CN110141398A - Preparation method of artificial ligament and products thereof - Google Patents
Preparation method of artificial ligament and products thereof Download PDFInfo
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- CN110141398A CN110141398A CN201910443812.6A CN201910443812A CN110141398A CN 110141398 A CN110141398 A CN 110141398A CN 201910443812 A CN201910443812 A CN 201910443812A CN 110141398 A CN110141398 A CN 110141398A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/08—Muscles; Tendons; Ligaments
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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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/26—Mixtures of macromolecular compounds
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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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/58—Materials at least partially resorbable by the body
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
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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
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/10—Materials or treatment for tissue regeneration for reconstruction of tendons or ligaments
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Abstract
The present invention relates to a kind of preparation methods of artificial ligament, and by Filamentous artificial material, with fried dough twist pigtail, twisting forms artificial ligament again with ropy is twisted into.The fried dough twist pigtail by Filamentous artificial material with 15-25 root for 1 beam, 3 beams are twisted one, then are woven to fried dough twist pigtail with 3-4 strands；The ropy that is twisted into is is 1 beam with Filamentous artificial material 15-25 root, and 3 beams are twisted one, and 3 strands are twisted 1 rope.The artificial ligament that artificial ligament weaving method of the invention obtains has an excellent mechanical performances, mechanical property relatively self ACL, and the tensile elongation of a ligament is better than self ACL.Artificial ligament braiding structure of the invention can guarantee that ligament meets respectively and maintain kneed front and back and complicated spin stabilization effect.
Description
Technical field
The invention belongs to medical material tech fields, are related to a kind of preparation method and products thereof of artificial ligament.
Background technique
As China's national power is growing and living standard improves, the incidence of ligament injury increases year by year.With most common
Anterior cruciate ligament (anterior cruciate ligament, ACL) damage for, the annual ligament injury number in China is protected
Estimation is kept 1,000 ten thousand or more.Anterior cruciate ligament is Knee intra-articular ligament, and shin bone and femur are linked up, control knee joint rotation
Turn and prevent that tibial plateau from excessively moving forward or femur moves back, the importance of function is to maintain and coordinate kneed stability
It maintains kneed performance to stablize, human body is helped to complete a variety of biggish movements of difficulty, there is important physiological function.It is long-term acute
Strong lower extremity movement or a variety of other factors can lead to Anterior Cruciate Ligament Ruptures.It can lead to knee joint after Anterior Cruciate Ligament Ruptures
Shakiness can cause articular cartilage, meniscus injury and osteoarthritis if being not treated in time because spraining repeatedly.Ligament injury
Effect of conservative treatment is bad, and the ACL self-healing ability being broken completely is low, and the overwhelming majority cannot restore.So clinically mostly
To rebuild ACL as orientation treatment, rebuilding graft used by ACL mainly includes self tendon, Heterogeneous tendon and artificial tough
Band.
The benefit of autograft is the complication for not rejecting, but can frequently result in donor site position, and is needed secondary
Operation；There are also the problems such as limited, materials position wound convalescence is longer of drawing materials；Allograft can avoid self wound, but
Its source is extremely limited, and there are the risks that hepatitis B, AIDS etc. infect disease, there is also immune rejection problems, after gradually by people
Replaced work ligament.Current clinically most commonly used artificial ligament is exactly LARS ligament (ligament advanced
Reinforcement system), by polyethylene terephthalate (polyethylene terephthalate, PET)
Fiber is made.But the structure height of PET molecule is symmetrical, low surface energy results in cell and is difficult to depend on and enter PET fiber
Inside, osteoinductive is poor, there is a problem of that graft and host's knitting are bad, and its bioactivity still cannot make us full
Meaning.Its mechanical property is not good enough to cause ligament braiding overstocked, and fibre gap is small, is equally unfavorable for surrounding tissue and grows into.This meeting at a specified future date
Cause bone road to expand, graft abrasion, interior fixed a series of problems, such as loosening, leads to operative failure, therefore reinforce artificial ligament
Tissue sample inductivity, it is crucial for promoting graft-host to become the healing of self sample.
Summary of the invention
In view of this, the purpose of the present invention is to provide preparation methods of a kind of artificial ligament and products thereof.
In order to achieve the above objectives, the invention provides the following technical scheme:
1. a kind of preparation method of artificial ligament, the preparation method is that by Filamentous artificial material with fried dough twist pigtail and twisting
At ropy, twisting forms artificial ligament again.
Further, the preparation method is that Filamentous artificial material is twisted into ropy with 1 fried dough twist pigtail and 2
Twisting forms artificial ligament again.
Further, the fried dough twist pigtail is four bursts of braidings.
Further, the fried dough twist pigtail is the round fried dough twist pigtail of four bursts of braidings.
Further, it with 15-25 root is 1 beam that the fried dough twist pigtail, which is Filamentous artificial material, and 3 beams are twisted one, then with
3-4 strands are woven to fried dough twist pigtail.
Further, it with 15-20 root is 1 beam that the fried dough twist pigtail, which is Filamentous artificial material, and 3 beams are twisted one, then with
3-4 strands are woven to fried dough twist pigtail.
Further, it with 20 is 1 beam that the fried dough twist pigtail, which is Filamentous artificial material, and 3 beams are twisted one, then with 3-4
Stock is woven to fried dough twist pigtail.
Further, for the ropy that is twisted into be 1 beam with Filamentous artificial material 15-25 root, 3 beams are twisted one
Stock, 3 strands are twisted 1 rope.
Further, for the ropy that is twisted into be 1 beam with Filamentous artificial material 15-20 root, 3 beams are twisted one
Stock, 3 strands are twisted 1 rope.
Further, for the ropy that is twisted into be 1 beam with Filamentous artificial material 15,3 beams are twisted one, and 3
Stock is twisted 1 rope.
Further, the artificial material of the filiform is I-type collagen, fibroin albumen, polyvinyl alcohol by raw material
It is prepared with chondroitin sulfate.
Further, it counts in mass ratio, I-type collagen in the raw material of Filamentous artificial material: fibroin albumen: poly-
Vinyl alcohol: chondroitin sulfate is 15~20:20~25:40~50:0.02~0.03.
Further, count in mass ratio, I-type collagen: fibroin albumen is 1:1~1.5.
Further, it counts in mass ratio, I-type collagen: fibroin albumen 1:1.
Further, wherein fibroin albumen the preparation method comprises the following steps: by silk at 100 DEG C of temperature, solid-liquid ratio 1:20~
Degumming 3 times in 30 Na2CO3 solution, each 30-40min remove sericin, obtain the fibroin albumen of degumming, then will acquire
Fibroin albumen be washed with deionized water, that drying to constant weight at 50-60 DEG C is spare.
Further, the artificial material of the filiform the preparation method comprises the following steps: fibroin albumen is dissolved in calcium chloride-ethyl alcohol-
Aqueous solution, is added polyvinyl alcohol, and chondroitin sulfate uniform stirring adds I-type collagen and be slowly stirred to after being completely dissolved
Spinning solution is formed to dissolution, regenerated fiber silk is prepared into using wet spinning technology.
Further, the meter of substance, calcium chloride: ethyl alcohol: water 1:2:8 are pressed in calcium chloride-ethanol-water solution.
Further, wet spinning technology are as follows: spinning solution squeezes into spinning head by pressure pump at 20-25 DEG C of room temperature；
The spinning solution come out from spinning head enters coagulating bath, and coagulating bath is 10% alcohol, solidifies slot length 1m；Spinning pressure
0.1MPa；Spinning rate 5-7mL/h；Wind rate 8-10r/min.
2. the artificial ligament obtained by the preparation method of any of the above item artificial ligament.
Further, the artificial ligament is ACL ligament.
The beneficial effects of the present invention are: regenerated fiber silk prepared by the present invention is by collagen and fibroin albumen group
At, filametntary histocompatbility is greatly improved, it is not only non-toxic for cell, also help its apposition growth；More
Be conducive to be easier to grow up to conducive to self ACL ligament sample cambium in vivo, and newborn after the artificial ligament transplanting of preparation
Tissue with ligament merge compared with closely.The artificial ligament histocompatbility of preparation is good, and 12 Zhou Hou outer layer synovial tissues are without increasing
There are new vessels to grow among thick and synovial membrane, it is good to absolutely prove that regenerated fiber silk provided by the present invention prepares artificial ligament energy
Formation natural ligament.Further the weaving of regenerated fiber silk is furtherd investigate, in conjunction with Mechanical test results, screening
Optimal basketry out；The mechanical property of artificial ligament is prepared relatively in provided weaving method through the invention
Self ACL, and the tensile elongation of a ligament is better than self ACL, the weaving method of this and fried dough twist pigtail has certain relationship, and another
2 strands be directly twisted rope form then limit its rigidity well.It is experimentally confirmed, regenerated fiber silk passes through first fried dough twist pigtail braiding
In conjunction with the artificial ligament being woven into after rope is directly twisted, has certain interior spatial structure, internal aperture reaches 40-
60nm, is conducive to cell migration and matrix is formed；And the round fried dough twist pigtail of four bursts of braidings improves maximum load, the two braiding
Cooperation have the function that disperse its pulling force, reduce the average diameter of artificial ligament, can satisfy the mechanics of preceding cross reconstruction
Demand.The artificial ligament of regenerated fiber silk of the present invention preparation has good mechanical performance and a slow degradability, degradation it is same
When do not cause the decline of organizational project ligament mechanical property.Artificial ligament braiding structure of the invention can guarantee that ligament is full respectively
Foot maintains kneed front and back and complicated spin stabilization effect.Artificial ligament provided by the present invention, with organizational project ACL and
LARS (Ligament Advanced Reinforcement System) compare have apparent advantage, without inoculating cell,
ACL Regeneration and Repair can be realized in simple artificial material implantation, simple and convenient.
Figure of description
In order to keep the purpose of the present invention, technical scheme and beneficial effects clearer, the present invention provides following attached drawing and carries out
Illustrate:
Fig. 1 is that round fried dough twist pigtail weaves step demonstration 1；
Fig. 2 is that round fried dough twist pigtail weaves step demonstration 2；
Fig. 3 is that round fried dough twist pigtail weaves step demonstration 3；
Fig. 4 is that round fried dough twist pigtail weaves step demonstration 4.
Specific embodiment
Following will be combined with the drawings in the embodiments of the present invention, and technical solution in the embodiment of the present invention carries out clear, complete
Site preparation description, it is clear that described embodiments are only a part of the embodiments of the present invention, instead of all the embodiments.Implement
Test method without specific conditions in example, usually according to conventional conditions or according to the manufacturer's recommendations.It is based on
Embodiment in the present invention, it is obtained by those of ordinary skill in the art without making creative efforts every other
Embodiment shall fall within the protection scope of the present invention.
The materials, reagents and the like used in the following examples is commercially available unless otherwise specified.
Quantitative test in following embodiment, is respectively provided with three repeated experiments, and data are the average value of three repeated experiments
Or mean+SD.
Embodiment 1
The preparation of silk fibroin protein solution:
By 200g silk temperature be 100 DEG C, 4-6L mass concentration be 1g/L Na2CO3 solution in degumming 3 times, often
Secondary 30-40min, remove sericin, obtain the fibroin albumen of degumming, then the fibroin albumen that will acquire be washed with deionized water,
It is spare that drying to constant weight at 50-60 DEG C.
Calcium chloride-alcohol-water (CaCl2-EtoH-H2O) solution is prepared according to the mass ratio of the material 1:2:8, by fibroin albumen
It is dissolved in calcium chloride-alcohol-water (CaCl2-EtoH-H2O) solution, it is molten to the fibroin albumen after degumming in 60 DEG C of thermostat water baths
4-5h is solved, after dissolution, 8 000-10000r/min of centrifuge is used after silk fibroin protein solution is cooled to room temperature, is centrifuged 5-10min,
Obtain silk fibroin protein solution.
Embodiment 2
At room temperature, take (quality volume fraction) silk fibroin protein solution of 100ml 20% that 50g polyvinyl alcohol, 30mg sulfuric acid is added
Chondroitin uniform stirring adds 20g I-type collagen and is slowly stirred to dissolution and form spinning solution to after being completely dissolved, and adopts
The preparation of regenerated fiber silk is carried out with wet spinning technology.Spinning technique are as follows: spinning solution passes through pressure pump at 20-25 DEG C of room temperature
Squeeze into spinning head；The spinning solution come out from spinning head enters coagulating bath, and coagulating bath is 10% alcohol, solidifies slot length 1m；It spins
Silk pressure 0.1MPa；Spinning rate 5mL/h；Wind rate 8r/min.By the comparison to spinning technology parameter, coagulating bath influences
Factor is maximum, followed by spinning speed, and pressure influence factor is minimum.It is tested and is surveyed by the alcohol coagulating bath of water and various concentration
Examination, it is best to the molding effect and performance of regenerated fiber silk when coagulating bath is 10% alcohol.Greater than the coagulating bath of 50% alcohol,
Molding effect difference cannot form.This embodiment is prepared into regenerated fiber silk and is named as NF1.
Embodiment 3
At room temperature, take (quality volume fraction) silk fibroin protein solution of 100ml 25% that 50g polyvinyl alcohol, 30mg sulfuric acid is added
Chondroitin uniform stirring adds 15g I-type collagen and is slowly stirred to dissolution and form spinning solution to after being completely dissolved, and adopts
The preparation of regenerated fiber silk is carried out with wet spinning technology.Spinning technique are as follows: spinning solution passes through pressure pump at 20-25 DEG C of room temperature
Squeeze into spinning head；The spinning solution come out from spinning head enters coagulating bath, and coagulating bath is 10% alcohol, solidifies slot length 1m；It spins
Silk pressure 0.1MPa；Spinning rate 5mL/h；Wind rate 8r/min.This embodiment is prepared into regenerated fiber silk and is named as NF2.
Embodiment 4
At room temperature, take (quality volume fraction) silk fibroin protein solution of 100ml 25% that 40g polyvinyl alcohol, 20mg sulfuric acid is added
Chondroitin uniform stirring adds 15g I-type collagen and is slowly stirred to dissolution and form spinning solution to after being completely dissolved, and adopts
The preparation of regenerated fiber silk is carried out with wet spinning technology.Spinning technique are as follows: spinning solution passes through pressure pump at 20-25 DEG C of room temperature
Squeeze into spinning head；The spinning solution come out from spinning head enters coagulating bath, and coagulating bath is 10% alcohol, solidifies slot length 1m；It spins
Silk pressure 0.1MPa；Spinning rate 5mL/h；Wind rate 8r/min.This embodiment is prepared into regenerated fiber silk and is named as NF3.
Embodiment 5
It is put into 24 orifice plates after artificial ligament material regeneration fiber filament prepared by embodiment 2-4 is sterilized, and PET fibre is set
Dimension group (the PET fiber silk that material adds same weight), (any material is not added) in blank control group, 3 repeat plates of every group of setting；It will
The 4 times of dilutions after 0.25% trypsin digestion, piping and druming are resuspended of the L-929 l cell of exponential phase of growth, are inoculated in
In each sample aperture, it is put into 37 DEG C, co-cultured in 5%CO2 incubator, culture medium is the DMEM of 10%FBS.It is training respectively
24 orifice plates are taken out after supporting 2,4 and 7d, 100ul CCK-8 reagent is added in every hole, continues after cultivating 4h, the solution in every hole is shifted
Into 96 hole elisa Plates, 100ul is added in every hole, and absorbance value, test result such as table are measured at wavelength 450nm using microplate reader
Shown in 1.And the proliferative conditions using inverted microscope observation L-929 cell in tissue culture plate and on each material.
1~7d of cell culture uses micro- sem observation l cell (L-929) proliferative conditions respectively.Cell training
It supports the 4th day, sees that blank control group cellular morphology is good in shuttle shape, growth conditions under microscope, proliferation to board bottom about 80% or more
Area；Material NF1, NF2 and NF3 group cellular morphology is in shuttle shape, and cell also has a large amount of proliferation, and form is normal, has on each material
It is on a small quantity in spindle cell apposition growth；PET fiber group cellular morphology is largely in shuttle shape, there is a small amount of proliferation, cell-free on material
Apposition growth.
Cell proliferation rate (RGR) %=(experimental group OD average value/blank control group OD average value) × 100%
Cytotoxicity classification: 0 grade, RGR >=100%；1 grade, 99% > RGR >=75%；2 grades, 74% > RGR >=50%；3
Grade, 49% > RGR >=25%；4 grades, 24% > RGR >=1%；5 grades, RGR is equal to 0%.
1 each group 2d, 4d and 7d Cell proliferation results of table and cytotoxicity classification grading
By table 1, it can be seen that, compared with blank control and the cell Proliferation of PET material co-cultivation is less, and with the time
Increase become apparent from.The cell had significant proliferation co-cultured with each regenerated fiber silk group is more, and RGR is 101%~113%, cell
Toxicity grading is 0, and explanation can be further prepared into artificial ligament no cytotoxicity, can be used for clinic.
Embodiment 6
It a. is 1 beam by regenerated fiber silk 20 prepared, 3 beams are twisted one, then take 4 strands to be woven into round fried dough twist
Pigtail；
It b. is 1 beam by regenerated fiber silk 20 prepared, 3 beams are twisted one, and 3 strands are twisted 1 rope；
C. 12, rope prepared with b step of the round fried dough twist pigtail for taking a step to prepare are twisted 1 again, are prepared as artificial
Ligament.
Wherein, the weaving method of round fried dough twist pigtail is as shown in attached drawing Fig. 1 to Fig. 4, successively tetra- strands of A, B, C, D, shown in Fig. 1,
It is divided into 2 groups of left and right, first with the line outside left side, removes the line for choosing right side the inside, i.e., gone to choose C strands with A-share, A-share pushes down C from above
Stock, shown in Fig. 2；Again with the line outside right side, the line for choosing left side the inside is removed, is i.e. turns left from above for D strands and chooses A-share, shown in Fig. 3；
Again with the line outside right side, the line for choosing left side the inside is removed, shown in Fig. 4；It constantly repeats the above steps, volume is to suitable length
Only.
The method is labeled as weaving method A.
Embodiment 7
It a. is 1 beam by regenerated fiber silk 15 prepared, 3 beams are twisted one, then take 4 strands to be woven into round fried dough twist
Pigtail；
It b. is 1 beam by regenerated fiber silk 15 prepared, 3 beams are twisted one, and 3 strands are twisted 1 rope；
C. 12, rope prepared with b step of the round fried dough twist pigtail for taking a step to prepare are twisted 1 again, are prepared as artificial
Ligament.
The method is labeled as weaving method B.
Embodiment 8
It a. is 1 beam by regenerated fiber silk 25 prepared, 3 beams are twisted one, then take 4 strands to be woven into round fried dough twist
Pigtail；
It b. is 1 beam by regenerated fiber silk 25 prepared, 3 beams are twisted one, and 3 strands are twisted 1 rope；
C. 12, rope prepared with b step of the round fried dough twist pigtail for taking a step to prepare are twisted 1 again, are prepared as artificial
Ligament.
The method is labeled as weaving method C.
Embodiment 9
It a. is 1 beam by regenerated fiber silk 20 prepared, 3 beams are twisted one, then take 4 strands to be woven into round fried dough twist
Pigtail；
It b. is 1 beam by regenerated fiber silk 15 prepared, 3 beams are twisted one, and 3 strands are twisted 1 rope；
C. 12, rope prepared with b step of the round fried dough twist pigtail for taking a step to prepare are twisted 1 again, are prepared as artificial
Ligament.
The method is labeled as weaving method D.
Embodiment 10
It a. is 1 beam by regenerated fiber silk 15 prepared, 3 beams are twisted one, then take 4 strands to be woven into round fried dough twist
Pigtail；
It b. is 1 beam by regenerated fiber silk 20 prepared, 3 beams are twisted one, and 3 strands are twisted 1 rope；
C. 12, rope prepared with b step of the round fried dough twist pigtail for taking a step to prepare are twisted 1 again, are prepared as artificial
Ligament.
The method is labeled as weaving method E.
Embodiment 11
It is 1 beam by regenerated fiber silk 20 prepared, 3 beams are twisted one, and 3 strands are twisted 1 rope, then 3 ropes are twisted
At 1 artificial ligament.
The method is labeled as weaving method F.
The above weaving method is applied equally to other Filamentous artificial materials, the artificial material be can be medical it is various
Material.Such as a kind of artificial ligament material that the preparation method of artificial ligament material obtains of 106048765 B of CN.Also such as CN
A kind of composite fibre that can be used for artificial ligament mentioned in 108728931 A.
Embodiment 12
Regenerated fiber silk NF1, NF2 and NF3 prepared by embodiment 2-4 is respectively according to embodiment 6-11 weaving method A-F
Weaving method be prepared into artificial ligament and carry out biocompatibility experiment, use 15 rabbits to carry out heterotopic transplantations.
Adult New Zealand rabbits 32 of health, it is (3 ± 0.50) kg that weight, which controls, female 16 heros 16, is randomly assigned,
But guarantee every kind of artificial ligament male and female each one.3% amobarbital is anaesthetized by 1.5ml/Kg dosage, by back after fixing on operating table
Carry out small range shaving, sterile lower operation, notch 3-4cm after the iodophor disinfection of shaving position, with tweezers and vessel forceps to two sides
Blunt separation subcutaneous tissue forms pouch spline structure；It is implanted into each artificial ligament to be sutured with absorbable suture again, each rabbit is carried out pair
It should mark, sterilize again, suture skin, and bandage dressing；Give within continuous 5 days intramuscular injection of penicillin prevention notch sense
Dye, frequency injection are 1 time/d, and whether there is or not inflammatory reactions for close observation notch part.12 weeks after operation is put to death rabbit and is observed.Pass through
The tough slide outer membrane tissue that takes that HE dyeing can clearly be observed that each implantation has among fibroblast and synovial membrane without thickening
There are new vessels to grow into.The tissue for having part newly-generated grows up to, similar self ACL ligament sample tissue, and cambium and ligament
Merge relatively closer.Obvious inflammatory reaction and tissue necrosis, each experimental animal have been had not seen in entire experimental test procedures
Also without other discomfort reactions.Illustrate that the biocompatibility of artificial ligament of the invention is good.
Embodiment 13
Regenerated fiber silk NF1, NF2 and NF3 prepared by embodiment 2-4 is respectively according to embodiment 6-11 weaving method A-F
Weaving method be prepared into artificial ligament carry out zoopery.And using self ACL as positive control.By woven artificial ligament
Stretching mechanical test is carried out with omnipotent mechanics tester.
Health adult New Zealand rabbits 54, weight control be (3 ± 0.50) kg, male and female each 30, sub-cage rearing.It will
Rabbit is randomly divided into group, every group 3, guarantees each experimental group at least male and female each one.When grouping to every rabbit row knee joint before
Drawer test and Lachman test feminine gender are to ensure that the preoperative knee joint function of experimental rabbit is normal.It is equal to experimental rabbit every
The double knee ACL of row are rebuild, and preoperative 3% amobarbital is anaesthetized by 1.5ml/Kg dosage, double knee joint preserved skin, disinfection.Rigorous aseptic item
Part downlink kneecap inner edge gonarthrotomy, successively cuts skin, articular cavity, and cut-out Infrapatellar fat pad intersects before exposure
First band completely cuts through self anterior cruciate ligament in the middle part of ligament, is bored respectively with the orthopaedic drill of the Kirschner wire drill bit equipped with 2.0mm
Femur and tibial bone tunnel are taken, and it is 45 ° that femur and tibial tunnel, which drill through angle, preparation is disinfected by draught line with steel wire
Artificial ligament pull in osseous tunnel.Graft end is fixed by cancellous bone screw deadman, and buckling position tenses artificial ligament, is tightened
Both ends screw.Postoperative rabbit separates independent rabbit-hutch and feeds, it is allowed to move freely.The dressing of the knee joint notch next day is simultaneously observed notch and is cured
Situation is closed, intramuscular injection of penicillin Incision infection prevention is given within continuous 5 days, frequency injection is 1 time/d.Daily to rabbit spirit shape
State, four limbs activity, diet and kneecap are whether there is or not to do careful observation situations such as dislocation, and go wrong timely processing.
Biomechanics test: Yu Shuhou puts to death every group of 3 rabbits for 20 weeks with air embolism method, and experiment is examined before execution
The double knee joint activity condition of rabbit, and carefully double knee joint row front drawer test and Lachman test are checked.In ligament tibia end
And femur end is truncated at knee joint 4cm, all soft tissues such as removal knee joint peripheral muscle, fascia only retain artificial
Ligament, Cement embed femur end and ligament tibia end respectively, femur-artificial ligament-shin bone complex sample are prepared into, by stock
Epiphysis and ligament tibia end are respectively placed in fixed on the fixture of electronic universal mechanics machine, adjustment osseous tunnel and direction of pull
Unanimously, the test of ultimate elongation mechanics is carried out.Firstly, applying 0-5N pulling force, speed 2mm/min is recycled 5 times, it is therefore an objective to by people
Work ligament tendon fiber all pulls open, and prevents the result that is tortuous and influencing Biomechanics test of tendon fiber.Again with 10mm/
The tensile speed of min applies drawing force until sample damage, true with the load-displacement curves that electronic universal mechanics machine is drawn
Determine the maximum load, rigidity, tensile elongation of artificial ligament.Test result is as shown in table 2.
Each ligament Mechanical test results of table 2
As shown in Table 2, using the mechanical property of the artificial ligament of weaving method E relatively self ACL, and a ligament
Tensile elongation be better than self ACL, the weaving method of this and fried dough twist pigtail has certain relationship, and another 2 strands are directly twisted rope form
Its rigidity is then limited well.It is experimentally confirmed, regenerated fiber silk passes through first fried dough twist pigtail braiding in conjunction with being directly twisted rope
The artificial ligament being woven into after son, has certain interior spatial structure, and internal aperture reaches 40-60nm, is conducive to cell and moves
It moves and matrix is formed；And the round fried dough twist pigtail of four bursts of braidings improves maximum load, and the cooperation of the two braiding, which reaches, disperses it
The effect of pulling force reduces the average diameter of artificial ligament, can satisfy the mechanics demand of preceding cross reconstruction.The present invention regenerates fine
The artificial ligament for tieing up silk preparation has good mechanical performance and slow degradability, and degradation while does not cause organizational project tough
Decline with mechanical property.Artificial ligament braiding structure of the invention can guarantee that ligament meets respectively and maintain kneed front and back
It is acted on complicated spin stabilization.
Gross examination of skeletal muscle
Each experimental group ACL has no that hydrops and synovial tissue's hyperplasia, fixing screw are in place in apparent articular cavity after rebuilding
It is firm, newborn ligament tissue is formed at the former position ACL, form, color are substantially the same as normal ACL.Contain in prepared artificial ligament
There is silk to obtain natural silk fibre structure by removing Collagen, further increase the biocompatibility of artificial ligament,
And be conducive to the adherency of cell, migration and increment.
Finally, it is stated that preferred embodiment above is only used to illustrate the technical scheme of the present invention and not to limit it, although logical
It crosses above preferred embodiment the present invention is described in detail, however, those skilled in the art should understand that, can be
Various changes are made to it in form and in details, without departing from claims of the present invention limited range.
Claims (10)
1. a kind of preparation method of artificial ligament, which is characterized in that the preparation method is that by Filamentous artificial material with fried dough twist
Twisting forms artificial ligament to pigtail again with ropy is twisted into.
2. the preparation method of artificial ligament according to claim 1, which is characterized in that the preparation method is that by Filamentous people
Work material with 1 fried dough twist pigtail and 2 be twisted into ropy again twisting form artificial ligament.
3. the preparation method of artificial ligament according to claim 2, which is characterized in that the fried dough twist pigtail is four bursts of braidings.
4. the preparation method of artificial ligament according to claim 2, which is characterized in that the fried dough twist pigtail is the circle of four bursts of braidings
Shape fried dough twist pigtail.
5. the preparation method of artificial ligament according to claim 1, which is characterized in that the fried dough twist pigtail is Filamentous artificial material
For material with 15-25 root for 1 beam, 3 beams are twisted one, then are woven to fried dough twist pigtail with 3-4 strands.
6. the preparation method of artificial ligament according to claim 4, which is characterized in that the fried dough twist pigtail is Filamentous artificial material
For material with 15-20 root for 1 beam, 3 beams are twisted one, then are woven to fried dough twist pigtail with 3-4 strands.
7. the preparation method of any one of -6 artificial ligaments according to claim 1, which is characterized in that described to be twisted into ropy
To be 1 beam with Filamentous artificial material 15-25 root, 3 beams are twisted one, and 3 strands are twisted 1 rope.
8. the preparation method of artificial ligament according to claim 7, which is characterized in that the artificial material of the filiform is by former material
Material is that I-type collagen, fibroin albumen, polyvinyl alcohol and chondroitin sulfate are prepared.
9. the preparation method of artificial ligament according to claim 8, which is characterized in that count in mass ratio, Filamentous artificial material
I-type collagen in the raw material of material: fibroin albumen: polyvinyl alcohol: chondroitin sulfate is 15~20:20~25:40~50:
0.02~0.03.
10. the artificial ligament obtained by the preparation method of any one of claim 1-9 artificial ligament.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN115444978A (en) * | 2022-09-14 | 2022-12-09 | 中国科学技术大学 | Bionic artificial ligament material and preparation method thereof |
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| CN103767806A (en) * | 2012-10-25 | 2014-05-07 | 苏州瑞世医疗科技有限公司 | Biological type degradable artificial ligament based on natural silk |
| CN104822867A (en) * | 2012-09-27 | 2015-08-05 | 安德烈亚斯·托伊舍尔 | Product made of native silk fibres |
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| US20090054982A1 (en) * | 2007-08-23 | 2009-02-26 | William Wayne Cimino | Elastic metallic replacement ligament |
| CN201154005Y (en) * | 2007-12-21 | 2008-11-26 | 南京大学医学院附属鼓楼医院 | Knee joint cruciate ligaments for medical service |
| CN101829356A (en) * | 2010-05-06 | 2010-09-15 | 东华大学 | Tissue engineering artificial tendon scaffold enhanced body and preparation method thereof |
| CN104822867A (en) * | 2012-09-27 | 2015-08-05 | 安德烈亚斯·托伊舍尔 | Product made of native silk fibres |
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| CN115444978A (en) * | 2022-09-14 | 2022-12-09 | 中国科学技术大学 | Bionic artificial ligament material and preparation method thereof |
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