structure with wave crests and wave troughs. The artificial blood vessel with such a bellows tube structure is currently generally formed by directly weaving an artificial fabric material. SUMMARY

[0003] The present application aims to provide a vascular prosthesis and a forming method to form a bellows structure on an artificial blood vessel made of biological material.

[0004] The present application also aims to provide a valved conduit using the vascular prosthesis.

[0005] The present application is achieved by the following technical solutions:

[0006] The vascular prosthesis comprises a tube body formed of biological material, and is characterized in that a plurality of constraint rings are arranged at intervals along the longitudinal direction of the tube body on the tube body, and the constraint rings are respectively arranged in a ring around the tube body outside the tube body in the circumferential direction of the tube body, so that when the inside of the tube body is subjected to pressure in the radial direction of the tube body, the tube body can form a bellows tube structure with wave troughs at the positions of the constraint rings and wave crests between the constraint rings.

[0007] In some embodiments, the constraint ring is a closed ring structure formed by a suture, and the diameter of the constraint ring is smaller than the diameter of the tube body at the position of the constraint ring.

[0008] In some embodiments, the constraint ring is a closed ring structure independent of each other.

[0009] In some embodiments, when the constraint ring is formed by a suture, the suture is threaded in the nap layer of the outer wall of the tube body, so that the constraint ring is connected to the tube body through the nap layer.

[0010] In some embodiments, the tube body is formed by rolling a sheet of biological material into a tubular structure, abutting the two free ends to form a layering arrangement with outwardly protruding stitching edges, and then stitching the stitching edges to obtain.

[0011] In some embodiments, when the constraint ring is formed by a suture, the suture is threaded through the stitching edge to connect the constraint ring to the stitching edge.

[0012] In some embodiments, the radius difference between the wave crest and the wave trough formed on the tube body is 0.5-3 mm.

[0013] In some embodiments, the spacing between the constraint rings on the tube body is set to 2-6mm.

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

[0015] In some embodiments, the biological material is a bovine pericardium material.

[0016] In another aspect, the present application also provides a blood vessel prosthesis with a sinus, wherein a sinus is arranged at one end of the tube body of the blood vessel prosthesis.

[0017] In another aspect, the present application also provides a method for forming a blood vessel prosthesis, comprising:

[0018] rolling and connecting the sheet-shaped biological material to form a tube body;

[0019] using sutures to form a plurality of constraint rings in the form of closed loop structures along the circumference of the tube body, the constraint rings being arranged at intervals along the longitudinal direction of the tube body, and the diameter of the constraint rings being smaller than the diameter of the tube body at the positions of the constraint rings, so that when the tube body is subjected to pressure from the inside in the radial direction of the tube body, the tube body can form a bellows structure with troughs at the positions of the constraint rings and peaks between the constraint rings.

[0020] In some embodiments, a sinus is formed at one end of the tube body formed or a structure for forming a sinus is formed, and the constraint rings are arranged on the part other than the sinus.

[0021] In another aspect, the present application also provides a valved conduit, comprising:

[0022] an artificial valve;

[0023] and a blood vessel prosthesis, or a blood vessel prosthesis with a sinus.

[0024] Compared with the prior art, the present application has the following advantages and beneficial effects:

[0025] In the present application, a plurality of constraint rings are arranged on the tube body formed by the biological material, and the corresponding positions of the tube body are bound by the constraint rings, so that when the tube body is subjected to internal pressure and expands outward, troughs are formed at the positions of the constraint rings on the tube body, and peaks are formed between the constraint rings, thereby obtaining a blood vessel prosthesis in the form of a bellows structure.

[0026] The present application utilizes the structural features of the biological material, uses the smooth surface of the biological material as the inner wall of the tube body, makes the inside of the tube body have a smooth surface, uses the side of the biological material with the villi as the outer wall of the tube body, forms a villus layer on the outer wall of the blood vessel prosthesis by the villi, and stably connects the constraint ring formed by the suture on the tube body by the villus layer. The connection of the constraint ring on the tube body is convenient, and the arrangement of the constraint ring formed by the suture on the tube body will not cause damage to the tube body. BRIEF DESCRIPTION OF DRAWINGS

[0027] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some of the embodiments of the present application, and therefore should not be considered as a limitation on the scope. For those skilled in the art, other related drawings can also be obtained without creative labor.

[0028] Figure 1 For one embodiment of the blood vessel prosthesis in the present application, a structural schematic diagram is shown.

[0029] Figure 2 For the blood vessel prosthesis in the present application, a partial schematic diagram is shown.

[0030] Figure 3 For the blood vessel prosthesis with a sinus in the present application, a structural schematic diagram is shown.

[0031] Figure 4 For the tube body for forming the blood vessel prosthesis with a sinus in the present application, a structural schematic diagram is shown.

[0032] Wherein:

[0033] 10, tube body, 101, wave crest, 102, wave trough, 11, suture edge, 12, constraint ring;

[0034] 20, sinus portion, 21, sinus portion forming structure. DETAILED DESCRIPTION

[0035] In order to make the purpose, technical solutions and advantages of the embodiments of the present application more clear, the technical solutions in the embodiments of the present application will be described clearly and completely below in combination with the drawings in the embodiments of the present application. Obviously, the described embodiments are some of the embodiments of the present application, but not all of the embodiments.

[0036] In the transplantation of aortic conduit, the artificial blood vessel of the ascending aorta conduit is usually arranged in a bellows structure. The design of the bellows structure can avoid the artificial blood vessel from being wrinkled at the bending position, thereby reducing the risk of thrombosis at the wrinkled position of the artificial blood vessel. At the same time, the design of the bellows structure is beneficial to the blood flow, can reduce the impact of blood flow on the artificial blood vessel, reduce the pressure difference of the valve, improve the blood flow efficiency, and plays an important role in improving the service life of the valved conduit and better meeting the needs of different patients.

[0037] At present, in the artificial blood vessels formed by weaving fabric materials, the artificial blood vessels in the bellows structure are usually formed by weaving or heat treatment. However, these forming methods of the bellows structure are obviously not suitable for artificial blood vessels prepared from biological materials.

[0038] Therefore, one purpose of the present application is to form a bellows structure on an artificial blood vessel prepared from biological materials, or to prepare an artificial blood vessel in a bellows structure from biological materials.

[0039] In some embodiments of the present application, referring to Figure 1 and Figure 2 , the vascular prosthesis comprises a tube body 10 formed from biological materials;

[0040] A plurality of constraint rings 12 are arranged on the tube body 10 at intervals along the longitudinal direction of the tube body, and the constraint rings 12 are arranged in a ring shape around the tube body in the circumferential direction of the tube body. When the tube body is in an inflated state due to the pressure acting on the inside of the tube body in the radial direction of the tube body, the tube body can form a bellows structure having wave troughs 102 at the positions of the constraint rings and wave crests 101 between the constraint rings.

[0041] The method for forming the tube body from biological materials can be to roll the sheet-shaped biological material into a tubular shape and to suture the joint formed by rolling. In addition to the suture method, other connection methods such as adhesion can also be used.

[0042] The biological material used to form the vascular prosthesis can be a decellularized collagen matrix material, such as a sheet of pericardium of a human or an animal, or a similar sheet of tissue, such as bovine pericardium.

[0043] A plurality of constraint rings are arranged at intervals on the formed tube body, and the constraint rings constrain the deformation of the tube body in the radial direction when the tube body is subjected to internal pressure. When the tube body is subjected to pressure acting in the radial direction of the tube body, wave troughs can be formed at the positions of the constraint rings, and wave crests can be formed between the constraint rings, so that the tube body assumes a bellows shape, thereby obtaining a vascular prosthesis in a bellows structure.

[0044] Based on the role played by the constraint ring in the blood vessel prosthesis, the constraint ring is generally a closed ring structure with a certain flexibility to facilitate the implantation operation of the blood vessel prosthesis, and a certain rigidity to enable it to provide a stable constraint to the flexible tube of the biological material when subjected to external force.

[0045] In some embodiments, the constraint ring 12 is a closed ring structure formed by a suture, and the diameter of the constraint ring is smaller than the diameter of the tube at the position where the constraint ring is located. Since the deformation of the suture under the pressure inside the tube is very small, when the diameter of the constraint ring is set to be smaller than the diameter of the tube at the position where the constraint ring is located, the closed ring structure formed by the suture can effectively constrain the deformation of the tube in the radial direction. Moreover, the flexible characteristics of the suture enable it to deform to any form with the tube when not subjected to the tube, so as to facilitate the implantation operation of the blood vessel prosthesis.

[0046] The constraint ring is formed by a suture, which is convenient to connect on the tube of the biological material and has a certain structural strength, so as to facilitate the formation of the blood vessel prosthesis, facilitate the implantation of the blood vessel prosthesis, and reduce the processing cost of the blood vessel prosthesis.

[0047] In some embodiments, the constraint ring is a closed ring structure independent of each other. For example, the constraint ring is a closed ring structure formed by winding a piece of suture on the tube in the circumferential direction of the tube and knotting the two ends, at this time, there is no connection relationship between each constraint ring. Or, the constraint ring on the tube is formed by winding a suture on the tube at one position and knotting to form a closed ring structure, then winding the suture on the tube at another position and knotting to form another closed ring structure, and sequentially forming multiple constraint rings on the tube, at this time, although there is a connection relationship between each constraint ring, since each constraint ring is a closed ring structure formed by knotting each circle of suture independently, each constraint ring is still independent of each other.

[0048] The advantage of this structure is that when any of the constraint rings fails, such as breaking or knot slipping, it will not affect the function of the other constraint rings.

[0049] The constraint ring can provide a binding force to the tube, but it needs to be stably connected to the tube, so as to ensure the stability of the bellows structure. Taking the constraint ring formed by a suture as an example, in order to stably connect the suture to the tube, it is usually necessary to use a sewing method to pass the suture through the tube and connect it to the tube; but this connection method will form a needle hole on the tube, which is easy to damage the tube and cause leakage.

[0050] In some embodiments of the present application, the structural features of the biological material are utilized to solve the problem of connecting the constraint ring to the tube.

[0051] For example, a tube formed by using bovine pericardium material, the bovine pericardium material has one smooth surface and one surface with villi. In the forming process, the smooth surface of the bovine pericardium forms the inner wall of the tube, and the outer wall of the tube is attached to the villi layer formed by the villi. The villi layer is similar to the adhesive surface of a magic tape, and has pores that can be penetrated by the suture. Therefore, when the suture is arranged in the villi layer, the constraint ring formed by the suture can be stably connected to the outer wall of the tube by utilizing the structural features of the villi layer.

[0052] The constraint ring is connected to the tube through the villi layer on the outer wall of the tube, which not only facilitates the connection of the constraint ring to the outer wall of the tube, but also does not cause any damage to the tube.

[0053] In some embodiments, the tube can be formed by rolling the sheet-shaped biological material into a tubular shape, aligning and stacking the two end portions to form outwardly protruding sewing edges, and then sewing the sewing edges with sutures.

[0054] The tube can also be formed by using a chemical fixation method, for example, the biological material that has not been chemically fixed is sewn into a tube, and then a chemical fixation method is used for shaping treatment to form the corrugated structure.

[0055] Generally, the radius difference between the wave crest and the wave trough formed on the tube is set to 0.5-3 mm. The spacing between the constraint rings on the tube is set to 2-6 mm, i.e., the wave amplitude length of each corrugated structure on the tube is 2-6 mm.

[0056] Some embodiments of the present application also provide a blood vessel prosthesis with a sinus, which is provided with a sinus portion of a blood vessel at one end of the tube of the blood vessel prosthesis, as shown in Figure 3

[0057] On the other hand, the present application also provides a forming method of a blood vessel prosthesis. In some embodiments, the forming method of the blood vessel prosthesis comprises:

[0058] rolling the sheet-shaped biological material and connecting the joint formed by the rolling to form a tube;

[0059] ​The sewing thread is arranged along the circumference of the tube body outside the tube body to form a plurality of closed ring structures, the closed ring structures are arranged at intervals along the longitudinal direction of the tube body, and the diameter of the closed ring structure is smaller than the diameter of the tube body at the position of the closed ring structure, so that when the tube body is subjected to pressure outwardly along the radial direction of the tube body, the tube body can form a bellows structure having wave troughs at the positions of the closed ring structures and wave crests between the closed ring structures.

[0060] The preparation of the tube body can adopt the method of rolling the sheet-shaped biological material into a tubular shape, aligning the two free ends of the sheet-shaped material and making the inner walls adhere, forming a laminated structure at the position, obtaining a tube body with outwardly protruding stitching edges, and then stitching the stitching edges to obtain a tube body with a water droplet-shaped cross section.

[0061] The stitching method of the stitching connection of the stitching edges can adopt the stitch line pressing stitching method of the lap joint method, or the double-thread stitching method of the hemming method.

[0062] When the sewing thread is formed into a closed ring structure, the sewing thread can be passed through the stitching edge formed during the forming of the tube body, so that each closed ring structure is directly connected between the position and the tube body.

[0063] For example, the sewing thread can be passed through the pile layer, and after the sewing thread is wrapped around the tube body once, the sewing thread is passed through the stitching edge, and then the sewing thread is knotted at the position of the stitching edge to complete the forming of one closed ring structure; then the sewing thread is moved to the forming position of the next closed ring, and the sewing thread is passed through the stitching edge and then the pile layer, and the previous operation is repeated to form another closed ring; the cycle is repeated in sequence, so that a plurality of closed ring structures required on the tube body can be formed by one sewing thread; and at this time, each closed ring structure is independent of each other.

[0064] When the sewing thread is formed into a closed ring structure on the tube body, the tube body formed by stitching can be sleeved on a forming mold, the outer surface of the forming mold is in a bellows structure, and then the sewing thread is used to form each closed ring at each wave trough position of the forming mold, so that the vascular prosthesis is obtained.

[0065] The prepared vascular prosthesis can be treated by a dry process, and after sterilization by a gas (EO), the vascular prosthesis is stored in a non-liquid environment.

[0066] On the other hand, the present application also provides a forming method of a vascular prosthesis with a sinus, for example, a sinus is directly formed at one end of the tube body during the forming of the tube body, or a structure for forming a sinus is formed at a section of the tube body, the structure for forming a sinus can be a flared structure formed at the end of the tube body, as shown in Figure 4 .

[0067] The preparation of the tube body with the sinus at one end can be cutting the sheet material according to the unfolded shape of the tube body and the sinus, so that the tube body with the sinus 20 at one end can be directly formed when the cutting pieces are connected by sewing. At this time, the constraint ring is arranged at the position of the tube body except the sinus, so that the vascular prosthesis with the sinus can be prepared. Referring to Figure 4 For the tube body with the sinus forming structure 21 for forming the sinus, the opening of the trumpet can be connected by closing when the vascular prosthesis is connected with the artificial valve, and the sinus can also be formed at the end of the vascular prosthesis.

[0068] On the other hand, the application also provides a valved conduit, which comprises an artificial valve and the vascular prosthesis or the vascular prosthesis with the sinus in the above embodiments, and the sewing of the valve seat of the artificial valve and the sewing part of the vascular prosthesis is connected by sewing thread, so as to obtain the valved conduit.

[0069] In the description of the application, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship when the product of the application is usually placed, and are only for the convenience of describing the application and simplifying the description, and therefore cannot be understood as indicating or implying that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the application.

[0070] In addition, the terms "horizontal", "vertical" and the like in the description of the application do not mean that the components must be absolutely horizontal or vertical, but can be slightly inclined. For example, "horizontal" only means that it is more horizontal relative to "vertical", and does not mean that the structure must be completely horizontal, but can be slightly inclined.

[0071] In the description of the application, it should also be noted that unless otherwise specified and limited, if the terms "arrangement", "installation", "connection", "connection" appear, they should be understood in a broad sense, for example, they can be fixedly connected, or can be detachably connected, or integrally connected; can be mechanically connected, or can be electrically connected; can be directly connected, or indirectly connected through an intermediate medium; can be connected inside two elements. For those skilled in the art, the specific meaning of the above terms in the application can be understood in conjunction with the specific circumstances.

[0072] The above is only the preferred embodiment of the application, and does not limit the application in any form. Any simple modification or equivalent change made according to the technical essence of the application to the above embodiments falls within the protection scope of the application.

Claims

1. A vascular prosthesis, comprising a tube formed from biomaterials; characterized in that, Multiple constraint rings are spaced apart along the longitudinal direction of the tube body. The constraint rings are arranged around the outside of the tube body along the circumference of the tube body, so that when the inside of the tube body is subjected to pressure from the radial direction of the tube body, the tube body can form a corrugated tube structure with troughs at the location of the constraint rings and crests between the constraint rings. The smooth side of the biomaterial is used as the inner wall of the tube, giving the tube a smooth surface inside. The villous side of the biomaterial is used as the outer wall of the tube. A villous layer formed by the villous layer is formed on the outer wall of the vascular prosthesis. The villous layer is used to stably connect the constraint ring formed by the suture to the tube.

2. The vascular prosthesis according to claim 1, characterized in that, The constraint ring is a closed ring structure formed by stitching, and the diameter of the constraint ring is smaller than the diameter of the tube at its location.

3. The vascular prosthesis according to claim 2, characterized in that, The constraint rings are mutually independent closed ring structures.

4. The vascular prosthesis according to claim 2 or 3, characterized in that, When using a sewn-formed constraint ring, the sewn thread is inserted into the pile layer on the outer wall of the tube, so that the constraint ring is connected to the tube through the pile layer.

5. The vascular prosthesis according to claim 1, 2, or 3, characterized in that, The tube is formed by rolling sheet-like biomaterial into a tubular structure and stacking the two free ends together to form a suture edge with outward protrusions, and then suturing the suture edge together.

6. The vascular prosthesis according to claim 5, characterized in that, When using a suture-formed constraint ring, the suture is passed through the seam edge so that the constraint ring is connected to the seam edge.

7. The vascular prosthesis according to claim 1, characterized in that, The biomaterial is a decellularized collagen matrix material.

8. A vascular prosthesis with sinuses, characterized in that, The vascular prosthesis according to any one of claims 1-7 has a sinus portion at one end of its tube body.

9. A method for forming a vascular prosthesis, characterized in that, include: Sheet-shaped biomaterials are rolled up and connected to form tubes; Multiple closed-loop constraint rings are formed by suturing around the outside of the tube body and surrounding it. The constraint rings are spaced apart along the longitudinal direction of the tube body, and the diameter of the constraint ring is smaller than the diameter of the tube body at its location. This allows the tube body to form a corrugated tube structure with troughs at the location of the constraint rings and crests between the constraint rings when the tube body is subjected to pressure in the radial direction of the tube body. The smooth side of the biomaterial is used as the inner wall of the tube, giving the tube a smooth surface inside. The villous side of the biomaterial is used as the outer wall of the tube. A villous layer formed by the villous layer is formed on the outer wall of the vascular prosthesis. The villous layer is used to stably connect the constraint ring formed by the suture to the tube.

10. The method for forming a vascular prosthesis according to claim 9, characterized in that, A sinus or a structure for forming the sinus is formed at one end of the formed tube, and a constraint ring is provided in the part other than the sinus.

11. A valved pipe, characterized in that, include: Artificial valves; And the vascular prosthesis according to any one of claims 1-7, or the vascular prosthesis with sinus according to claim 8.

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