Functional composite stent

Abstract

The embodiment of the utility model provides a functional composite support which comprises a support body, the support body comprises a plurality of layers of frame bodies arranged in a stacked mode, each layer of frame body comprises a plurality of parallel and spaced column bodies, and the column bodies are arranged in any two adjacent layers of frame bodies. The columns in one layer of the frame body and the columns in the other layer of the frame body are arranged in a crossed mode at a preset angle, and holes communicating with one another are formed among the multiple columns. The functionalized film layer is connected with the column body and is filled in the pores; and the active nano particles are embedded in the functional film layer. According to the functional composite stent provided by the embodiment of the invention, the problems of unstable physical and chemical properties, low solubility, poor bioavailability and the like of antioxidant drugs can be solved, and by embedding the active nanoparticles in the functional film layer and constructing the composite stent, the slow release performance of the active drugs is improved; therefore, bone angiogenesis is promoted, and the treatment effect of repairing bone defect regeneration is improved.

Description

Technical Field

[0001] This application belongs to the technical field of 3D printing, and particularly relates to a functional composite scaffold. Background Technology

[0002] Diabetic bone defects refer to bone damage or loss in diabetic patients due to various causes. This type of problem is relatively common in diabetic patients and is difficult to treat. Pathological characteristics mainly include: delayed healing, impaired angiogenesis, increased risk of infection, poor wound healing, osteoporosis, impaired cell function, and impaired mesenchymal stem cell function. Common causes include trauma, surgery, infection, and metabolic abnormalities.

[0003] 3D printing technology can support the manufacturing requirements of artificial bone conformation (individualized shape matching) and biomimicry (microporous structure within bone), providing an effective means to realize the fabrication of composite biomimetic bone regeneration scaffolds. Therefore, using 3D printing technology to prepare organic-inorganic composite materials with controllable external morphology and internal structure, achieving biomimicry in material composition and structural morphology to improve osteogenic performance, is an important research direction in artificial bone preparation. In the pathological context of diabetic bone defects, the design and application of functional scaffolds can significantly improve treatment outcomes and promote bone defect healing.

[0004] However, current stents and the active substances they carry are unstable and have low bioavailability, resulting in poor treatment outcomes. Utility Model Content

[0005] In view of this, embodiments of this application provide a functional composite stent to solve the technical problem that existing stents and the active substances they carry are unstable and have low bioavailability, resulting in poor treatment effects.

[0006] This application provides a functional composite stent, comprising:

[0007] The support body includes multiple layers of frames stacked together. Each layer of the frame includes multiple parallel and spaced columns. In any two adjacent layers of the frame, the columns in one layer of the frame and the columns in the other layer of the frame are arranged to intersect at a preset angle, and the multiple columns form interconnected gaps.

[0008] A functionalized film layer, connected to the column and filling the pores; and

[0009] Active nanoparticles are embedded in the functionalized film layer.

[0010] In some embodiments, in the frame structure with any two layers spaced apart, the columns in one layer of the frame structure are arranged parallel to each other or intersecting at a preset angle with the columns in the other layer of the frame structure.

[0011] In some embodiments, the preset angle is 30° to 90°.

[0012] In some embodiments, the length of the column in each layer of the frame gradually decreases from the middle of the frame towards both sides.

[0013] In some embodiments, each of the columns is of equal length.

[0014] In some embodiments, in any two adjacent frames, the column in one frame and the column in the other frame are in surface contact.

[0015] In some embodiments, the column is a prism, and in any two adjacent layers of the frame, the column in one layer of the frame and the column in the other layer of the frame are in line contact.

[0016] In some embodiments, the pore size is 100 μm to 300 μm. In a preferred embodiment, the pore size is 200 μm.

[0017] In some embodiments, the porosity of the stent body is 40% to 60%. In a preferred embodiment, the porosity of the stent body is 60%.

[0018] In some embodiments, the support body is integrally shaped as a cylinder, prism, elliptical cylinder, sphere, or ellipsoid.

[0019] When the support body is cylindrical, the diameter of the support body is 10mm±1mm and the height is 2mm±0.2mm.

[0020] In some embodiments, the support body is a 3D printed one-piece structure.

[0021] The functional composite scaffold provided in this application can solve the problems of unstable physicochemical properties, low solubility, and poor bioavailability of antioxidant drugs. By constructing a composite scaffold with active nanoparticles embedded in a functionalized membrane layer, the functional composite scaffold provided in this application can improve the sustained-release performance of active drugs in the pathological environment of diabetic bone defects, thereby promoting bone angiogenesis and improving the therapeutic effect of repairing bone defects and regenerating bone. Attached Figure Description

[0022] To more clearly illustrate the technical solutions in the embodiments of this application, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0023] Figure 1 This is a schematic diagram of the structure of the stent body in the functional composite stent provided in the first embodiment of this application. Figure 1 ;

[0024] Figure 2 This is a schematic diagram of the structure of the stent body in the functional composite stent provided in the first embodiment of this application. Figure 2 ;

[0025] Figure 3 This is a schematic diagram of the structure of the scaffold body in the functional composite scaffold provided in the second embodiment of this application;

[0026] Figure 4 This is a schematic diagram of the structure of the scaffold body in the functional composite scaffold provided in the third embodiment of this application;

[0027] Figure 5 This is a schematic diagram of the structure of the scaffold body in the functional composite scaffold provided in the fourth embodiment of this application;

[0028] Figure 6 This is a schematic diagram of the structure of the scaffold body in the functional composite scaffold provided in the fifth embodiment of this application;

[0029] Figure 7 This is a scanning electron microscope image of the scaffold body in the functional composite scaffold provided in the embodiments of this application;

[0030] Figure 8 These are scanning electron microscope images of the functionalized membrane and active nanoparticles in the functional composite scaffold provided in the embodiments of this application;

[0031] Figure 9 This is a scanning electron microscope image of the active nanoparticles in the functional composite scaffold provided in the embodiments of this application.

[0032] The attached icon numbers are as follows:

[0033] 10. Support body; 11. Frame; 12. Column; 100. Hole. Detailed Implementation

[0034] In the following description, specific details such as particular system architectures and techniques are set forth for illustrative purposes and not for limitation, in order to provide a thorough understanding of the embodiments of this application. However, those skilled in the art will understand that the embodiments of this application can also be implemented in other embodiments without these specific details. In other instances, detailed descriptions of well-known systems, apparatuses, circuits, and methods are omitted so as not to obscure the description of the embodiments of this application with unnecessary detail.

[0035] It should also be understood that the term "and / or" as used in the specification of embodiments of this application and the appended claims refers to any combination of one or more of the associated listed items and all possible combinations, and includes such combinations.

[0036] It should be noted that when a component is referred to as being "fixed to" or "set on" another component, it can be directly on or indirectly on that other component. When a component is referred to as being "connected to" another component, it can be directly connected to or indirectly connected to that other component.

[0037] It should be understood that the terms "length", "width", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", and "outer" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing the embodiments of this application and simplifying the description, and do not 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 the embodiments of this application.

[0038] Furthermore, in the description of the embodiments and the appended claims of this application, the terms "first," "second," "third," etc., are used only for distinguishing descriptions and should not be construed as indicating or implying relative importance.

[0039] In the description of embodiments in this application, references to "some embodiments" or "some embodiments" mean that one or more embodiments of this application include a specific feature, structure, or characteristic described in connection with that embodiment. Therefore, the phrases "in some embodiments," "in some embodiments," "in other embodiments," "in still other embodiments," etc., appearing in different parts of this specification do not necessarily refer to the same embodiments, but rather mean "one or more, but not all, embodiments," unless otherwise specifically emphasized. The terms "comprising," "including," "having," and variations thereof mean "including but not limited to," unless otherwise specifically emphasized. "A plurality" refers to two or more.

[0040] PLGA is the abbreviation for polylactic acid-glycolic acid copolymer.

[0041] PCL is the abbreviation for polycaprolactone.

[0042] β-TCP is the abbreviation for β-tricalcium phosphate.

[0043] This application provides a functional composite stent, such as... Figures 1 to 6 As shown, the functional composite scaffold includes a scaffold body 10, a functionalized membrane layer (not shown in the figure), and active nanoparticles (not shown in the figure).

[0044] The support body 10 includes multiple layers of frame 11 stacked together. Each layer of frame 11 includes multiple parallel and spaced columns 12. In any two adjacent layers of frame 11, the columns 12 in one layer of frame 11 and the columns 12 in another layer of frame 11 are arranged to cross each other at a preset angle, and the multiple columns 12 form interconnected holes 100.

[0045] The functionalized membrane layer is connected to the column 12 and fills the pores 100;

[0046] Active nanoparticles are embedded in the functionalized film layer.

[0047] The functional composite scaffold provided in this application can solve the problems of unstable physicochemical properties, low solubility, and poor bioavailability of antioxidant drugs. By constructing a composite scaffold with active nanoparticles embedded in a functionalized membrane layer, the functional composite scaffold provided in this application can improve the sustained-release performance of active drugs in the pathological environment of diabetic bone defects, thereby promoting bone angiogenesis and improving the therapeutic effect of repairing bone defects and regenerating bone.

[0048] In applications, such as Figure 7 As shown, 3D printing technology can support the manufacturing requirements of artificial bone conformation (individualized shape matching) and biomimicry (microporous structure within bone), providing an effective means to realize the fabrication of composite biomimetic bone regeneration scaffolds. Therefore, using 3D printing technology to prepare organic-inorganic composite materials with controllable external morphology and internal structure, and to achieve biomimicry of material composition and structural morphology to improve osteogenic performance, is an important research direction in artificial bone preparation. In the embodiments of this application, the material of the scaffold body 10 is β-TCP and PCL. This is because β-TCP has good bioactivity and an adjustable degradation rate; polycaprolactone is a commonly used 3D printing material, and the combination of the two can improve the mechanical strength, biocompatibility, osteogenic induction, and biodegradability of the 3D printed scaffold.

[0049] In application, the functional composite scaffold provided in this application embodiment can be used to treat various diseases, and the specific application depends on the type of active nanoparticles. In this application embodiment, taking diabetic bone defect as a pathological condition, the functional composite scaffold provided in this application embodiment is used to solve the problems of unstable physicochemical properties, easy degradation in vivo and in vitro, low solubility, and poor bioavailability of antioxidant drugs, improve the sustained-release performance of drugs, thereby promoting bone angiogenesis and improving the therapeutic effect of repairing bone defects and regenerating bone.

[0050] Specifically, such as Figure 9 As shown, the active nanoparticles provided in this application include melatonin and PLGA. Melatonin (also known as melatonin hormone, pineal hormone, or melatonin), chemically named N-acetyl-5-methoxytryptamine, is an indoleamine hormone produced and secreted by pineal cells at night. It plays an important role in regulating the human circadian rhythm and sleep / wake cycle, and has received widespread attention due to its powerful antioxidant and anti-inflammatory effects. Furthermore, studies have found that melatonin has a direct promoting effect on bone mineralization and can maintain the balance of bone metabolism by inhibiting osteoclast activity, exhibiting antioxidant and anti-inflammatory effects. Simultaneously, melatonin protects vascular endothelial cells from oxidative stress damage through its antioxidant effects, promotes angiogenesis, and enhances angiogenesis-osteogenic coupling. However, as a strong antioxidant, melatonin suffers from poor chemical stability, low solubility, easy decomposition, low oral bioavailability, and a short half-life, thus limiting its clinical therapeutic effects. Polylactic acid-glycolic acid copolymers (PLGAs) are a class of biopolymers formed by the random polymerization of lactic acid and glycolic acid in different proportions. They possess excellent properties such as controllable degradability, good biocompatibility, and excellent plasticity. During degradation, PLGA nanoparticles gradually develop micropores on their surface, allowing the drug to be exposed on the nanoparticle surface and gradually dissolved and released, achieving a long-lasting sustained-release effect. The functionalized membrane material provided in this application embodiment is sodium alginate hydrogel, such as... Figure 8 The alginate shown is a linear polysaccharide composed of 1-4 linked β-D-mannuronic acid (M) and its epiomer α-L-guluronic acid (G). Its superior properties include in-situ gelation, water solubility, cell compatibility, prolonged release of active formulations, and a protective barrier for cell and particle release systems. When applied to the scaffold in the embodiments of this application, it can further enhance the biofunctionality and hydrophilicity of the 3D-printed scaffold material.

[0051] In applications, active nanoparticles are uniformly embedded within the functionalized film layer. In specific embodiments, they may be embedded on the surface of the functionalized film layer. This facilitates the timely release of the active nanoparticles.

[0052] Thus, the functional composite scaffold provided in this application uses biodegradable PLGA as a nanocarrier to encapsulate melatonin, constructing melatonin@PLGA active drug-carrying nanoparticles. These melatonin@PLGA active nanoparticles are then mixed with sodium alginate hydrogel and filled into the internal pores 100 of the 3D-printed PCL / β-TCP scaffold body 10, resulting in a PCL / β-TCP composite scaffold functionalized with melatonin@PLGA active nanoparticles. In the pathological environment of diabetic bone defects, as the sodium alginate hydrogel gradually degrades, melatonin is slowly released from the nanoparticles, clearing excess reactive oxygen species within bone vascular endothelial cells, protecting bone blood vessels from oxidative stress, and thereby promoting angiogenesis-bone regeneration coupling and exerting an osteogenic effect. Due to the retention effect of the hydrogel and the encapsulation effect of PLGA, the slow release of melatonin can be effectively achieved to match the bone regeneration process. Simultaneously, the nanoparticle carrier form can effectively improve the solubility and bioavailability of melatonin, further enhancing the therapeutic effect of the drug.

[0053] In some embodiments, such as Figures 1 to 6 As shown, in any two-layered frame 11, the columns 12 in one layer of frame 11 are arranged parallel to each other. That is, the two layers of frame 11, separated by one layer, have an identical layout design, which makes 3D printing of the entire stent body 10 easier and simplifies the design. In another embodiment, in any two-layered frame 11, the columns 12 in one layer of frame 11 are arranged at a predetermined angle to intersect each other. This arrangement allows for a greater variety of internal pores 100 in the stent body 10, resulting in more uniform distribution of the functionalized membrane layers within the pores 100, and consequently, a more uniform distribution of active nanoparticles, which is beneficial for improving the therapeutic effect of the functional composite stent.

[0054] In some embodiments, such as Figures 1 to 6 As shown, the preset angle is 30° to 90°. In a preferred embodiment, the preset angle is 90°. In another preferred embodiment, the preset angle is 60°. In other embodiments, the preset angle can also be any degree between 30° and 90°, such as 30° or 45°. This facilitates more convenient and faster parameter design of the scaffold body 10, and allows for a more rational structural distribution of the final scaffold body 10, enabling the formation of more pores 100, increasing the porosity of the scaffold body 10, and thus allowing for the loading of more active nanoparticles.

[0055] In some embodiments, such as Figures 1 to 6As shown, the length of the columns 12 in each layer of the frame 11 gradually decreases from the middle to both sides. The gradually varying lengths of the columns 12 better disperse the stress applied to the frame, avoiding stress concentration points and thus improving the overall structural stability and durability. This design mimics the gradual structure of natural bone, helping to better simulate the mechanical properties of natural bone and improving the biocompatibility and mechanical adaptability of the frame.

[0056] In applications, each column 12 can also be of equal length. This configuration simplifies design and manufacturing, making it easier to achieve consistency and repeatability when using manufacturing technologies such as 3D printing, thus reducing manufacturing errors. The simplified design and manufacturing process reduces production costs and improves economic efficiency. The uniformity of all column 12 lengths ensures a more even distribution of stress applied to the scaffold, avoiding localized stress concentrations and improving the overall structural stability and durability. The uniform distribution of elastic modulus and stiffness throughout the scaffold helps maintain a consistent mechanical environment, supporting new bone growth and remodeling. The uniformity of all column 12 lengths ensures a uniform porosity distribution throughout the scaffold, promoting uniform cell distribution and proliferation. Consistent pore size facilitates nutrient transport and metabolic waste removal, supporting long-term cell survival and function. The uniformity of all column 12 lengths ensures the uniform distribution of drugs or growth factors throughout the scaffold, achieving a more consistent release rate.

[0057] In some embodiments, in any two adjacent frames 11, the columns 12 in one frame 11 and the columns 12 in another frame 11 are in surface contact. In a preferred embodiment, as... Figure 5 As shown, the column 12 is a prism. In any two adjacent layers of the frame 11, the column 12 in one layer of the frame 11 is in surface contact with the column 12 in the other layer of the frame 11. This surface contact between the prisms 12 significantly increases the contact area, thereby improving the connection strength and stability between adjacent layers. This design effectively prevents the column 12 from sliding or tilting under stress, improving the rigidity and durability of the overall structure. Surface contact better disperses the stress applied to the support, avoiding stress concentration points, thus improving the mechanical properties and fatigue resistance of the support.

[0058] In other embodiments, such as Figure 6As shown, the column 12 is a prism 12. In any two adjacent layers of the frame 11, the column 12 in one layer of the frame 11 is in line contact with the column 12 in the other layer of the frame 11. This line contact between the prisms 12 reduces the contact area, thereby increasing the flexibility of the structure. This design allows the column 12 to have a certain degree of movement and deformation under stress, which helps to absorb and disperse impact forces and improve the impact resistance of the scaffold. The line contact design allows the scaffold to better adapt to defect areas of different shapes and sizes, expanding its application range in complex anatomical structures. Line contact can increase the porosity inside the scaffold, providing more open space, which is beneficial for cell migration and tissue regeneration. The porous network formed by line contact can promote the transport of nutrients and the removal of metabolic waste, supporting the long-term survival and function of cells.

[0059] In some embodiments, the pore size of pore 100 is 100 μm to 300 μm. In a preferred embodiment, the pore size of pore 100 is 200 μm. This is because pores 100 with a pore size of 100 μm to 300 μm can provide high porosity, which is beneficial for cell migration and tissue regeneration. Pores 100 within this pore size range provide sufficient space without being too sparse, thus affecting the mechanical properties of the scaffold.

[0060] In some embodiments, the porosity of the scaffold body 10 is 40% to 60%. A porosity of 40% to 60% provides sufficient pore space, which is beneficial for cell migration and tissue regeneration. This porosity range ensures sufficient pore space without making the scaffold structure too fragile.

[0061] In some embodiments, the support body 10 is generally cylindrical, prismatic, elliptical cylindrical, spherical, or ellipsoidal. In a preferred embodiment, the support body 10 is cylindrical. In one embodiment, the diameter of the support body 10 is 10 mm and the height is 2 mm.

[0062] In some embodiments, the stent body 10 is a 3D-printed one-piece structure. This 3D-printed one-piece structure ensures the integrity and uniformity of the stent, avoiding seams and connection points found in traditional manufacturing methods and reducing potential mechanical weaknesses. 3D printing technology allows for precise control of the size and shape of each component, ensuring structural consistency and improving manufacturing accuracy. Furthermore, 3D printing technology facilitates personalized designs, allowing stents to be customized according to the patient's specific needs and anatomical structure, thereby improving treatment outcomes.

[0063] In the above embodiments, the descriptions of each embodiment have different focuses. For parts that are not described in detail or recorded in a certain embodiment, please refer to the relevant descriptions of other embodiments.

[0064] The above-described embodiments are only used to illustrate the technical solutions of the embodiments of this application, and are not intended to limit them. Although the embodiments of this application have been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of this application, and should all be included within the protection scope of the embodiments of this application.

Claims

1. A functional composite stent, characterized in that, include: The support body includes multiple layers of frames stacked together. Each layer of the frame includes multiple parallel and spaced columns. In any two adjacent layers of the frame, the columns in one layer of the frame and the columns in the other layer of the frame are arranged to intersect at a preset angle, and the multiple columns form interconnected gaps. A functionalized film layer, connected to the column and filling the pores; and Active nanoparticles are embedded in the functionalized film layer.

2. The functional composite stent as described in claim 1, characterized in that, In any two-layered frame, the columns in one layer of the frame are arranged parallel to each other or intersecting at a preset angle with the columns in the other layer of the frame.

3. The functional composite stent as described in claim 2, characterized in that, The preset angle is 30° to 90°.

4. The functional composite stent as described in claim 1, characterized in that, The length of the column in each layer of the frame gradually decreases from the middle of the frame towards both sides; Alternatively, each of the aforementioned columns may have the same length.

5. The functional composite stent as described in claim 1, characterized in that, In any two adjacent frames, the columns in one frame and the columns in the other frame are in surface contact.

6. The functional composite stent as described in claim 1, characterized in that, The column is a prism, and in any two adjacent layers of the frame, the column in one layer of the frame and the column in the other layer of the frame are in line contact.

7. The functional composite stent as described in claim 1, characterized in that, The pore size is 100μm to 300μm.

8. The functional composite stent as described in claim 1, characterized in that, The porosity of the support body is 40% to 60%.

9. The functional composite stent as described in claim 1, characterized in that, The support body is generally cylindrical, prismatic, elliptical cylindrical, spherical, or ellipsoidal in shape. When the support body is cylindrical, the diameter of the support body is 10mm±1mm and the height is 2mm±0.2mm.

10. The functional composite stent according to any one of claims 1 to 9, characterized in that, The support body is a 3D printed one-piece structure.

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