Double-layer guided tissue regeneration membrane and preparation method thereof

A double-layer technology for guiding tissue regeneration, applied in the field of double-layer guiding tissue regeneration membrane and its preparation, can solve the problems of poor bone regeneration, uneven distribution of fibers, and inability to be absorbed by tissues

Active Publication Date: 2021-03-26
山东奥精生物科技有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Non-degradable materials mainly include polyacetal, polytetrafluoroethylene, silicone membrane, etc. Although these materials have good biocompatibility with tissues, they also have many disadvantages: 1. They cannot be absorbed by tissues and require Secondary surgery to remove the material increases the chance of trauma; 2. The non-absorbable membrane has a significant risk of early exposure, which may lead to wound infection and subsequent poor bone regeneration; 3. Due to its rigidity and hydrophobicity, the non-absorbable membrane is must be fixed with screws, etc.
Chinese patent application CN104474589A uses electrospinning technology to blend and spin raw materials with different in vivo degradation times through electrospinning technology, and obtains a double-layer film with a dense layer and a "potential loose layer"; the loose layer of this patent application is composed of two Composition of two polymers with different degradation rates, the control of the degradation rate of the loose layer needs to be controlled by regulating the content of the two polymers. The loose layer in this patent application has the following problems: (1) The content of the two polymers cannot be simply spun Filament rate or spinning solution concentration just can be controlled, and spinning rate and spinning solution concentration all can directly influence the diameter of fiber, promptly can affect the size of loose layer aperture and porosity, and this is unfavorable for obtaining the loose layer of stable performance; ( 2) The fiber distribution of the two polymers on the receiver is not necessarily uniform. During the degradation process, the loose layer may produce cavities, which is not conducive to the adhesion of cells. On the contrary, the loose layer will also degrade too slowly locally, which is not conducive to the crawling of cells.
Chinese patent application CN110420359A discloses a membrane for guiding tissue regeneration, comprising a dense layer facing the periosteum and a loose layer facing the bone defect area; the dense layer is made of type I collagen and has a smooth surface; the loose layer is made of type I collagen and Mineralized collagen nanoparticles are composited, and the interior is a porous structure; however, the flexibility and applicability of the dense layer of the patent application need to be further improved

Method used

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  • Double-layer guided tissue regeneration membrane and preparation method thereof
  • Double-layer guided tissue regeneration membrane and preparation method thereof
  • Double-layer guided tissue regeneration membrane and preparation method thereof

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preparation example Construction

[0061] In a second aspect, the present invention provides a method for preparing a double-layer guided tissue regeneration membrane, the method comprising the following steps:

[0062] S1. The preparation steps of the loose layer: formulating type I collagen into a collagen gel solution, and then freeze-drying to prepare the loose layer;

[0063] S2, the preparation step of dense layer: mix polycaprolactone solution and chitosan solution evenly, obtain PCL / CS electrospinning solution, use described PCL / CS electrospinning solution as spinning solution through electrospinning in step A dense layer is made on the surface of the loose layer made by S1, thus obtaining a double-layer composite film composed of a loose layer and a dense layer;

[0064] S3. Cross-linking the double-layer composite membrane obtained in step S2 to prepare a double-layer guided tissue regeneration membrane.

[0065]The present invention constructs a guided tissue regeneration membrane with a double-laye...

Embodiment 1

[0126] Step S1, the preparation of the loose layer, specifically includes:

[0127] Step S1-1, dissolving type I collagen in purified water to prepare a collagen gel solution, wherein the mass concentration of collagen is 0.1%;

[0128] Step S1-2, put the collagen gel solution obtained in S1-1 into a polytetrafluoroethylene plate, spread evenly, put it into a freeze dryer for freeze drying, and the freeze drying process is as follows:

[0129] (1) Cool down the clapboard to -10°C in advance;

[0130] (2) End point judgment is≤0.9Pa / 10min; End point judgment method: carry out manual end point judgment once every 10min, judge 3 times continuously;

[0131] Step S1-3: Trim the loose collagen sponge (sponge-like loose layer) prepared in S1-2, and fix it on a cylindrical rotating receiver wrapped with aluminum foil.

[0132] S2: Preparation of dense layer, specifically including:

[0133] S2-1: Preparation of spinning solution:

[0134] a. Weigh a certain mass of poly(ε-caprola...

Embodiment 2

[0152] Embodiment 2 is basically the same as Embodiment 1, the difference is:

[0153] In step S2-1, take 2.4mL of poly(ε-caprolactone) solution and 1mL of chitosan solution, stir and mix evenly to prepare PCL / CS electrospinning solution for subsequent use; wherein, poly(ε-caprolactone) The mass ratio of the poly(ε-caprolactone) contained in the lactone) solution to the chitosan contained in the chitosan solution was 4.5:1.

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Abstract

The invention relates to a double-layer guided tissue regeneration membrane and a preparation method thereof. The double-layer guided tissue regeneration membrane is prepared by cross-linking a compact layer and a loose layer which are compounded together; the compact layer is prepared by blending polycaprolactone and chitosan and then adopting an electrostatic spinning method; and the loose layeris prepared by freeze-drying type I collagen. The method comprises the following steps: preparing a collagen gel solution from the type I collagen, and freeze-drying to obtain the loose layer; uniformly mixing the polycaprolactone solution with the chitosan solution to obtain a PCL / CS electrospinning solution, and preparing a compact layer on the surface of the loose layer by taking the PCL / CS electrospinning solution as a spinning solution through an electrostatic spinning method, so as to obtain a double-layer composite membrane; and crosslinking the double-layer composite membrane to obtain the double-layer guided tissue regeneration membrane. The double layers of the prepared material are combined more firmly, and the mechanical property is obviously improved; the compact layer is made of nanoscale superfine fibers, a fiber structure of an extracellular matrix is simulated, cell growth is facilitated, and a barrier effect can be effectively achieved.

Description

technical field [0001] The invention belongs to the technical field of medical device materials, and in particular relates to a double-layer guided tissue regeneration membrane and a preparation method thereof. Background technique [0002] In oral surgery procedures, application of barrier membranes has become routine for guided bone regeneration (GBR), guided tissue regeneration (GTR) for periodontal and peri-implant bone defects, and bone augmentation procedures prior to or concurrently with implant placement . Guided tissue regeneration Membrane material is the core of repair management. It acts as a physical barrier to form and maintain a regeneration space above the defective tissue, promote cell migration and growth to form new tissue, and prevent connective tissue cells and epithelial cells from growing in. [0003] At present, the guided tissue regeneration materials widely used in clinic can be divided into two categories: non-degradable and biodegradable material...

Claims

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Application Information

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IPC IPC(8): D04H1/728D04H1/4382D04H3/02D04H3/005D04H13/00A61L27/40A61L27/24A61L27/20A61L27/18A61L27/50A61L27/58
CPCD04H1/728D04H1/4382D04H3/02D04H3/005D04H13/00A61L27/24A61L27/20A61L27/18A61L27/50A61L27/58D10B2509/00A61L2430/12C08L5/08C08L67/04
Inventor 崔云宋天喜仇志烨李良才胡艳丽朱金亮何志敏
Owner 山东奥精生物科技有限公司
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