CN112717208A - Composite multi-layer amnion material for preventing adhesion - Google Patents
Composite multi-layer amnion material for preventing adhesion Download PDFInfo
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- CN112717208A CN112717208A CN202011395387.7A CN202011395387A CN112717208A CN 112717208 A CN112717208 A CN 112717208A CN 202011395387 A CN202011395387 A CN 202011395387A CN 112717208 A CN112717208 A CN 112717208A
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- amnion
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/005—Ingredients of undetermined constitution or reaction products thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/148—Materials at least partially resorbable by the body
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- D—TEXTILES; PAPER
- D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
- D04H—MAKING TEXTILE FABRICS, e.g. FROM FIBRES OR FILAMENTARY MATERIAL; FABRICS MADE BY SUCH PROCESSES OR APPARATUS, e.g. FELTS, NON-WOVEN FABRICS; COTTON-WOOL; WADDING ; NON-WOVEN FABRICS FROM STAPLE FIBRES, FILAMENTS OR YARNS, BONDED WITH AT LEAST ONE WEB-LIKE MATERIAL DURING THEIR CONSOLIDATION
- D04H1/00—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres
- D04H1/40—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties
- D04H1/42—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties characterised by the use of certain kinds of fibres insofar as this use has no preponderant influence on the consolidation of the fleece
- D04H1/4326—Condensation or reaction polymers
- D04H1/435—Polyesters
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- D—TEXTILES; PAPER
- D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
- D04H—MAKING TEXTILE FABRICS, e.g. FROM FIBRES OR FILAMENTARY MATERIAL; FABRICS MADE BY SUCH PROCESSES OR APPARATUS, e.g. FELTS, NON-WOVEN FABRICS; COTTON-WOOL; WADDING ; NON-WOVEN FABRICS FROM STAPLE FIBRES, FILAMENTS OR YARNS, BONDED WITH AT LEAST ONE WEB-LIKE MATERIAL DURING THEIR CONSOLIDATION
- D04H1/00—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres
- D04H1/70—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres characterised by the method of forming fleeces or layers, e.g. reorientation of fibres
- D04H1/72—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres characterised by the method of forming fleeces or layers, e.g. reorientation of fibres the fibres being randomly arranged
- D04H1/728—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres characterised by the method of forming fleeces or layers, e.g. reorientation of fibres the fibres being randomly arranged by electro-spinning
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/424—Anti-adhesion agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/12—Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
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- Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Heart & Thoracic Surgery (AREA)
- Surgery (AREA)
- Vascular Medicine (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Textile Engineering (AREA)
- Materials For Medical Uses (AREA)
Abstract
The invention relates to the field, in particular to a composite multi-layer amniotic membrane material for preventing adhesion, which comprises fresh amniotic membrane subjected to freezing and vacuum drying treatment and having a water content range of 1-20%, epithelial cell layers and basement membrane layers containing collagen matrixes and various active proteins, and the like, wherein polycaprolactone fiber membranes are received on two surfaces of the freeze-dried amniotic membrane through a high-voltage electrostatic spinning technology to form a multi-layer composite amniotic membrane, and PCL fiber membranes are received on a single surface (epithelial cell surface or basement membrane surface) of the freeze-dried amniotic membrane to form a double-layer composite membrane. The amnion and other high molecular substances such as PCL and the like are blended to form the multilayer nanofiber by a high-voltage electrostatic spinning technology, so that the mechanical strength and hydrophobicity of the amnion substrate are improved, a growth factor slow release system which accords with a tendon healing period is constructed, the defects that an amnion product is easy to tear, low in mechanical strength, easy to slip in operation and the like are effectively overcome, and a new way is provided for the tendon adhesion problem to be solved urgently in clinic.
Description
Technical Field
The invention relates to the technical field of medical materials, in particular to a composite multi-layer amniotic membrane material for preventing adhesion.
Background
With social progress and industrial development, tendon injury caused by trauma is very common, tendon adhesion to surrounding tissues is the most common complication after tendon injury repair, so that no effective solution exists so far, and the problem to be solved in clinic is solved urgently. Through the intensive research on the mechanism of tendon adhesion formation, many methods and materials for preventing tendon adhesion have been explored. The application of physical barriers to block exogenous healing is the main method for preventing tendon adhesion at present, and non-biological materials applied in the early stage, such as silica gel, gold foil, autologous fascia and the like, have more defects and are gradually eliminated. Absorbable high molecular compounds widely used clinically at present, such as hyaluronic acid and derivatives thereof, chitosan, polyglycolic acid-polylactic acid complex, collagen-mucopolysaccharide and the like, have increased complications such as tendon necrosis, permanent foreign body residue and the like due to no permeability and obstruction of nutrient permeation. Amnion, a natural high molecular substance derived from organisms, is a semipermeable membrane, smooth, avascular, neural and lymphatic, contains rich active ingredients such as stroma, cell factors, enzymes and the like, and has a unique structure which makes the amnion an ideal biological material.
The fresh amnion can not be preserved for a long time, so the fresh amnion is not suitable for clinical routine use. The currently clinically used amniotic membrane products are subjected to cryopreservation treatment, can be preserved for a long time and can be immediately used, not only can the amniotic membrane structure be well preserved, but also various inherent growth factors of the amniotic membrane can be preserved, but the lyophilized amniotic membrane does not contain or has low cell activity, the clinical application potential of the amniotic membrane cannot be maximized, the fact that the lyophilized amniotic membrane is crisp in texture, lacks sufficient mechanical strength and is dissolved too fast to cause slippage is also found in clinical application, and in order to overcome the limitations of the amniotic membrane material, other materials need to be introduced or the morphological structure of the amniotic membrane needs to be changed to improve the strength, extensibility and proper hydrophobicity of the amniotic membrane, so that the maximum potential of the structural characteristics of the amniotic membrane tissue is exerted.
Disclosure of Invention
The invention aims to solve the defects that the amnion product quality is crisp, easy to tear, low in mechanical strength and easy to slip in the operation in the prior art, and provides a composite multi-layer amnion material for preventing adhesion.
In order to achieve the purpose, the invention adopts the following technical scheme:
a composite multi-layer amnion material for preventing adhesion comprises fresh amnion which is subjected to freezing and vacuum drying treatment and has the water content ranging from 1% to 20%, epithelial cell layers containing collagen matrixes and various active proteins, basement membrane and other layers, and polycaprolactone fiber membranes are received on two surfaces of the freeze-dried amnion through a high-voltage electrostatic spinning technology to form the multi-layer composite amnion.
Preferably, the lyophilized amniotic membrane receives PCL fiber membrane on one side (epithelial cell side or basal membrane side) to form a two-layer composite membrane.
Preferably, various parameters in the electrospinning process are adjusted.
Preferably, a polycaprolactone spinning solution is used in the electrospinning process.
Preferably, various attributes of the composite membrane, such as the concentration of polycaprolactone or other high molecular compounds, the viscosity of the spinning solution, the surface tension, the conductivity, the diameter of a needle, the flow rate, the voltage and the receiving distance, the diameter of the nanofiber, the porosity, the specific surface area, the hydrophilicity and the like, are adjusted and optimized.
The invention has the beneficial effects that: the invention blends the amnion and other high molecular substances such as PCL and the like into multilayer nanofiber by a high-voltage electrostatic spinning technology, improves the mechanical strength and hydrophobicity of the amnion substrate, constructs a growth factor slow release system which accords with the tendon healing period, effectively solves the defects of easy tearing, low mechanical strength, easy slippage in intraoperative application and the like of the amnion product, and provides a new way for the tendon adhesion which needs to be solved urgently in clinic.
Drawings
FIG. 1 is a schematic three-dimensional structure diagram of a composite multi-layer amniotic membrane material for preventing adhesion according to the present invention;
FIG. 2 is a schematic view of a tendon-wrapped adhesion-preventing structure of a composite multi-layer amniotic membrane material for preventing adhesion according to the present invention.
In the figure: 1 electrostatic spinning nanofiber membrane, 2 freeze-dried amnion and 3 tendon.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments.
Referring to fig. 1-2, a composite multi-layer amniotic material for preventing adhesion, which comprises a fresh amniotic membrane subjected to freezing and vacuum drying treatment and having a moisture content ranging from 1% to 20%, an epithelial cell layer containing a collagen matrix, a plurality of active proteins, a basement membrane and the like, and is characterized in that: through a high-voltage electrostatic spinning technology, polycaprolactone fiber membranes are received on two surfaces of the freeze-dried amnion to form a multi-layer composite amnion, and the PCL fiber membranes are received on a single surface (an epithelial cell surface or a substrate membrane surface) of the freeze-dried amnion to form a double-layer composite membrane.
The method comprises the steps of preparing a polycaprolactone spinning solution, a nanometer fiber, a polymer matrix, a polymer.
Obtaining fresh amnion: fresh placenta tissue is subjected to blunt separation between the amnion and chorion to obtain smooth and semitransparent fresh amnion, which is soaked in balanced salt solution containing penicillin and streptomycin and stored in a refrigerator at 4 ℃ for later use.
Preparing freeze-dried amnion: placing fresh amnion in a working chamber of a freeze dryer, pre-freezing for a plurality of hours at low temperature, starting a condensing chamber for refrigeration, enabling the temperature of a cold trap to reach-10 ℃ to-56 ℃, starting a vacuum pump, and carrying out vacuum freeze drying to reduce the water content to below 20%. The freeze-dried amnion is sterilized by cobalt 60 irradiation.
Preparing an electrostatic spinning amniotic membrane substrate nanofiber membrane: and preparing Polycaprolactone (PCL) spinning solution, and uniformly mixing the PCL spinning solution and the PCL spinning solution with a magnetic rod overnight. Various parameters such as ambient temperature and humidity are set, and the electrostatic spinning device is connected. And (3) putting the electrospinning solution into a syringe, adjusting the flow rate and the high voltage of the solution, and adjusting the receiving distance, so that the PCL fiber membranes are received on the two surfaces of the freeze-dried amnion. The prepared nanofiber membrane is placed in a vacuum container to be dried overnight for later use.
Example (b): after the smooth and semitransparent fresh amnion is obtained by blunt separation between the amnion and the chorion, the amnion is soaked for 20 minutes by balanced salt solution containing 50ug/ml penicillin and 50ug/ml streptomycin and is placed in a DMEM culture medium and stored in a refrigerator at 4 ℃ for standby. Placing fresh amnion in a working chamber of a freeze dryer, pre-freezing for 1-10 hours at 0-50 ℃, starting a condensation chamber for refrigeration to enable the temperature of a cold trap to reach-10-56 ℃, starting a vacuum pump, and carrying out vacuum freeze drying until the water content is 1-20%. The freeze-dried amnion is sterilized by cobalt 60 irradiation. And preparing Polycaprolactone (PCL) spinning solution, and uniformly mixing the PCL spinning solution and the PCL spinning solution with a magnetic rod overnight. The ambient temperature is set to be 25 ℃ and the humidity is set to be 60%, and the electrostatic spinning device is connected. Putting the electrospinning solution into a 2ml syringe with a needle head with the diameter of 0.7mm, adjusting the flow rate of the solution to be 3.0ml/h, the voltage to be 15 kV and the receiving distance to be 15 cm, and receiving PCL fiber membranes on two surfaces of the freeze-dried amnion. The prepared nanofiber membrane is placed in a vacuum container to be dried overnight for later use.
The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art should be considered to be within the technical scope of the present invention, and the technical solutions and the inventive concepts thereof according to the present invention should be equivalent or changed within the scope of the present invention.
In the description of the present invention, it is to be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", and the like, indicate orientations and positional relationships based on those shown in the drawings, and are used only for convenience of description and simplicity of description, and do not indicate or imply that the equipment or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be considered as limiting the present invention.
Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present invention, "a plurality" means two or more unless specifically defined otherwise.
Claims (5)
1. A composite multi-layer amnion material for preventing adhesion comprises fresh amnion which is processed by freezing and vacuum drying and has the water content ranging from 1 percent to 20 percent, epithelial cell layer containing collagen matrix, multiple active proteins, basement membrane and other layers, and is characterized in that: the two surfaces of the freeze-dried amnion receive polycaprolactone fiber membranes by a high-voltage electrostatic spinning technology to form a multilayer composite amnion.
2. The composite multi-layer amniotic membrane material for preventing adhesion according to claim 1, wherein the lyophilized amniotic membrane receives PCL fiber membrane on one side to form a two-layer composite membrane.
3. The composite multilayer amniotic material for preventing adhesion according to claim 1 or 2, wherein various parameters of the electrospinning process are adjusted.
4. The adhesion-preventing composite multi-layer amniotic material according to claim 3, wherein a polycaprolactone spinning solution is used in the electrospinning process.
5. The amniotic membrane material of claim 4, wherein the properties of the composite membrane such as the concentration of polycaprolactone or other polymers, the viscosity of the spinning solution, the surface tension, the conductivity, the diameter of the needle, the flow rate, the voltage and the receiving distance, the diameter of the nanofiber, the porosity, the specific surface area and the hydrophilicity are optimized.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011395387.7A CN112717208A (en) | 2020-12-03 | 2020-12-03 | Composite multi-layer amnion material for preventing adhesion |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202011395387.7A CN112717208A (en) | 2020-12-03 | 2020-12-03 | Composite multi-layer amnion material for preventing adhesion |
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| CN112717208A true CN112717208A (en) | 2021-04-30 |
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| CN202011395387.7A Pending CN112717208A (en) | 2020-12-03 | 2020-12-03 | Composite multi-layer amnion material for preventing adhesion |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107213516A (en) * | 2017-06-16 | 2017-09-29 | 卓阮医疗科技（苏州）有限公司 | A kind of thin layer composite tissue renovation material of stable mechanical property and preparation method thereof |
| CN107596447A (en) * | 2017-10-11 | 2018-01-19 | 广州新诚生物科技有限公司 | A kind of biological medicinal membrane with tissue repair function and preparation method thereof |
| CN109125799A (en) * | 2018-09-05 | 2019-01-04 | 张强 | GelMA hydrogel people takes off the preparation method of the three-dimensional double-deck auxiliary material of cell amnion |
| CN111962210A (en) * | 2020-06-22 | 2020-11-20 | 华南理工大学 | Polycaprolactone/methacryloylated elastin nanofiber composite membrane and preparation method and application thereof |
-
2020
- 2020-12-03 CN CN202011395387.7A patent/CN112717208A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107213516A (en) * | 2017-06-16 | 2017-09-29 | 卓阮医疗科技（苏州）有限公司 | A kind of thin layer composite tissue renovation material of stable mechanical property and preparation method thereof |
| CN107596447A (en) * | 2017-10-11 | 2018-01-19 | 广州新诚生物科技有限公司 | A kind of biological medicinal membrane with tissue repair function and preparation method thereof |
| CN109125799A (en) * | 2018-09-05 | 2019-01-04 | 张强 | GelMA hydrogel people takes off the preparation method of the three-dimensional double-deck auxiliary material of cell amnion |
| CN111962210A (en) * | 2020-06-22 | 2020-11-20 | 华南理工大学 | Polycaprolactone/methacryloylated elastin nanofiber composite membrane and preparation method and application thereof |
Non-Patent Citations (1)
| Title |
|---|
| CHUNJIE LIU等: "《Regulation of ERK1/2 and SMAD2/3 Path-ways by Multi-Functional Electrospun PCL-Amnion Core-Shell Nanofibrous Membranes for Prevention of Post-Surgical Tendon Adhesion 》", 《INTERNATIONAL JOURNAL OF NANOMEDICINE》 * |
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