Dense-hole type zinc alloy oral cavity film

Abstract

The utility model aims to provide a dense-hole type zinc alloy oral cavity membrane which structurally comprises a zinc alloy membrane and a fabric membrane, the fabric membrane covers the zinc alloy membrane, the zinc alloy membrane is formed by utilizing a powder metallurgy technology, can be wholly and completely degraded and can effectively keep effective support of metal to a shielding space, and the fabric membrane has micro-nano-level porosity, so that the shielding space can be effectively supported by the fabric membrane. And a multi-stage pore structure is formed by the porous part and the dense pore part of the zinc alloy, so that the exchange area with nutrient substances is increased, and the problem that the nutrient substances cannot penetrate through the metal film is solved.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of metal powder products, and particularly relates to a metal film prepared by additive manufacturing, and especially relates to a dense-pore zinc alloy oral film. BACKGROUND

[0002] The technology of guided bone regeneration (GBR) is to maintain space and block the growth of epithelial cells and fibroblasts with faster proliferation in the bone defect area by using fabric membranes, so as to ensure the dominant growth of osteoblasts with slower proliferation and form bone. The fabric membranes currently applied to GBR can be divided into bioabsorbable fabric membranes and non-absorbable fabric membranes according to the major categories. The non-absorbable fabric membranes are mostly porous membranes mainly made of titanium alloy. The metal membrane cannot effectively guide bone regeneration, and the metal surface is dense, so that the blood supply of the affected area is difficult to pass through the metal surface, greatly reducing the healing effect of the affected area. As for the absorbable fabric membrane, collagen membrane is most widely used in clinical application. The collagen membrane is mostly processed and produced based on biological materials, has good biocompatibility and certain bone regeneration induction, and has a large number of pores, which is beneficial to the healing of the affected area, but cannot effectively maintain the shielding space, affecting the use effect.

[0003] Moreover, the prior art usually does not composite the metal membrane with the collagen membrane. Since the metal surface is smooth, the collagen membrane is difficult to effectively adhere and is easy to fall off. In addition, the collagen membrane is produced by cross-linking collagen materials and is easy to be affected by temperature. In the process of cold storage and transportation, the collagen membrane will wrinkle due to thermal expansion and cold contraction. If the metal is directly composited with the collagen membrane, the metal will wrinkle or separate from the collagen membrane, affecting the use. CONTENT OF THE UTILITY MODEL

[0004] The utility model aims at providing a dense-pore zinc alloy oral film. The product is formed by powder metallurgy technology, can be completely degraded as a whole, can effectively maintain the effective support of the metal for shielding space, and increases the exchange area with nutrient substances through the micropores of the fabric membrane, overcoming the problem that the nutrient substances cannot pass through the metal membrane. In addition, the fabric structure of the fabric membrane is more stable and is less affected by temperature.

[0005] To achieve the above-mentioned purpose, the present application adopts the following technical effects:

[0006] A dense-pore zinc alloy oral film comprises a zinc alloy membrane and a fabric membrane. The fabric membrane is covered on the surface of the zinc alloy membrane. The fabric membrane is a textile / woven structure formed by stacking and weaving threads or wires, and has a porosity in the micron or nanometer level. The surface of the zinc alloy membrane is provided with a plurality of dense-pore portions. The pore diameter of the dense-pore portions is greater than the porosity of the fabric membrane. In use, the dense-pore portions maintain the shielding space of the bone defect site, and the fabric membrane limits the growth of soft tissues into the shielding space.

[0007] Furthermore, the fabric membrane is formed directly on the surface of the zinc alloy membrane using electrospinning technology, and the fabric membrane is located on one or both sides of the zinc alloy membrane. After implantation, the fabric membrane is located on the outward-facing side of the zinc alloy membrane.

[0008] Furthermore, in the fabric film, the fabric film has multiple layers; the number of multiple fabric film layers on both sides of the zinc alloy film may be different or the same.

[0009] Furthermore, in the fabric membrane, the porosity varies between different layers, with the porosity of the fabric membrane near the outer layer being less than that of the inner layer.

[0010] This application has at least the following beneficial effects.

[0011] (1) The composite structure is used to overcome the problem of insufficient bone induction of single metal materials; the zinc alloy film is set with dense pores and combined with the fabric film with lower porosity, which can not only solve the problem of poor shielding effect of dense pores, but also improve bone induction through multi-layer porous structure.

[0012] (2) The product is formed or assisted by additive manufacturing technology; unlike simple composites, the fabric membrane of this application has a woven or textile structure, which is stable and will not deform or shrink under conditions such as low temperature, sterilization, or bending. In addition, the porosity can be controlled by adjusting the process parameters.

[0013] (3) The product is biodegradable as a whole; the zinc alloy and the fabric membrane can be made of biodegradable materials, and no secondary surgery is required to remove it after implantation. Attached Figure Description

[0014] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0015] Figure 1 The schematic diagram illustrates a structural schematic of one embodiment of Example 1;

[0016] Figure 2 A schematic diagram illustrating another embodiment of Example 1 is shown.

[0017] Figure 3 A schematic cross-sectional view of Embodiment 1 is shown.

[0018] Wherein: 1-zinc alloy film, 2-fabric film, 3-pore portion. Specific Implementation

[0019] To provide a clearer understanding of the technical features, objectives, and effects of this invention, specific embodiments are now described in detail with reference to the accompanying drawings. In the following description, it should be understood that the orientations or positional relationships indicated by terms such as "front," "rear," "upper," "lower," "left," "right," "longitudinal," "horizontal," "vertical," "horizontal," "top," "bottom," "inner," "outer," "head," and "tail" are based on the orientations or positional relationships shown in the accompanying drawings, and are constructed and operated in a specific orientation. They are only for the convenience of describing this technical solution and do not indicate that the device or element referred to must have a specific orientation; therefore, they should not be construed as limitations on this invention.

[0020] In the following description, specific details such as particular system architectures and techniques are set forth for illustrative purposes and not for limitation, so as to provide a thorough understanding of the embodiments of the invention; however, those skilled in the art will understand that the invention may be implemented in other embodiments without these specific details. In other instances, detailed descriptions of well-known systems, apparatuses, and methods are omitted so as not to obscure the description of the invention with unnecessary detail. Example

[0021] A porous zinc alloy oral membrane includes: a zinc alloy membrane 1 and a fabric membrane 2, with the fabric membrane 2 covering both sides of the zinc alloy membrane 1 and the two tightly connected to form a whole; compared with traditional non-metallic membranes such as collagen membranes, the zinc alloy membrane 1 has higher strength, which is sufficient to form and effectively support the barrier space below it, and the fabric membrane 2 is also a biodegradable material, so the whole assembly is biodegradable and does not require secondary surgery to remove it; the zinc alloy membrane 1 adopts a porous design, which increases the channels for the exchange of external nutrients through the porous part 3, which is beneficial to the repair process of the affected area.

[0022] The porous portion 33 on the zinc alloy film 1 is evenly distributed across the entire surface of the zinc alloy film 1, such as... Figures 1-2 As shown, the pores are of the same size and evenly distributed on the zinc alloy film. Although the diameter of a single pore is not large, the combination of a large number of pores can greatly increase the pore area, thereby overcoming the inherent problem of metal films blocking nutrient pathways. Clearly, the pores on the zinc alloy film 1 can be either densely packed with small pores or, as shown, in other ways. Figure 2 The large holes shown can be flexibly adjusted according to the actual situation by those skilled in the art.

[0023] However, the above structure also has some problems. On the one hand, even with dense pores, endothelial cells can still grow into the bone defect through the pores, affecting bone tissue growth. On the other hand, the dense pore structure also reduces the strength of the zinc alloy film 1, which means that it can only be used alone in most cases. If it is directly combined with materials such as collagen film, the smooth metal surface is difficult to adhere stably. Moreover, the thermal expansion and contraction of the collagen film will cause the zinc alloy film 1 to wrinkle and become uneven.

[0024] This application effectively overcomes the above-mentioned problems by introducing the structure of fabric membrane 2. Unlike oral membranes made of biomaterials such as collagen membranes commonly used in the prior art, the fabric membrane 2 in this application is a textile or woven structure, which is formed by filaments or threads. It will not experience thermal expansion and contraction on a macroscopic scale. Moreover, it is a non-rigid structure with only a certain degree of elasticity, which can adapt to deformation. In addition, compared with structures such as collagen membranes, textile or woven structures not only naturally have a large number of gaps, but also can controllably form micron or even nano-sized pores by adjusting the filaments and processes. Collagen membranes, on the other hand, are difficult to control in terms of their porosity.

[0025] Fabric film 2 covers zinc alloy film 1, such as Figure 3 As shown, this is equivalent to covering the zinc alloy through holes with a denser pore layer, thereby overcoming the problem that the dense pores on the zinc alloy cannot effectively block the ingrowth of endothelial cells. Moreover, the shielding membrane and the through holes on the zinc alloy membrane 1 together form a multi-level structure with different porosities, which can induce bone ingrowth. In addition, the structurally stable fabric membrane 2 will not cause deformation of the zinc alloy membrane 1, keeping the zinc alloy membrane 1 flat.

[0026] Of course, the material of the fabric membrane 2 can be a combination of one or more biocompatible materials selected from polylactic acid, polyglycolic acid-lactide, polycaprolactone, polyamino acids, sodium alginate, gelatin, hyaluronic acid, and collagen, all of which are biodegradable materials.

[0027] In this application, the weaving / texturing structure of the fabric membrane 2 includes, but is not limited to: disordered weaving structure, plain weave structure, twill weave structure, and satin weave structure. As a preferred embodiment, this embodiment adopts a disordered weaving structure formed by electrospinning technology, which can make the porosity reach the micron or nanometer level. Example

[0028] In this embodiment, the fabric membrane 2 also has multiple layers, each with a different porosity, and the outer layer of the fabric membrane 2 has a smaller porosity than the inner layer. Example

[0029] A porous zinc alloy oral membrane includes a zinc alloy membrane 1 and a fabric membrane 2. The difference between the above structure and the previous embodiment is that the fabric membrane 2 only covers one side of the zinc alloy membrane 1, and the two are tightly connected to form a whole. The zinc alloy membrane is close to the bone defect, while the fabric membrane is located on the outside, blocking the ingrowth of endothelial cells. Example

[0030] A porous zinc alloy oral membrane has the following structure: a zinc alloy membrane 1, a fabric membrane 2, and an intermediate layer. The difference between this embodiment and the above embodiment is that there is an intermediate layer between the zinc alloy membrane 1 and the fabric membrane 2. The intermediate layer also has pores and, depending on the use, it also has the additional effects of carrying drugs and improving the adhesion between the fabric membrane 2 and the zinc alloy membrane 1. Example

[0031] The main difference between this embodiment and the above embodiments is that the zinc alloy film 1 in this application is replaced with other biodegradable metals, such as magnesium alloy.

Claims

1. A porous zinc alloy oral membrane, characterized in that: include: Zinc alloy film and fabric film, wherein the fabric film covers the surface of the zinc alloy film, and the fabric film is a textile / woven structure made of stacked and woven threads or filaments, with porosity in the micron or nanometer range; The zinc alloy film has several densely pored sections on its surface. The pore diameter of the densely pored sections is larger than that of the fabric film. During use, it maintains a shielding space for the bone defect site, while the fabric film restricts the ingrowth of soft tissue into the shielding space.

2. The porous zinc alloy oral membrane according to claim 1, characterized in that: The fabric membrane is formed directly on the surface of the zinc alloy membrane using electrospinning technology.

3. The porous zinc alloy oral membrane according to claim 1, characterized in that: The fabric membrane is located on one side of the zinc alloy membrane, and after implantation, the fabric membrane is located on the outward-facing side of the zinc alloy membrane.

4. The porous zinc alloy oral membrane according to claim 1, characterized in that: The fabric membrane is located on both sides of the zinc alloy membrane.

5. The porous zinc alloy oral membrane according to claim 1, characterized in that: The fabric membrane has multiple layers.

6. The porous zinc alloy oral membrane according to claim 5, characterized in that: The zinc alloy film has different numbers of multilayer fabric films on both sides.

7. The porous zinc alloy oral membrane according to claim 5, characterized in that: The number of multilayer fabric films on both sides of the zinc alloy film is the same.

8. The porous zinc alloy oral membrane according to claim 5, characterized in that: In the fabric membrane, the porosity of different layers is different, and the porosity of the fabric membrane near the outer side is smaller than that of the fabric membrane near the inner side.

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