CN115068689B - Bone filling bag, and preparation method and application thereof - Google Patents
Bone filling bag, and preparation method and application thereof Download PDFInfo
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- CN115068689B CN115068689B CN202210691191.5A CN202210691191A CN115068689B CN 115068689 B CN115068689 B CN 115068689B CN 202210691191 A CN202210691191 A CN 202210691191A CN 115068689 B CN115068689 B CN 115068689B
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- 238000011049 filling Methods 0.000 title claims abstract description 67
- 210000000988 bone and bone Anatomy 0.000 title claims abstract description 66
- 238000002360 preparation method Methods 0.000 title claims abstract description 14
- 239000011248 coating agent Substances 0.000 claims abstract description 65
- 238000000576 coating method Methods 0.000 claims abstract description 65
- 238000009941 weaving Methods 0.000 claims abstract description 24
- 108010022355 Fibroins Proteins 0.000 claims abstract description 20
- 229910052588 hydroxylapatite Inorganic materials 0.000 claims abstract description 20
- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 claims abstract description 20
- 108010049931 Bone Morphogenetic Protein 2 Proteins 0.000 claims abstract description 19
- 102100024506 Bone morphogenetic protein 2 Human genes 0.000 claims abstract description 19
- HTTJABKRGRZYRN-UHFFFAOYSA-N Heparin Chemical compound OC1C(NC(=O)C)C(O)OC(COS(O)(=O)=O)C1OC1C(OS(O)(=O)=O)C(O)C(OC2C(C(OS(O)(=O)=O)C(OC3C(C(O)C(O)C(O3)C(O)=O)OS(O)(=O)=O)C(CO)O2)NS(O)(=O)=O)C(C(O)=O)O1 HTTJABKRGRZYRN-UHFFFAOYSA-N 0.000 claims abstract description 15
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- 238000000034 method Methods 0.000 claims description 49
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- 239000002639 bone cement Substances 0.000 claims description 14
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims description 10
- 238000002791 soaking Methods 0.000 claims description 10
- 230000010355 oscillation Effects 0.000 claims description 9
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- 238000004519 manufacturing process Methods 0.000 claims description 8
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- 239000011777 magnesium Substances 0.000 claims description 7
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- 239000006185 dispersion Substances 0.000 claims description 6
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 claims description 5
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 claims description 5
- 229910052749 magnesium Inorganic materials 0.000 claims description 5
- 229910000029 sodium carbonate Inorganic materials 0.000 claims description 5
- 229910052725 zinc Inorganic materials 0.000 claims description 5
- 229910052712 strontium Inorganic materials 0.000 claims description 4
- CIOAGBVUUVVLOB-UHFFFAOYSA-N strontium atom Chemical compound [Sr] CIOAGBVUUVVLOB-UHFFFAOYSA-N 0.000 claims description 4
- 239000002612 dispersion medium Substances 0.000 claims description 3
- 239000007788 liquid Substances 0.000 claims description 3
- 206010061218 Inflammation Diseases 0.000 abstract description 4
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- 239000000243 solution Substances 0.000 description 64
- MUBZPKHOEPUJKR-UHFFFAOYSA-N Oxalic acid Chemical compound OC(=O)C(O)=O MUBZPKHOEPUJKR-UHFFFAOYSA-N 0.000 description 18
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 18
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- JEIPFZHSYJVQDO-UHFFFAOYSA-N iron(III) oxide Inorganic materials O=[Fe]O[Fe]=O JEIPFZHSYJVQDO-UHFFFAOYSA-N 0.000 description 3
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- HZAXFHJVJLSVMW-UHFFFAOYSA-N 2-Aminoethan-1-ol Chemical compound NCCO HZAXFHJVJLSVMW-UHFFFAOYSA-N 0.000 description 2
- 206010010214 Compression fracture Diseases 0.000 description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
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- AMXOYNBUYSYVKV-UHFFFAOYSA-M lithium bromide Chemical compound [Li+].[Br-] AMXOYNBUYSYVKV-UHFFFAOYSA-M 0.000 description 2
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Classifications
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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
- A61L27/28—Materials for coating prostheses
- A61L27/30—Inorganic materials
- A61L27/306—Other specific inorganic materials not covered by A61L27/303 - A61L27/32
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
- A61B17/8802—Equipment for handling bone cement or other fluid fillers
- A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
- A61B17/885—Tools for expanding or compacting bones or discs or cavities therein
- A61B17/8852—Tools for expanding or compacting bones or discs or cavities therein capable of being assembled or enlarged, or changing shape, inside the bone or disc
- A61B17/8855—Tools for expanding or compacting bones or discs or cavities therein capable of being assembled or enlarged, or changing shape, inside the bone or disc inflatable, e.g. kyphoplasty balloons
-
- 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
- A61L27/28—Materials for coating prostheses
- A61L27/30—Inorganic materials
- A61L27/32—Phosphorus-containing materials, e.g. apatite
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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
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- A61L27/34—Macromolecular materials
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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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- 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
- A61L27/54—Biologically active materials, e.g. therapeutic substances
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
- A61L2300/252—Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
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- A—HUMAN NECESSITIES
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- 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
- A61L2300/412—Tissue-regenerating or healing or proliferative 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
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
- A61L2300/606—Coatings
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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
- A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
Abstract
The invention provides a bone filling bag and a preparation method and application thereof, and relates to the technical field of medical appliances. The bone filling bag is mainly obtained by alternately weaving silk warps and wefts; the surface of the bone filling pouch is provided with a coating. The coating comprises a first coating and a second coating which are arranged in a stacked manner; the first coating is a metal doped hydroxyapatite coating; the second coating is a BMP-2 loaded silk fibroin/heparin coating. The bone filling bag has the advantages of ensuring enough mechanical property, improving the biocompatibility and biosafety of the bone filling bag, and preventing inflammatory reaction possibly generated when the bone filling bag is left in the body for a long time. The coating of the surface of the bone-filling pouch may further enhance the osteogenic capacity of the bone-filling pouch and promote bone healing.
Description
Technical Field
The invention relates to the technical field of medical appliances, in particular to a bone filling bag and a preparation method and application thereof.
Background
PVP (percutaneous vertebroplasty) and PKP (percutaneous kyphoplasty) are the primary means of clinical treatment of osteoporotic vertebral compression fractures, with bone cement filling being an important part of the process. However, the direct injection of bone cement is extremely prone to severe consequences of bone cement leakage, which may lead to damage to the nervous system.
Accordingly, the technology of loading bone cement using bone-filled sacks such as Vesselplasty (bone-filled vertebroplasty) and BFMCs (bone-filled mesh bag technology) has been emerging, and it is common to implant a sac into a damaged vertebral body first, then to directly pour bone cement into the sac, and by utilizing the packing property and proper porosity of the sac, a small amount of bone cement overflows from the mesh openings, flows into the trabecular space, and the remaining bone cement remains in the sac to replace the damaged vertebral body to restore the vertebral body height. However, currently existing bone-filling bags are made of polyethylene terephthalate (PET), and although they have good mechanical properties, they have poor biocompatibility, and the bags need to remain in the body for a long period of time, so that the selection of the materials of the bags and whether they possess the ability to regenerate bone and induce osteogenesis is important.
The conventional sac is tubular fabric prepared from terylene as a raw material in a weaving mode of weaving or knitting, only plays a role in loading bone cement in the treatment technology, has no better biocompatibility and has no capability of promoting bone regeneration and bone induction.
In view of this, the present invention has been made.
Disclosure of Invention
The invention aims to provide a bone filling bag, which aims to solve the technical problems that the bone filling bag in the prior art is poor in biocompatibility and does not have the capability of bone regeneration and osteogenesis induction.
In order to achieve the above object of the present invention, the following technical solutions are specifically adopted:
the first aspect of the invention provides a bone filling bag which is mainly obtained by alternately weaving silk warps and wefts; the surface of the bone filling bag is provided with a coating.
Optionally, the coating comprises a first coating and a second coating disposed in a stack.
Preferably, the first coating is located between the bone-filling pouch surface and the second coating.
Optionally, the first coating is a metal doped hydroxyapatite coating.
Preferably, the second coating is a BMP-2 loaded silk fibroin/heparin coating.
Optionally, the metal comprises at least one of zinc, magnesium, and strontium.
Preferably, the hydroxyapatite is nano hydroxyapatite.
The second aspect of the invention provides a method for preparing a bone filling bag, which comprises the steps of alternately weaving raw silk serving as warp yarn and cooked silk serving as weft yarn to obtain a woven bag, and forming a coating on the woven bag to obtain the bone filling bag.
Optionally, forming the coating on the woven pouch comprises the steps of:
step A: the woven bag is subjected to first soaking and first drying in a hydroxyapatite dispersion liquid doped with metal to obtain a woven bag with a first coating;
and (B) step (B): and C, soaking the woven bag with the first coating obtained in the step A in a silk fibroin/heparin solution for the second time, drying the woven bag for the second time, and vibrating the woven bag in a BMP-2 solution for the third time to obtain the bone filling bag.
Optionally, the fineness of the warp yarn comprises 2.2tex/12f or 3.3tex/12f.
Preferably, the fineness of the weft yarn comprises 2.2tex/12f, 2.3tex/12f or 2.4tex/12f.
Preferably, the weave of the woven pocket comprises a plain weave, a 2/2 twill weave, or a 3/1 twill weave.
Preferably, the method of drafting the woven bag during weaving comprises forward drafting.
Preferably, the double layer weft density of the woven pocket comprises 1300 roots/10 cm, 1350 roots/10 cm or 1400 roots/10 cm.
Preferably, the reed number of the knitting bag during knitting comprises 150 reed/10 cm, 145 reed/10 cm or 140 reed/10 cm.
Preferably, the beating-up speed of the woven bag during the weaving process is 30m/min-40m/min.
Preferably, the warp tension of the woven pocket during the weaving process is 1.69kg-1.79kg.
Alternatively, the dispersion medium of the metal-incorporated hydroxyapatite dispersion comprises a PBS solution.
Preferably, the PBS solution has a concentration of 0.5mg/ml to 1.5mg/ml.
Preferably, the time of the first soaking is 1.5h-3.5h.
Preferably, the temperature of the first drying is 50 ℃ to 70 ℃.
Preferably, the first drying time is 8h-20h.
Preferably, the temperature of the second drying is 75 ℃ to 85 ℃.
Optionally, the frequency of the oscillation is 45r/min-55r/min.
Preferably, the temperature of the oscillation is between 35 ℃ and 39 ℃.
Preferably, the time of the shaking is 3.5-4.5 h.
Preferably, the third drying is performed in the vacuum drying oven.
Preferably, the temperature of the third drying is 50 ℃ to 70 ℃.
Preferably, the third drying time is 20-40min.
Alternatively, the concentration of the silk fibroin/heparin solution is 1.5mg/ml to 2.5mg/ml.
Preferably, the BMP-2 solution has a concentration of 1.5mg/ml to 2.5mg/ml.
Preferably, the BMP-2 solution has a pH of 8 to 9.
Preferably, the method further comprises a degumming step of the woven bag after the step A and before the step B.
Preferably, the degumming is carried out in a sodium carbonate solution having a concentration of 0.05wt.% to 0.10wt.%.
A third aspect of the invention provides the use of the bone-filling pouch in loading bone cement.
Compared with the prior art, the invention has at least the following beneficial effects:
the warp and weft yarns in the bone filling bag provided by the invention are woven by silk, so that the biocompatibility and biosafety of the bone filling bag are improved while the sufficient mechanical property is ensured, and the possible inflammatory reaction of the bone filling bag left in the body for a long time is prevented. The coating of the surface of the bone-filling pouch may further enhance the osteogenic capacity of the bone-filling pouch and promote bone healing.
The preparation method of the bone filling bag provided by the invention has compact and continuous process links and moderate cost, and is suitable for large-scale industrial production.
The application of the bone filling bag in bone cement loading is that the bone filling bag which has better affinity with human body and no immune rejection reaction is provided for clinic, the bone filling bag has no toxic effect on human body, the bone filling bag replaces the damaged part to support the vertebral body to restore height after bone cement is loaded, and the restoration of patients is promoted.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are needed in the description of the embodiments or the prior art will be briefly described, and it is obvious that the drawings in the description below are some embodiments of the present invention, and other drawings can be obtained according to the drawings without inventive effort for a person skilled in the art.
FIG. 1 is a plan view showing a weave structure of a woven bag according to embodiment 1 of the present invention;
FIG. 2 is a 2/2 diagonal upper machine chart of the woven bag weave structure provided by embodiment 2 of the invention;
fig. 3 is a 3/1 twill weave pattern for a woven bag according to embodiment 3 of the present invention.
Detailed Description
The technical solutions of the present invention will be clearly and completely described in connection with the embodiments, and it is apparent that the described embodiments are some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
The first aspect of the invention provides a bone filling bag which is mainly obtained by alternately weaving silk warps and wefts; the surface of the bone filling bag is provided with a coating.
The warp and weft yarns in the bone filling bag provided by the invention are woven by silk, so that the biocompatibility and biosafety of the bone filling bag are improved while the sufficient mechanical property is ensured, and the possible inflammatory reaction of the bone filling bag left in the body for a long time is prevented. The coating of the surface of the bone-filling pouch may further enhance the osteogenic capacity of the bone-filling pouch and promote bone healing.
Optionally, the coating comprises a first coating and a second coating disposed in a stack.
Preferably, the first coating is located between the bone-filling pouch surface and the second coating.
Optionally, the first coating is a metal doped hydroxyapatite coating.
Preferably, the second coating is a BMP-2 loaded silk fibroin/heparin coating.
The silk fibroin/heparin coating loaded with BMP-2 continuously releases BMP-2, enhances the osteoinductive capacity of bone capsular bag, promotes differentiation and migration of osteoblasts, and reduces the production of macrophages and inflammatory factors.
Optionally, the metal comprises at least one of zinc, magnesium, and strontium.
In some embodiments of the invention, the metal is typically, but not limited to, zinc, magnesium, or strontium.
Preferably, the hydroxyapatite is nano hydroxyapatite.
The nano hydroxyapatite coating doped with bioactive ions enables the silk woven structure bone filling bag to further enhance the osteogenesis capability of the bone bag, and is beneficial to bone regeneration of the osteoporosis vertebral compression fracture.
The second aspect of the invention provides a method for preparing a bone filling bag, which comprises the steps of alternately weaving raw silk serving as warp yarn and cooked silk serving as weft yarn to obtain a woven bag, and forming a coating on the woven bag to obtain the bone filling bag.
The preparation method of the bone filling bag provided by the invention has compact and continuous process links and moderate cost, and is suitable for large-scale industrial production.
Optionally, the method further comprises a cleaning process after the woven bag is obtained and before the coating is formed, so that rust, chemical residues and other impurities introduced by the bone filling bag during the weaving process are removed.
Preferably, the solution used for the washing is oxalic acid with a concentration of 1wt.% to 15wt.%, and is washed in a thermostatic water bath at a temperature of 70 ℃ for 30min.
In some embodiments of the invention, the concentration of oxalic acid is typically, but not limited to, 1wt.%, 3wt.%, 5wt.%, 7wt.%, 9wt.%, 11wt.%, 13wt.%, or 15wt.%.
Preferably, the method further comprises the step of cleaning in purified water after the rust is cleaned by oxalic acid, so that oxalic acid is further removed.
Optionally, after oxalic acid is cleaned, the surface of the woven bag can be further cleaned by deep washing for 20min in distilled water by using an ultrasonic cleaner to remove chemical residues and other impurities.
Optionally, forming the coating on the woven pouch comprises the steps of:
step A: the woven bag is subjected to first soaking and first drying in a hydroxyapatite dispersion liquid doped with metal to obtain a woven bag with a first coating;
and (B) step (B): and C, soaking the woven bag with the first coating obtained in the step A in a silk fibroin/heparin solution for the second time, drying the woven bag for the second time, and vibrating the woven bag in a BMP-2 solution for the third time to obtain the bone filling bag.
Optionally, the fineness of the warp yarn comprises 2.2tex/12f or 3.3tex/12f.
Preferably, the fineness of the weft yarn comprises 2.2tex/12f, 2.3tex/12f or 2.4tex/12f.
Preferably, the weave of the woven pocket comprises a plain weave, a 2/2 twill weave, or a 3/1 twill weave.
Preferably, the method of drafting the woven bag during weaving comprises forward drafting.
Preferably, the double layer weft density of the woven pocket comprises 1300 roots/10 cm, 1350 roots/10 cm or 1400 roots/10 cm.
Preferably, the reed number of the knitting bag during knitting comprises 150 reed/10 cm, 145 reed/10 cm or 140 reed/10 cm.
Preferably, the beating-up speed of the woven bag during the weaving process is 30m/min-40m/min.
In some embodiments of the present invention, the beat-up speed is typically, but not limited to, 30m/min, 32m/min, 34m/min, 36m/min, 38m/min, or 40m/min.
Preferably, the warp tension of the woven pocket during the weaving process is 1.69kg-1.79kg.
In some embodiments of the invention, the warp tension is typically, but not limited to, 1.69kg, 1.70kg, 1.71kg, 1.72kg, 1.73kg, 1.74kg, 1.76kg, or 1.79kg.
Alternatively, the dispersion medium of the metal-incorporated hydroxyapatite dispersion comprises a PBS solution.
Preferably, the PBS solution has a concentration of 0.5mg/ml to 1.5mg/ml.
In some embodiments of the invention, the concentration of the PBS solution is typically, but not limited to, 0.5mg/ml, 0.6mg/ml, 0.7mg/ml, 0.8mg/ml, 0.9mg/ml, 1mg/ml, 1.1mg/ml, 1.2mg/ml, 1.3mg/ml, 1.4mg/ml, or 1.5mg/ml.
Preferably, the time of the first soaking is 1.5h-3.5h.
In some embodiments of the invention, the first soaking time is typically, but not limited to, 1.5 hours, 2 hours, 2.5 hours, 3 hours, or 3.5 hours.
Preferably, the temperature of the first drying is 50 ℃ to 70 ℃.
In some embodiments of the invention, the temperature of the first drying is typically, but not limited to, 50 ℃, 55 ℃,60 ℃, 65 ℃ or 70 ℃.
Preferably, the first drying time is 8h-20h.
In some embodiments of the invention, the first drying time is typically, but not limited to, 8h, 10h, 12h, 14h, 16h, 18h, or 20h.
Preferably, the temperature of the second drying is 75 ℃ to 85 ℃.
In some embodiments of the invention, the temperature of the second drying is typically, but not limited to, 75 ℃, 77 ℃, 79 ℃, 83 ℃, or 85 ℃.
Optionally, the frequency of the oscillation is 45r/min-55r/min.
In some embodiments of the invention, the frequency of the oscillation is typically, but not limited to, 45r/min, 47r/min, 49r/min, 51r/min, 53r/min or 55r/min.
Preferably, the temperature of the oscillation is between 35 ℃ and 39 ℃.
In some embodiments of the invention, the temperature of the oscillation is typically, but not limited to, 35 ℃, 36 ℃, 37 ℃, 38 ℃, or 39 ℃.
Preferably, the time of the shaking is 3.5-4.5 h.
In some embodiments of the invention, the time of the oscillation is typically, but not limited to, 3.5h, 3.7h, 3.9h, 4.1h, 4.3h, or 4.5h.
Preferably, the third drying is performed in the vacuum drying oven.
Drying in a vacuum drying oven ensures the safety and sanitation of the bone filling bag and avoids secondary pollution.
Preferably, the temperature of the third drying is 50 ℃ to 70 ℃.
In some embodiments of the invention, the temperature of the third drying is typically, but not limited to, 50 ℃, 55 ℃,60 ℃, 65 ℃ or 70 ℃.
Preferably, the third drying time is 20-40min.
In some embodiments of the invention, the third drying time is typically, but not limited to, 20 minutes, 30 minutes, or 40 minutes.
Alternatively, the concentration of the silk fibroin/heparin solution is 1.5mg/ml to 2.5mg/ml.
In some embodiments of the invention, the concentration of the silk fibroin/heparin solution is typically, but not limited to, 1.5mg/ml, 1.7mg/ml, 1.9mg/ml, 2.1mg/ml, 2.3mg/ml, or 2.5mg/ml.
Preferably, the BMP-2 solution has a concentration of 1.5mg/ml to 2.5mg/ml.
In some embodiments of the invention, the BMP-2 solution is typically, but not limited to, 1.5mg/ml, 1.7mg/ml, 1.9mg/ml, 2.1mg/ml, 2.3mg/ml, or 2.5mg/ml in concentration.
Preferably, the BMP-2 solution has a pH of 8 to 9.
In some embodiments of the invention, the BMP-2 solution typically has a pH of, but not limited to, 8, 8.2, 8.4, 8.6, 8.8 or 9.
Preferably, the method further comprises a degumming step of the woven bag after the step A and before the step B.
The raw silk is composed of two proteins, the inner layer is silk fibroin, and the outer layer is coated by sericin. The silk fibroin is 70% -80%, contains 18 human absorbable amino acids, and has the special performance of amphoteric charge, no toxicity, good human affinity, biodegradability and biocompatibility. In order to avoid inflammatory reactions that occur after the bone-filled pouch is implanted in the human body, it is necessary to remove sericin from the surface of the raw silk.
Preferably, the degumming is carried out in a sodium carbonate solution having a concentration of 0.05wt.% to 0.10wt.%.
In some embodiments of the invention, the concentration of the sodium carbonate solution is typically, but not limited to, 0.05wt.%, 0.06wt.%, 0.07wt.%, 0.08wt.%, 0.09wt.%, or 0.10wt.%.
Preferably, the degumming temperature is from 90 ℃ to 100 ℃.
In some embodiments of the invention, the degumming temperature is typically, but not limited to, 90 ℃, 92 ℃, 94 ℃, 96 ℃, 98 ℃ or 100 ℃.
Preferably, the degumming process is carried out for 20min in one period, and distilled water at 60 ℃ is used for repeatedly scrubbing and removing sericin after each period is completed, so that the degumming effect is improved.
Preferably, the method further comprises a heat setting process after degumming.
Preferably, the temperature of the heat setting is 120 ℃ to 130 ℃.
In some embodiments of the invention, the temperature of the heat setting is typically, but not limited to, 120 ℃, 122 ℃, 124 ℃, 126 ℃, 128 ℃, or 130 ℃.
Preferably, the time for heat setting is 30min-60min.
In some embodiments of the invention, the time for heat setting is typically, but not limited to, 30min, 40min, 50min, or 60min.
A third aspect of the invention provides the use of the bone-filling pouch in loading bone cement.
The application of the bone filling bag in bone cement loading provides a bone filling bag which has better affinity with human body and no immunological rejection reaction for clinic, has no toxic or harmful effect on human body and promotes recovery of patients.
The technical scheme of the invention will be further described with reference to examples.
Example 1
The embodiment 1 provides a bone filling pouch, which specifically comprises the following steps:
(1) Raw Silk (RS) with warp yarn of 2.2tex/12f and cooked silk (DS) with weft yarn of 2.2tex/12f are adopted. The woven pouch weave structure adopts a plain weave as shown in fig. 1. The drafting mode is smooth. The double layer weft density was set at 1300 picks per 10cm. Reed number was selected to be 150 reed/10 cm. The penetration number per reed is 8. In order to make yarn tension uniform without broken ends during weaving, the beating-up speed was set to 30m/min and the tension was set to 1.69kg, resulting in a woven bag.
(2) Washing the woven bag for 30min by adopting oxalic acid with the mass fraction of 10% in a constant-temperature water bath at 70 ℃, removing rust impurities, cleaning for a plurality of times by using purified water after finishing, and removing chemical solution on the surface of the fabric; and then washing in distilled water for 20min by using an ultrasonic cleaner to deeply clean, so as to remove chemical residues and other impurities and further ensure the cleaning of the surface of the woven bag.
(3) Degumming raw silk in a woven bag by using 0.05% sodium carbonate at 95 ℃ for 20min as one period, and repeatedly rubbing and washing with distilled water at 60 ℃ to remove sericin after each period is completed. After the degumming and cleaning process is finished, distilled water is used for cleaning for a plurality of minutes, and finally, the sample is subjected to heat setting treatment. And sleeving the woven bag on a clean stainless steel tube with the diameter matched with that of the woven bag, drying and heat-setting the woven bag in an oven at 125 ℃ for 45 minutes to obtain the set woven bag.
(4) Preparing zinc doped hydroxyapatite nano particles by a microwave-hydrothermal method: firstly, 50mL of CaCl of 0.2mol/L is prepared 2 And ZnCl 2 The mixed solution, in which the molar ratio of Zn/(Ca+Zn) was 0.08, was designated as Ca+Zn solution, was prepared to prepare 50mL of 0.12mol/L NaH 2 PO 4 ·2H 2 O, noted as solution P; gradually dripping the solution P into the solution Ca+Zn under magnetic stirring, and using NH all the time 3 ·H 2 And (3) keeping the pH value of the mixed solution between 9 and 10, completely and uniformly stirring, pouring the obtained white emulsion suspension into a hydrothermal reactor, placing the hydrothermal reactor into a microwave reactor, keeping the temperature at 180 ℃ for 30min, washing the precipitate after the reaction with deionized water and ethanol in sequence after the reaction is finished, and freeze-drying for 24h to obtain the ZnHA nano particles.
(5) Preparing a woven pouch with a ZnHA nanoparticle coating: dissolving 0.8g of gelatin powder in 50ml of PBS solution, continuously stirring and keeping the temperature of the solution at 60 ℃ all the time, adding synthesized ZnHA nano particles into 1mg/ml of PBS solution after complete dissolution, performing ultrasonic dispersion for 1h, immersing the woven bag into the solution for 2h, taking out the woven bag after completion, repeatedly flushing the woven bag with deionized water, and drying the woven bag in a baking oven at 60 ℃ for overnight to obtain the woven bag with the ZnHA coating.
(6) Preparing a BMP-2 loaded silk fibroin/heparin coating by adopting a composite film forming mode: firstly, preparing 1g/L silk fibroin solution, (the preparation method of the coating solution is that 25g degummed silk fibroin fiber is taken and dissolved in 100mL LiBr solution with the concentration of 9.3M, the solution is sealed by tinfoil paper and then is put into a 60 ℃ oven for dissolution for 4 hours, the solution is taken out and put into a dialysis bag, the dialysis is carried out in an aqueous solvent for 36 hours, and the supernatant is the silk fibroin solution after centrifugation.
Dissolving heparin in a silk fibroin solution to obtain a silk fibroin/heparin solution of 2mg/mL, immersing a woven bag with a ZnHA coating in the mixed solution, fully stirring, taking out, drying at 80 ℃, and shaping to obtain a ZnHA-SF-Hep woven bag; then preparing a BMP-2 solution with the pH of 2 mg/mL8.5, immersing the ZnHA-SF-Hep woven bag into the solution, oscillating for 4 hours at the temperature of 37 ℃ at 50r/min, washing the bag cleanly under deionized water after finishing, and carrying out vacuum drying in a vacuum drying oven at the temperature of 60 ℃ for 30 minutes to obtain the bone filling bag.
Example 2
The embodiment provides a bone filling pouch, which specifically comprises the following steps:
(1) Raw Silk (RS) with the warp yarn of 3.3tex/12f and cooked silk (DS) with the weft yarn of 2.3tex/12f are adopted. The woven capsular bag weave structure employs a 2/2 twill weave, as shown in fig. 2. The drafting mode is smooth. The double layer weft density was set at 1350 picks per 10cm. Reed number was selected to be 145 reed/10 cm. The penetration number per reed is 8. In order to make the yarn tension uniform without breakage during the weaving process, the beating-up speed was set at 35m/min and the tension was set at 1.74kg.
Step (2) and step (3) are the same as step (2) and step (3) in embodiment 1, and are not described again.
(4) Preparing magnesium doped hydroxyapatite nano particles by adopting a sol-gel method, and preparing CaCl of 0.2mol/L by using deionized water 2 、MgCl 2 Mixed solution in which the molar ratio of Mg/(Ca+Mg) was 0.08, and 0.12mol/L of NaH 2 PO 4 ·2H 2 The solution O is kept at pH 2.5 by hydrochloric acid during the process, mechanically stirred for 1h, the reaction solution is heated in a water bath at 75 ℃ for 4h after being uniformly mixed, the solution O is magnetically stirred to obtain sol, and then the sol is dried in an oven at 110 ℃ for 4h. Placing the dried gel into a muffle furnace for two-step calcinationAnd (3) sintering for 2 hours at 650 ℃ and 4 hours at 900 ℃ respectively to finally obtain the MgHA nano-particles.
(5) Preparing a woven bag with a MgHA nanoparticle coating: dissolving 0.8g of gelatin powder in 50ml of PBS solution, continuously stirring and keeping the temperature of the solution at 60 ℃ all the time, adding synthesized MgHA nano particles into 1mg/ml of PBS solution after complete dissolution, performing ultrasonic dispersion for 1h, immersing the woven bag into the solution for 2h, taking out the woven bag after completion, repeatedly washing the woven bag by deionized water, and drying the woven bag in a 60 ℃ oven overnight to obtain the woven bag with the MgHA coating.
(6) This step is the same as step (6) of example 1, and will not be described again.
Example 3
The embodiment provides a bone filling pouch, which specifically comprises the following steps:
(1) Raw Silk (RS) with warp yarn of 2.2tex/12f and cooked silk (DS) with weft yarn of 2.4tex/12f are adopted. The woven capsular bag stitch structure employs a 3/1 twill weave, as shown in fig. 3. The drafting mode is smooth. The double layer weft density was set at 1400 picks per 10cm. Reed number was selected to be 140 reed/10 cm. The penetration number per reed is 8. In order to make the yarn tension uniform without breakage during the weaving process, the beating-up speed was set to 40m/min and the tension was set to 1.79kg.
Step (2) and step (3) are the same as step (2) and step (3) in embodiment 1, and are not described again.
(4) Preparing strontium-doped hydroxyapatite nano particles by adopting a chemical precipitation method: firstly, 50mL of CaCl of 0.2mol/L is prepared 2 And SrCl 2 The mixed solution, wherein the mole ratio of Sr/(Ca+Sr) is 0.08, is marked as Ca+Sr solution, and 50mL of 0.12mol/L NaH is prepared 2 PO 4 ·2H 2 O, noted as solution P; then pouring the solution Ca+Sr into a three-necked flask, adding 1.25ml of ethanolamine, magnetically stirring at the constant temperature of 40 ℃ in a water bath, simultaneously dripping the solution P into a separating funnel, transferring the mixed solution to a beaker after stirring, hermetically preserving, standing and aging for 24 hours, removing the supernatant after completion, carrying out suction filtration with deionized water for 3-5 times until the solution is neutral, carrying out vacuum drying at the temperature of 90 ℃ for 12 hours, grinding, and carrying out 2 hours in a muffle furnace at the temperature of 700 ℃ to obtain SrHA nano-particles.
(5) Preparing a woven pouch with a SrHA nanoparticle coating: dissolving 0.8g of gelatin powder in 50ml of PBS solution, continuously stirring and keeping the temperature of the solution at 60 ℃ all the time, adding the synthesized SrHA nano particles into 1mg/ml of PBS solution after complete dissolution, performing ultrasonic dispersion for 1h, immersing a silk woven bone filling mesh bag into the solution for 2h, taking out the solution after completion, repeatedly washing the solution by deionized water, and drying the solution in a 60 ℃ oven overnight to obtain the woven bag with the SrHA nano particle coating.
(6) This step is the same as step (6) of example 1, and will not be described again.
Comparative example 1
This comparative example provides a bone filling pouch, which differs from example 1 in that steps (4) - (6) are not present, and the remaining steps are the same as example 1, and are not repeated here. The shaped woven bag obtained in the step (3) is the bone filling bag provided by the comparative example.
Comparative example 2
The comparative example provides a bone filling pouch, wherein polyester monofilaments are adopted for warp and weft, the fineness of the warp is 50D, and the fineness of the weft is 50D. The tubular fabric base weave structure adopts plain weave. The drafting mode is smooth. The double layer weft density can be set at 1300 picks per 10cm. The reed number can be 150 reed/10 cm. The penetration number per reed is 8. In order to make the yarn tension uniform without breakage during the weaving process, the beating-up speed may be set to 40m/min and the set tension may be set to 1.77kg.
Experimental example
The mechanical properties of the bone filling sachets prepared in examples 1-3 and comparative examples 1-2 were measured as follows: according to ISO7198:2016 test method, using a material tester (INSTRON-3365), the specimens were stretched at a constant speed of 50mm/min to break, each sample repeated 5 times, resulting in a tensile strength of the bone capsule filled mesh bag.
Table 1 table of bone filling pouch performance data
| Radial fracture Strength (MPa) | Longitudinal fracture Strength (MPa) | |
| Example 1 | 8.07 | 109.37 |
| Example 2 | 9.22 | 112.14 |
| Example 3 | 7.82 | 105.27 |
| Comparative example 1 | 8.53 | 110.89 |
| Comparative example 2 | 7.79 | 101.40 |
As can be seen from Table 1, the radial fracture strength and the longitudinal fracture strength of the bone-filled pocket prepared by using silk in the invention can reach or even be slightly better than those of the bone-filled pocket prepared by using terylene monofilament as a raw material compared with the commercially available terylene single-layer bone-filled pocket.
Finally, it should be noted that: the above embodiments are only for illustrating the technical solution of the present invention, and not for limiting the same; although the invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some or all of the technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit of the invention.
Claims (29)
1. The bone filling bag is characterized by being mainly obtained by alternately weaving silk warps and wefts; the surface of the bone filling bag is provided with a coating;
the coating comprises a first coating and a second coating which are arranged in a stacked manner;
the first coating is located between the bone-filling pouch surface and the second coating;
the first coating is a metal doped hydroxyapatite coating, wherein the metal comprises at least one of zinc, magnesium and strontium, and the hydroxyapatite is nano hydroxyapatite;
the second coating is a BMP-2 loaded silk fibroin/heparin coating.
2. A method of preparing a bone-filling pouch according to claim 1, wherein a woven pouch is obtained by alternate weaving of raw silk as warp yarn and cooked silk as weft yarn, and a coating is formed on the woven pouch to obtain the bone-filling pouch.
3. The method of making according to claim 2, wherein forming the coating on the woven pouch comprises the steps of:
step A: the woven bag is subjected to first soaking and first drying in a hydroxyapatite dispersion liquid doped with metal to obtain a woven bag with a first coating;
and (B) step (B): and C, soaking the woven bag with the first coating obtained in the step A in a silk fibroin/heparin solution for the second time, drying the woven bag for the second time, and vibrating the woven bag in a BMP-2 solution for the third time to obtain the bone filling bag.
4. The method according to claim 2, wherein the fineness of the warp yarn comprises 2.2tex/12f or 3.3tex/12f.
5. The method according to claim 2, characterized in that the fineness of the weft yarn comprises 2.2tex/12f, 2.3tex/12f or 2.4tex/12f.
6. The method of making according to claim 2, wherein the weave of the woven pocket comprises a plain weave, a 2/2 twill weave, or a 3/1 twill weave.
7. The method of making according to claim 2, wherein the method of drafting the woven bag during weaving comprises forward-threading.
8. The method of making according to claim 2, wherein the double layer weft density of the woven pocket comprises 1300 roots/10 cm, 1350 roots/10 cm or 1400 roots/10 cm.
9. The method of claim 2, wherein the reed number of the woven pocket during weaving comprises 150 reed/10 cm, 145 reed/10 cm or 140 reed/10 cm.
10. The method of claim 2, wherein the woven bag is woven at a beat-up rate of 30m/min to 40m/min during weaving.
11. The method of claim 2, wherein the warp tension of the woven pocket during the weaving process is 1.69kg to 1.79kg.
12. A method of preparing according to claim 3, wherein the dispersion medium of the metal-incorporated hydroxyapatite dispersion comprises a PBS solution.
13. The method of claim 12, wherein the concentration of the PBS solution is 0.5mg/mL-1.5mg/mL.
14. A method of preparation according to claim 3 wherein the first soaking time is 1.5h to 3.5h.
15. A method of manufacture according to claim 3, wherein the first drying temperature is 50 ℃ to 70 ℃.
16. A method of preparation according to claim 3, wherein the first drying time is 8h to 20h.
17. A method of preparation according to claim 3, wherein the second drying temperature is from 75 ℃ to 85 ℃.
18. A method of preparing as claimed in claim 3, wherein the frequency of the oscillation is 45r/min to 55r/min.
19. A method of preparation according to claim 3 wherein the temperature of the oscillation is between 35 ℃ and 39 ℃.
20. A method of preparation according to claim 3 wherein the shaking time is 3.5h to 4.5h.
21. A production method according to claim 3, wherein the third drying is performed in a vacuum drying oven.
22. A method of preparation according to claim 3, wherein the third drying temperature is 50 ℃ to 70 ℃.
23. A method of manufacture according to claim 3, wherein the third drying time is 20-40min.
24. The method of claim 3, wherein the concentration of the silk fibroin/heparin solution is 1.5mg/mL to 2.5mg/mL.
25. The method of claim 3, wherein the BMP-2 solution has a concentration of 1.5mg/mL-2.5mg/mL.
26. The method of claim 3, wherein the BMP-2 solution has a pH of 8-9.
27. The method of claim 3, further comprising a step of degumming the woven pouch after step a and before step B.
28. The method of preparation according to claim 27, wherein the degumming is carried out in a sodium carbonate solution having a concentration of 0.05wt.% to 0.10wt.%.
29. Use of a bone-filling pouch according to claim 1 or prepared by the method of any one of claims 2-28 for loading bone cement.
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