CN110368136A - A kind of bionical stndon sheath film - Google Patents

A kind of bionical stndon sheath film Download PDF

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Publication number
CN110368136A
CN110368136A CN201910532724.3A CN201910532724A CN110368136A CN 110368136 A CN110368136 A CN 110368136A CN 201910532724 A CN201910532724 A CN 201910532724A CN 110368136 A CN110368136 A CN 110368136A
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layer
composite layer
fibrous layer
bag body
bag
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CN110368136B (en
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刘珅
范存义
蔡传栋
刘光旺
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Shanghai Sixth Peoples Hospital
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Shanghai Sixth Peoples Hospital
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/08Muscles; Tendons; Ligaments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14Macromolecular materials
    • A61L27/18Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14Macromolecular materials
    • A61L27/20Polysaccharides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58Materials at least partially resorbable by the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2400/00Materials characterised by their function or physical properties
    • A61L2400/12Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2430/00Materials or treatment for tissue regeneration
    • A61L2430/10Materials or treatment for tissue regeneration for reconstruction of tendons or ligaments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2430/00Materials or treatment for tissue regeneration
    • A61L2430/34Materials or treatment for tissue regeneration for soft tissue reconstruction

Abstract

The invention discloses a kind of bionical stndon sheath films, including fibrous layer and HA composite layer, it is characterized in that, four side compoiste adhering of fibrous layer and HA composite layer, free bag is placed between fibrous layer and HA composite layer, wherein the aperture of fibrous layer is less than the aperture of HA composite layer, the free bag is made of electrostatic spinning process, it includes bag body and drawstring, the aperture of bag body is less than the aperture of HA composite layer, the free bag list fixed pulling rope, drawstring has more, it is stretched out between fibrous layer and HA composite layer, it pulls drawstring to be able to drive bag body to move between fibrous layer and HA composite layer between fibrous layer and HA composite layer, bag body aperture ratio hyaluronan molecule diameter is big;It is provided with and cracks among HA composite layer, crack on the one hand for the hyaluronic acid that quickly circulates, on the other hand convenient for injecting hyaluronic acid to bag body, in addition, being also convenient for saying that free bag is put between two membranes.The bionical stndon sheath film can effectively improve the healing rate of big wound tendon, improve postoperative effect.

Description

A kind of bionical stndon sheath film
Technical field
The present invention relates to a kind of bionical stndon sheath films, and in particular to it is a kind of used in the operation on tendon sheath for be isolated stndon sheath with Tissue prevents adhesion, assists the bionical stndon sheath film of healing.
Background technique
Normal stndon sheath is the duplicature spline structure being made of the synovia layer of the fibrous layer of outer layer and internal layer.Fibrous layer is to prevent Effective biological containment of exogenous healing, and the synovia rich in hyaluronic acid of synovia layer secretion has nutrition tendon and promotes Its effect slided.Currently, class stndon sheath sample tissue has constructed success, and it is also regarded as and is had by the gel of HA building and film The physical barriers of lubricating action.But the shortcomings that class stndon sheath sample tissue, is that it can not secrete synovia, and constructed by hyaluronic acid Physical barriers retention time in vivo it is shorter, mechanical strength and stability are poor, it is difficult to it is long-term anti-to guarantee that it is played in vivo Adhesion effect.Therefore, in order to replicate the physiological structure and function of stndon sheath completely, it is necessary to which building can prevent external cellular or group from being woven in The barrier layer of film surface adherency, then be superimposed the load medicine internal layer for promoting healing process of tendons, not only with the tissue that prevents exogenous healing It is required that matching, also match with endogenous healing and the organizational requirements of tendon sliding is promoted.
Biomaterial is widely used in constructing bio-mechanical barrier with its good mechanical performance.Wherein, in polyethylene Ester (PCL) is widely used in biomedicine field because of its biological degradability and good stability.PCL can be reduced in peritonaeum The tentative confirmation of experiment has been obtained in the ability of adhesion.Currently, the more Antiadhesive film of research is with single layer nano fibrous membrane Main, the porosity of nano structure membrane is high and aperture is small, thus can be used as good pharmaceutical carrier.Therefore, PCL electrospun nanofiber Tunica fibrosa is expected to become pharmaceutical carrier, sustained release hyaluronic acid while as physical barriers.In addition, nano fibrous membrane While obstructing exogenous healing, the outer nutriment of sheath is allowed to enter the tendon broken ends of fractured bone by the film, to promote endogenous flesh Tendon healing.But due to hyaluronic acid is water-soluble substances and polyethylene lactone is oil soluble material, how two kinds of substances to be mixed Cooperation is that the PCL electro spinning nanometer fiber membrane of electrospun solution building load hyaluronic acid is that have problem to be solved.
The multilayered structure and sophisticated functions of stndon sheath are constructed, the layer structure to prevent adhesion and lubrication must be just existed simultaneously Endothecium structure, especially endothecium structure must have the biological function of secretion hyaluronic acid to lubricate tendon.Microgel electrostatic Spining technology is a new technology using nanofiber package micro-gel particles to make compound material.In the prior art Have and poly methyl methacrylate and poly n-isopropyl acrylamide are successfully packed in PCL superfine fibre.With based on poly- N- The electrostatic spinning technique of N-isopropylacrylamide makes crosslinked poly vinylpyrrolidone wrap up microgel, constructs mass percent For 40% microgel material.Therefore, using the microgel electrostatic spinning technique of HA and PCL, the PCL nanometer for carrying HA is respectively adopted Tunica fibrosa and internal layer and outer layer of the PCL nano fibrous membrane as bionical stndon sheath for not carrying HA, double-deck from bionics angle building Stndon sheath membrane structure, from the point of view of function, internal layer nanofiber simulates physiological HA secretion process to the controlled-release function of HA, The nano fibrous membrane of outer layer has played barrier action simultaneously, obstructs the exogenous healing of tendon.
Have composite bionic film (a kind of bionical stndon sheath film of CN201210585375.X and preparation method thereof) in the prior art During practice, the PCL nano fibrous membrane that HA is carried in discovery has that release HA rate is slower.
Summary of the invention
The purpose of the present invention is to provide one kind to discharge free hyaluronic acid and sustained release hyalomitome to stndon sheath and tissue The bionical stndon sheath film of acid.
To achieve the goals above, the present invention includes fibrous layer and HA composite layer, four Bian Fuhe of fibrous layer and HA composite layer Bonding places free bag between fibrous layer and HA composite layer, and wherein the aperture of fibrous layer is less than the aperture of HA composite layer, described Free bag is made of electrostatic spinning process comprising bag body and drawstring, the aperture of bag body are less than the aperture of HA composite layer, the trip From bag list fixed pulling rope, drawstring has more, stretches out between fibrous layer and HA composite layer, and drawstring is pulled to be able to drive bag body in fibre It is moved between dimension layer and HA composite layer between fibrous layer and HA composite layer, bag body aperture ratio hyaluronan molecule diameter is big;
Be provided with and crack among HA composite layer, crack on the one hand for quickly circulate hyaluronic acid, on the other hand convenient for Bag body injects hyaluronic acid, in addition, being also convenient for saying that free bag is put between two membranes.
Further, production technology is as follows:
Step 1, it prepares fibrous layer solution: degradable high polymer material being dissolved in organic solvent and forms mixed solution, Control 2-50 times that organic solvent quality is degradable high polymer material quality;
Step 2, it prepares HA composite layer solution: hyaluronic acid or its metal salt being completely dissolved, hyaluronic acid is made in water Or its metal salt gel, the quality for controlling water is 10-50 times of hyaluronic acid quality;Degradable high polymer material has been dissolved in Mixed solution A is formed in solvent, then that hyaluronic acid or its metal salt gel with mixed solution A be mixed to prepare stratum synoviale is molten Liquid, the content for controlling degradable high polymer material in stratum synoviale solution are less than or equal to 99.9wt%, degradable high polymer material Quality be 1-1000 times of hyaluronic acid or its metal salt quality;
Step 3, fibrous layer is made by electrostatic spinning process in fibrous layer solution, isolation film is laid on fibrous layer, every It is less than fibrous layer area, and four sides of exposed fiber layer from film leakage area;Electrostatic spinning process processing procedure HA is used on isolation film Composite layer, and HA composite layer four bonds while with fibrous layer four, it, will isolation before being finally near completion during electrostatic spinning Film sprays HA composite layer solution spray in Jiang Kaichu after extraction, answers HA from the extraction on one side for the fibrous layer for not receiving spinneret also The four sides bonding on four sides and fibrous layer of closing layer is compound;
Step 4, free bag is made in electrostatic spinning on matrix, and matrix includes intermediate, lateral plate, side piece, middle width It is the 1/3 of matrix width, lateral plate has two pieces close to middle, and width is identical as middle, and there are two side pieces, is located at lateral plate far from The side of piece, middle side it is fixed vertical with matrix width direction and with fixed link, lateral plate and side piece ipsilateral fixation and in The parallel fixed link of on piece fixed link, when making bag body using electrostatic spinning, the one side of bag body is made in the first spinneret on receiving platform, Retell matrix be placed on thereon, continue spinneret production bag body another side, spinning process first skip over fixed link position formed it is pre- Stay mouth, the width of reserved opening is greater than middle width, other parts all after the completion of, first middle is extracted out from reserved opening, Lateral plate and side piece are extracted out from reserved opening respectively, last spinneret seals reserved opening, the hollow bag body of closure is formed, finally in bag The side spinneret of body forms drawstring;
Step 5, in HA composite layer intermediate openings, free bag is filled between HA composite layer and fibrous layer, and drawstring is sharp It is pierced by with rigid posts from boundary between HA composite layer and fibrous layer.
Further, more on the both sides of fibrous layer or four sides in the step 3 when electrostatic spinning spinneret makes fibrous layer Print about 2-4mm wide adds layer.
Preferably, the free bag shape is kidney ellipsoid.
Preferably, the HA composite layer opening is cross or "-" type.
The beneficial effects of the present invention are, can be in the preoperative by placing free bag between HA composite layer and fibrous layer Hyaluronic acid will be loaded in free bag, so that the supply rate of hyaluronic acid needed for guaranteeing the biggish tendon of wound, accelerates big The healing rate of wound tendon.
Detailed description of the invention
Fig. 1 is HA lamination layer structure schematic diagram.
Fig. 2 is the status diagram that free bag is drawn out in Fig. 1.
Fig. 3 is free bag structural schematic diagram.
Fig. 4 is the left view of Fig. 3.
Fig. 5 is the side view of bionical stndon sheath film.
Fig. 6 is tunica fibrosa schematic diagram of a layer structure.
Fig. 7 is that free bag bottom surface and matrix cooperation electrostatic spinning form positive structural schematic diagram.
Fig. 8 is model piece structure schematic diagram.
Fig. 9 is matrix dispersity schematic diagram.
In figure, 10 fiber film layers, 11 plus layer, 20HA composite layer, 21 crack, 30 free bags, 31 bag bodies, 32 drawstrings, 33 pre- Stay mouth, 40 matrixs, 41 intermediates, 42 lateral plates, 43 side pieces.
Specific embodiment
Below in conjunction with attached drawing, the present invention will be described in detail.
The technique for preparing fiber film layer 10 and HA composite layer 20 is as follows:
Step 1, it prepares fibrous layer solution: degradable high polymer material being dissolved in organic solvent and forms mixed solution, Control 2-50 times that organic solvent quality is degradable high polymer material quality;
Step 2, prepare stratum synoviale solution: by hyaluronic acid or its metal salt be completely dissolved in water be made hyaluronic acid or Its metal salt gel, the quality for controlling water is 10-50 times of hyaluronic acid quality;Degradable high polymer material is dissolved in organic Mixed solution A is formed in solvent, then hyaluronic acid or its metal salt gel and mixed solution A are mixed to prepare stratum synoviale solution, The content for controlling degradable high polymer material in stratum synoviale solution is less than or equal to 99.9wt%, the matter of degradable high polymer material Amount is hyaluronic acid or 1-1000 times of its metal salt quality;
Step 3, fibrous layer solution and stratum synoviale solution be can be made into fibrous layer and stratum synoviale by electrostatic spinning process, And by the compound bionical stndon sheath film for obtaining double-layer structure of fibrous layer and stratum synoviale.Specifically such as:
The preparation of fibrous layer and HA composite layer the preparation method is as follows: weighing 2.4gPLC is dissolved in 7g tetrahydrofuran solution In, fibrous layer solution is made.
It weighs 0.1gHA and is dissolved completely in 1.5g water and form hyaluronic acid derivatives, while weighing 2.4gPL C and being dissolved in 7g tetra- In hydrogen tetrahydrofuran solution;Hyaluronic acid derivatives are added to the tetrahydrofuran solution of PCL, are mixed using eddy mixer, then plus Enter 2.5g hexafluoroisopropanol, mixed using eddy mixer, stratum synoviale solution (HA account for HA and PLC total amount 4%) is made.
Spinning is carried out in the method for electrostatic spinning to fibrous layer solution and stratum synoviale solution in succession and obtains the imitative of double-layer structure Raw stndon sheath film (PCL-HA4%), wherein Electrospinning parameters condition are as follows: voltage 30kV, flow velocity 0.04mL/min receive Platform is 15cm with a distance from spinning head.
Fibrous layer 10 and HA composite layer 20 can be obtained by electrospinning, finds HA composite layer in the actual operation process The rate for discharging hyaluronic acid is relatively low, and operation biggish for tendon wound loads the fibrous layer of HA, and hyaluronic acid is released It puts rate and does not catch up with wear rate, postoperative comfort level and healing effect are unsatisfactory.
Therefore, it is changed during through electrostatic spinning, the free of free hyaluronic acid can be packed by increasing Bag 30.
Its structure is, including fibrous layer 10 and HA composite layer 20,20 4 side compoiste adhering of fibrous layer 10 and HA composite layer, Free bag 30 is placed between fibrous layer 10 and HA composite layer 20, wherein the aperture of fibrous layer 10 is less than the aperture of HA composite layer 20, The free bag 30 is made of electrostatic spinning process comprising the aperture of bag body 31 and drawstring 32, bag body 31 is less than HA composite layer 20 aperture, the single fixed pulling rope 32 of the free bag 30, drawstring 32 have more, stretch between fibrous layer 10 and HA composite layer 20 Out, pull drawstring 32 be able to drive bag body 31 between fibrous layer 10 and HA composite layer 20 to fibrous layer 10 and HA composite layer 20 it Between move, 31 aperture ratio hyaluronan molecule diameter of bag body is big;
It is provided among HA composite layer 20 and cracks 21,21 one side of cracking are for the hyaluronic acid that quickly circulates, on the other hand Convenient for injecting hyaluronic acid to bag body 31, in addition, being also convenient for saying that free bag is put between two membranes.
In actual use, the vacant end of drawstring is located at except composite membrane, will first crack and 21 raise, by syringe to bag Hyaluronic acid is injected in body 31, then pulls drawstring, is said that bag body is pulled to the bonding part between two membranes, be can be avoided in this way The too fast outflow of hyaluronic acid.When in use, the tendon big for wound, due to the release speed of the hyaluronic acid in HA composite membrane Degree is slower, poor in the lubrication of early period and the effect of auxiliary healing.And this interior Biomimetic membranes for filling out free bag 30, after it has been gathered, Hyaluronic acid in free bag can the outside overflow from the hole and injection orifice of bag body 31, free hyalomitome is quickly provided Acid quickly provides hyaluronic acid at Wound healing initial stage, more effectively assists the healing of wound, avoids tissue adhesion.
The production process for having the bionical stndon sheath film of free bag is as follows:
Step 1, it prepares fibrous layer solution: degradable high polymer material being dissolved in organic solvent and forms mixed solution, Control 2-50 times that organic solvent quality is degradable high polymer material quality;
Step 2, it prepares HA composite layer solution: hyaluronic acid or its metal salt being completely dissolved, hyaluronic acid is made in water Or its metal salt gel, the quality for controlling water is 10-50 times of hyaluronic acid quality;Degradable high polymer material has been dissolved in Mixed solution A is formed in solvent, then that hyaluronic acid or its metal salt gel with mixed solution A be mixed to prepare stratum synoviale is molten Liquid, the content for controlling degradable high polymer material in stratum synoviale solution are less than or equal to 99.9wt%, degradable high polymer material Quality be 1-1000 times of hyaluronic acid or its metal salt quality;
Step 3, fibrous layer is made by electrostatic spinning process in fibrous layer solution, isolation film is laid on fibrous layer, every It is less than fibrous layer area, and four sides of exposed fiber layer from film leakage area;Electrostatic spinning process processing procedure HA is used on isolation film Composite layer, and HA composite layer four bonds while with fibrous layer four, it, will isolation before being finally near completion during electrostatic spinning Film sprays HA composite layer solution spray in Jiang Kaichu after extraction, answers HA from the extraction on one side for the fibrous layer for not receiving spinneret also The four sides bonding on four sides and fibrous layer of closing layer is compound;
Step 4, free bag 30 is made in electrostatic spinning on matrix 40, and matrix 40 includes 41 intermediates, 42 lateral plates, 43 sides Piece, middle 41 width are the 1/3 of 40 width of matrix, and lateral plate 42 has two pieces close to middle 41, and width is identical as middle, side piece There are two 43, positioned at lateral plate 42 far from middle 41 side, middle 41 sides it is fixed vertical with 40 width direction of matrix and with Fixed link, lateral plate 42 and side piece 43 fixed link parallel with middle on piece fixed link in ipsilateral fixation make bag using electrostatic spinning When body 31, the one side of bag body 31 is made in the first spinneret on receiving platform, is retell matrix 40 and is placed on thereon, and spinneret production bag body is continued Another side, spinning process first skip over fixed link position and form reserved opening 33, and the width of reserved opening 33 is greater than middle 41 width Degree, other parts all after the completion of, first middle 41 is extracted out from reserved opening 33, respectively by lateral plate 41 and side piece 42 from reserved Mouth extraction, last spinneret seal reserved opening, form the hollow bag body 31 of closure, are finally formed and are drawn in the side spinneret of bag body 31 Rope 32;
Step 5, in HA composite layer intermediate openings, free bag 30 is filled between HA composite layer 20 and fibrous layer 10, and will Using rigid posts, the boundary between HA composite layer 20 and fibrous layer 10 is pierced by drawstring 32.
In actual operation, bionical stndon sheath film is that the form of winding is coated on tendon, in this way, the flatness of film is to flesh The healing of tendon will generate large effect, if fold is more, peri-musculotendinous tissue can be grown with the shape of fold, be unfavorable for Functional rehabilitation after the healing in later period, and healing.
But the thickness of film is very thin, overall leveling extremely difficult, higher to the operation level requirement of performer, therefore, When electrostatic spinning spinneret makes fibrous layer, printing about 2-4mm's wide plus layer the both sides or four sides of fibrous layer more, so that The boundary of film is more slightly larger than internal hardness, is more convenient to operate when winding and evening up film.
The foregoing is merely the preferred embodiment of the present invention, are not intended to restrict the invention, for those skilled in the art For member, the invention may be variously modified and varied.All any modifications in spirit of that invention and principle, made are equal Replacement, improvement etc., should all be included in the protection scope of the present invention.

Claims (5)

1. a kind of bionical stndon sheath film, including fibrous layer and HA composite layer, which is characterized in that four Bian Fuhe of fibrous layer and HA composite layer Bonding places free bag between fibrous layer and HA composite layer, and wherein the aperture of fibrous layer is less than the aperture of HA composite layer, described Free bag is made of electrostatic spinning process comprising bag body and drawstring, the aperture of bag body are less than the aperture of HA composite layer, the trip From bag list fixed pulling rope, drawstring has more, stretches out between fibrous layer and HA composite layer, and drawstring is pulled to be able to drive bag body in fibre It is moved between dimension layer and HA composite layer between fibrous layer and HA composite layer, bag body aperture ratio hyaluronan molecule diameter is big;
It is provided with and cracks among HA composite layer, crack on the one hand for the hyaluronic acid that quickly circulates, be on the other hand convenient for bag body Hyaluronic acid is injected, in addition, being also convenient for saying that free bag is put between two membranes.
2. bionical stndon sheath film according to claim 1, which is characterized in that its production technology is as follows:
Step 1, it prepares fibrous layer solution: degradable high polymer material being dissolved in organic solvent and forms mixed solution, control Organic solvent quality is 2-50 times of degradable high polymer material quality;
Step 2, prepare HA composite layer solution: by hyaluronic acid or its metal salt be completely dissolved in water be made hyaluronic acid or its Metal salt gel, the quality for controlling water is 10-50 times of hyaluronic acid quality;Degradable high polymer material is dissolved in organic molten Mixed solution A is formed in agent, then hyaluronic acid or its metal salt gel and mixed solution A are mixed to prepare stratum synoviale solution, is controlled The content of degradable high polymer material is less than or equal to 99.9wt%, the quality of degradable high polymer material in stratum synoviale solution processed It is 1-1000 times of hyaluronic acid or its metal salt quality;
Step 3, fibrous layer is made by electrostatic spinning process in fibrous layer solution, isolation film, isolation film is laid on fibrous layer It leaks area and is less than fibrous layer area, and four sides of exposed fiber layer;It is compound using electrostatic spinning process processing procedure HA on isolation film Layer, and HA composite layer four bonds while with fibrous layer four, during electrostatic spinning, before last be near completion by isolation film from The extraction on one side for not receiving the fibrous layer of spinneret also sprays HA composite layer solution spray in Jiang Kaichu after extraction, makes HA composite layer Four sides and fibrous layer four sides bonding it is compound;
Step 4, free bag is made in electrostatic spinning on matrix, and matrix includes intermediate, lateral plate, side piece, and middle width is mould The 1/3 of piece width, lateral plate have two pieces close to middle, and width is identical as middle, and there are two side pieces, positioned at lateral plate far from middle Side, middle side it is fixed vertical with matrix width direction and with fixed link, lateral plate and side piece in ipsilateral fixation and middle on piece The parallel fixed link of fixed link, when making bag body using electrostatic spinning, the one side of bag body is made in the first spinneret on receiving platform, is retell Matrix is placed on the another side for continuing spinneret production bag body thereon, and spinning process first skips over fixed link position and forms reserved opening, The width of reserved opening is greater than middle width, other parts all after the completion of, middle is extracted out from reserved opening first, respectively will Lateral plate and side piece are extracted out from reserved opening, and last spinneret seals reserved opening, the hollow bag body of closure are formed, finally the one of bag body Side spray silk forms drawstring;
Step 5, in HA composite layer intermediate openings, free bag is filled between HA composite layer and fibrous layer, and by drawstring using firmly Matter bar is pierced by from boundary between HA composite layer and fibrous layer.
3. bionical stndon sheath film according to claim 2, which is characterized in that made in the step 3 in electrostatic spinning spinneret When fibrous layer, printing about 2-4mm's wide plus layer the both sides or four sides of fibrous layer more.
4. according to claim 1 to bionical stndon sheath film described in 3, which is characterized in that the free bag shape is kidney ellipsoid.
5. according to claim 1 to bionical stndon sheath film described in 3, which is characterized in that HA composite layer opening be cross or "-" type.
CN201910532724.3A 2019-06-19 2019-06-19 Bionic tendon sheath membrane Active CN110368136B (en)

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