CN116159187B - Integrated oral cavity repairing set for guiding soft and hard tissue regeneration and repair - Google Patents

Integrated oral cavity repairing set for guiding soft and hard tissue regeneration and repair Download PDF

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Publication number
CN116159187B
CN116159187B CN202211657118.2A CN202211657118A CN116159187B CN 116159187 B CN116159187 B CN 116159187B CN 202211657118 A CN202211657118 A CN 202211657118A CN 116159187 B CN116159187 B CN 116159187B
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gel
soft
bone
nozzle
freeze
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CN116159187A (en
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谢志坚
史洋
谢明君
顾静怡
柯志威
石珏
戎佳炳
邵长鹆
陈卓
张淳
宓锐
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Zhejiang University ZJU
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Zhejiang University ZJU
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C19/00—Dental auxiliary appliances
    • A61C19/06—Implements for therapeutic treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C19/00—Dental auxiliary appliances
    • A61C19/003—Apparatus for curing resins by radiation
    • A61C19/004—Hand-held apparatus, e.g. guns
    • 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
    • A61L27/20—Polysaccharides
    • 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
    • A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/222—Gelatin
    • 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
    • A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/227—Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
    • 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
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
    • 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
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
    • A61L27/3608—Bone, e.g. demineralised bone matrix [DBM], bone powder
    • 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
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3641—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the site of application in the body
    • 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
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3641—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the site of application in the body
    • A61L27/3645—Connective tissue
    • A61L27/365—Bones
    • 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
    • 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
    • A61L27/52—Hydrogels or hydrocolloids
    • 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
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/412—Tissue-regenerating or healing or proliferative agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/412—Tissue-regenerating or healing or proliferative agents
    • A61L2300/414—Growth factors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/06—Flowable or injectable implant compositions
    • 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
    • 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
    • A61L2430/34—Materials or treatment for tissue regeneration for soft tissue reconstruction

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  • Oral & Maxillofacial Surgery (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
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  • Urology & Nephrology (AREA)
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  • Orthopedic Medicine & Surgery (AREA)
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Abstract

The invention discloses an integrated oral cavity repairing set for guiding soft and hard tissue regeneration and repair, and belongs to the technical field of biological medicine materials. The kit comprises bone gel capable of being injected in situ, soft tissue gel capable of being injected in situ, a bone gel nozzle, a soft tissue gel nozzle and a pre-curing annular lamp; wherein, the bone gel capable of being injected in situ is obtained by loading factors with osteogenesis inducing function into the photo-curing hydrogel, freeze-drying the factors to become freeze-dried powder, and then loading the freeze-dried powder into a bone gel injector after irradiation sterilization; the soft tissue gel capable of being injected in situ is obtained by preparing relevant functional hydrogel prepolymer liquid of the keratinized gingival repair layer and the submucosal repair layer respectively, freeze-drying the prepolymer liquid to become freeze-dried powder, and then filling the two freeze-dried powder into a soft tissue gel injector after irradiation sterilization. The invention realizes the synchronous repair of the soft and hard tissue defects of the oral cavity while meeting the requirement of firmly filling any complex defect shape by an in-situ injection mode.

Description

Integrated oral cavity repairing set for guiding soft and hard tissue regeneration and repair
Technical Field
The invention belongs to the technical field of biomedical materials, and particularly relates to an integrated oral cavity repair kit (ALL-IN-ONE Combi-kit) capable of repairing oral cavity soft and hard tissue defects at the same time.
Background
Various reasons often cause the defect of large-area bone tissue of the oromaxillofacial region, the oral cavity function of a patient is greatly influenced, and the defect of the bone tissue of the oral cavity is mostly accompanied with the retraction of soft tissues, so that the aim of regenerating and repairing the soft tissues and the hard tissues is often needed through primary bone increment operation and secondary soft tissue transplantation operation at present. In the bone increment operation, the heterogeneous calf bone is the most commonly used bone grafting material in clinic at present, but the granular structure of the heterogeneous calf bone is easy to scatter to a non-operation area in the operation, and the operation progress is influenced by multiple taking and placing; at the same time, the space occupation caused by the low substitution rate also hinders the regeneration of new bone. In addition, the barrier membrane is often required to be covered to block rapidly growing soft tissues after the bone graft material is implanted in the defect area, the barrier membrane which is most commonly used at present is a heterogeneous collagen membrane, but the barrier membrane lacks binding force with the bone powder material below, the barrier membrane is often shifted due to operation or chewing after operation, the barrier function is lost, bone powder is exposed, and the risk of infection in the operation area is increased. Moreover, soft tissue tension is another technical challenge in closing the wound when the bone augmentation range exceeds the original surgical field contour, and it is often necessary to perform a primary suture with an autologous soft tissue graft, which undoubtedly adds surgical trauma to the patient. Therefore, developing an integrated repair material capable of synchronously treating soft and hard tissue composite defects is a great requirement of the current oral clinic.
Disclosure of Invention
The invention aims to overcome the problems of the prior art that the oral soft and hard tissues are defective and need to be repaired in stages, the retention property of the prior soft and hard tissue repair materials is poor, and the like, and provides an integrated oral repair kit for guiding the regeneration and repair of the soft and hard tissues. The integrated oral cavity repairing set contains the repairing material capable of simultaneously repairing soft and hard tissues, and achieves the aim of synchronously repairing the soft and hard tissues of the oral cavity while meeting the requirement of firmly filling any complex defect form by an in-situ injection mode.
The specific technical scheme adopted by the invention is as follows:
the invention provides an integrated oral cavity repairing set for guiding soft and hard tissue regeneration and repair, which comprises an in-situ injectable bone gel, an in-situ injectable soft tissue gel, a bone gel nozzle, a soft tissue gel nozzle and a pre-curing annular lamp;
the bone gel capable of being injected in situ is obtained by loading factors with osteogenesis induction function into photo-curing hydrogel, freeze-drying the factors to become freeze-dried powder, and filling the freeze-dried powder into a bone gel injector after irradiation sterilization;
the soft tissue gel capable of being injected in situ is obtained by preparing relevant functional hydrogel prepolymer liquid of a keratinized gingival repair layer and a submucosal repair layer respectively, freeze-drying the prepolymer liquid to obtain freeze-dried powder, and then filling the freeze-dried powder and the freeze-dried powder into a soft tissue gel injector after irradiation sterilization;
the bone gel nozzle is used for being arranged at the injection nozzle of the bone gel injector and is sequentially divided into an opaque post-curing nozzle section and a transparent pre-curing nozzle section along the injection direction;
The soft tissue gel nozzle is made of transparent materials and is used for being arranged at the injection nozzle of the soft tissue gel injector;
the pre-curing ring lamp is used for being clamped on the bone gel nozzle or the soft tissue gel nozzle so as to realize the pre-curing of the gel material in the sending-out process.
Preferably, the photocuring hydrogel is a material with photocuring biocompatibility, and comprises one or more of methacryloylated gelatin, methacryloylated silk fibroin and methacryloylated hyaluronic acid.
Preferably, the factor having osteoinductive function comprises one or more of human bone morphogenetic protein, nel-like molecule type I.
Preferably, the injectable bone gel in situ is divided into a plurality of sizes according to different capacities, preferably three sizes of 0.25cc, 0.5cc and 1cc are used.
Preferably, the injectable soft tissue gel is divided into a plurality of sizes according to different capacities, preferably three sizes of 0.1cc,0.2cc and 0.3cc are used.
Preferably, in the relevant functional hydrogel prepolymer liquid of the keratinized gingival repair layer, the gel main material comprises one or more of methacryloylated gelatin, methacryloylated silk fibroin, methacryloylated hyaluronic acid and methacryloylated sodium alginate, and the functional factors loaded in the gel main material comprise one or more of keratinocyte growth factor and transforming growth factor.
Preferably, in the relevant functional hydrogel prepolymer solution of the submucosa repair layer, the gel main material comprises one or more of methacryloylated gelatin, methacryloylated silk fibroin, methacryloylated hyaluronic acid and methacryloylated sodium alginate, and the functional factors carried in the gel main material comprise fibroblast growth factors.
Preferably, the cross section of the emitting end of the bone gel nozzle is circular, and the diameter is preferably 2mm, 4mm or 6mm.
Preferably, the cross section of the emergent end of the soft tissue gel nozzle is elliptical, the major axis is 6mm, and the minor axis is 3mm.
Further, in the short axial length, one side for containing the lyophilized powder of the keratinized gingival repair layer is 1mm, and one side for containing the submucosal repair layer is 2mm.
Compared with the prior art, the invention has the following beneficial effects:
1) The injectable bone gel injector provided by the invention can be adapted to nozzles with two different curing modes, wherein the pre-curing nozzle can be used for unfavorable bone defect areas, so that the microsphere phase is utilized for preliminary contour accumulation molding, then the precise bone contour recovery is carried out through a molding cutter, the post-curing can be used for favorable bone defect areas, the flowing ink is adapted to defect areas which are extremely narrow and can not be accessed by the microsphere phase, and the ideal filling between filling materials and micro gaps of the defect areas is realized. Therefore, the bone gel can meet the personalized bone grafting requirements of all clinical scenes of bone defects from small to large and from easy to difficult, and the bone increment is completed in an optimal way.
2) The soft tissue barrier/repair membrane designed by the invention is pre-cured in a transparent nozzle of a double-pipeline injector through two repair pre-polymerization liquids by a pre-curing annular lamp to form a gel structure which is injected and covered on the surface of bone gel, so that the operability is good; the dental implant has the dual repairing functions of physiologically guiding the gum soft tissue mucous membrane layer and the keratinization layer while the small aperture blocks the tooth fibroblast from growing into the bone defect area.
3) The product breaks through the technical barriers of realizing the dual repair function by the single material at present, fully utilizes the excellent universality of the hydrogel material, is used as a shared main body of the injectable bone gel and the soft tissue barrier/repair film, and is used for curing the upper soft tissue gel and the lower bone gel into a whole through photoinitiation, so that the integrated filling repair and full-period barrier are realized, and great convenience is brought to clinical operation.
4) Based on the oral clinic dental filling concept, the ALL-IN-ONE Combi-Kit integrated dental restoration set product is a composite set integrating hard tissue restoration, soft tissue barrier and regeneration restoration functions, and fills the clinical blank of the existing oral soft and hard tissue integrated regeneration restoration material; the kit comprises bone gel syringes (containing functional gel freeze-dried powder), soft tissue barrier/repair syringes (containing functional gel freeze-dried powder), soft/hard tissue transparent/light-proof nozzles of different types (sizes) and pre-curing annular lamp fittings, wherein a clinical operator can select soft and hard tissue repair syringes of different specifications and corresponding nozzles of different sizes according to the actual defect size of a patient, and a specific curing mode is selected according to different defect forms, so that personalized soft and hard tissue synchronous repair is finally realized.
Drawings
Fig. 1: the invention relates to an integrated oral cavity repairing suit structure schematic diagram;
Fig. 2: the integrated oral cavity repairing suit of the invention treats the schematic diagram of repairing the soft and hard tissue defect after tooth extraction;
The reference numerals in the drawings are: bone gel injector 1, soft tissue gel injector 2, bone gel nozzle 3, soft tissue gel nozzle 4.
Detailed Description
The invention is further illustrated and described below with reference to the drawings and detailed description. The technical features of the embodiments of the invention can be combined correspondingly on the premise of no mutual conflict.
As shown IN fig. 1, the invention provides an integrated oral cavity repairing set for guiding soft and hard tissue regeneration and repair, which comprises the following specific contents:
1) Bone gel may be injected in situ: the factors with osteogenesis inducing function are loaded in the photo-curing hydrogel, the factors are freeze-dried to become freeze-dried powder, and the freeze-dried powder is put into a bone gel injector 1 after irradiation sterilization. In practice, the bone gel syringe 1 should be a sterile syringe, and may be classified into various specifications according to different capacities, for example, three specifications of 0.25cc, 0.5cc and 1cc are used.
In particular, the gel main body material which can be selected from the bone gel for in-situ injection can be a material with good photo-curing biocompatibility, such as methacryloylated gelatin, methacryloylated silk fibroin, methacryloylated hyaluronic acid and the like. The factor may be a growth factor having osteoinductive function, such as human Bone Morphogenetic Proteins (BMPs), nel-like molecule type I (Nell-1), or any active molecule having osteogenic action.
2) Soft tissue gels can be injected in situ: the soft tissue gel is divided into a keratinized gingival repair layer and a submucosal repair layer according to the physiological structure of the oral soft tissue, specifically, relevant functional hydrogel prepolymer liquid of the keratinized gingival repair layer and the submucosal repair layer is prepared respectively, and then the gel is freeze-dried to become freeze-dried powder, and then the two freeze-dried powders are irradiated and sterilized and then are filled into the double-tube soft tissue gel injector 2. In practice, injectable soft tissue gels in situ can be divided into a number of sizes depending on the volume, for example, three sizes of 0.1cc,0.2cc and 0.3cc are used.
Particularly, the gel host material used for the submucosa repair layer of the soft tissue gel can be a material with small pore size and good photo-curing biocompatibility, namely, the material is provided with a small pore size (< 300 um) after swelling so as to prevent the fibroblast from being afraid of entering downwards, such as methacryloylated gelatin, methacryloylated silk protein, methacryloylated hyaluronic acid, methacryloylated sodium alginate and the like. The factor carried by the submucosa repair layer can be any active molecule such as Fibroblast Growth Factor (FGF) that has the effect of promoting proliferation and differentiation of fibroblasts.
Particularly, the gel main body material of the soft tissue gel, which is selected from the group consisting of photo-cured biocompatible materials, such as methacryloylated gelatin, methacryloylated silk fibroin, methacryloylated hyaluronic acid, methacryloylated sodium alginate, and the like. The factor loaded can be Keratinocyte Growth Factor (KGF), transforming Growth Factor (TGF) and other active molecules with keratinocyte growth promoting effect.
3) Bone gel nozzle 3: for mounting at the nozzle of the bone gel injector 1, is divided into an opaque post-curing nozzle section and a transparent pre-curing nozzle section in sequence along the injection direction.
In actual use, the cross section of the emergent end of the bone gel nozzle 3 is preferably circular, and the diameter of the emergent end can be divided into a plurality of specifications of 2mm, 4mm, 6mm and the like so as to meet the effective filling of different bone defect shapes and sizes; meanwhile, each diameter specification can be divided into a pre-curing nozzle section (transparent nozzle) and a post-curing nozzle section (opaque nozzle) so as to meet the requirements of different bone defect plasticity requirements.
4) Soft tissue gel nozzle 4: transparent material for mounting at the nozzle of the soft tissue gel syringe 2.
In actual use, the cross section of the exit end of the soft tissue gel nozzle 4 is preferably elliptical in shape in order to achieve a pre-cured soft tissue repair layer. The major axis of the ellipse may be 6mm and the minor axis may be 3mm; in the short axial length, one side for containing the lyophilized powder of the keratinized gingival repair layer is 1mm, and one side for containing the submucosal repair layer is 2mm.
5) Pre-cure ring lamp: can be clamped on the bone gel nozzle 3 or the soft tissue gel nozzle 4, so that the gel is pre-cured in the extrusion process, and good shaping is realized.
Example 1
The embodiment utilizes the integral dental restoration Kit 'ALL-IN-ONE Combi-Kit' provided by the invention, and can treat soft and hard tissue composite defect restoration caused by tooth extraction, and the specific application steps are as follows:
1) Osteolytic gel:
Unscrewing the sealing cover of the bone gel injector, sucking a certain amount of physiological saline into the injector according to the volume proportion of the freeze-dried powder to re-dissolve the freeze-dried powder, and uniformly mixing to obtain the bone gel capable of being injected in situ.
2) Reconstitution of soft tissue gel:
unscrewing the sealing cover of the soft tissue gel injector, sucking a certain amount of physiological saline into the injector according to the volume proportion of the freeze-dried powder to re-dissolve the freeze-dried powder, and uniformly mixing to obtain the soft tissue gel capable of being injected in situ.
3) Mounting and filling of a bone gel spray head:
Because the root tip of the defect caused by tooth extraction is narrow and is an advantageous defect with bone walls at the periphery, a light-resistant narrow-diameter nozzle (such as 2 mm) and a post-curing scheme are selected, a sealing cover is screwed out, the narrow-diameter light-resistant nozzle is screwed into a bone gel injector, then bone gel is extruded to a bone defect area through the injector, the bone defect area is naturally filled by utilizing the ideal fluidity of ink, and after the shaping instrument is shaped to an ideal bone contour, the bone gel is cured by a dental light curing lamp.
4) Installation of soft tissue gel and pre-cure injection:
And (3) screwing out a sealing cover of the soft tissue gel injector, screwing a transparent soft tissue nozzle into the reconstituted soft tissue injector, installing a pre-curing annular lamp to enable the keratotic gingival repair layer to face upwards, pre-curing the mucosa repair layer downwards for 5 seconds, and uniformly covering the surface of the bone gel, and curing and covering simultaneously to ensure the integrity of the soft tissue repair layer.
5) Soft and hard tissue integrated prosthesis establishment:
After the soft tissue barrier/repair film is covered, the soft tissue barrier/repair film and the bone tissue gel are combined by using a dental light curing lamp for 5 seconds to complete integral filling (shown in figure 2).
Example 2
The embodiment utilizes the integral dental restoration Kit 'ALL-IN-ONE Combi-Kit' provided by the invention, can treat common increment of soft and hard tissues IN the vertical bone increment process, and comprises the following specific using steps:
1) Osteolytic gel:
Unscrewing the sealing cover of the bone gel injector, sucking a certain amount of physiological saline into the injector according to the volume proportion of the freeze-dried powder to re-dissolve the freeze-dried powder, and uniformly mixing to obtain the bone gel capable of being injected in situ.
2) Reconstitution of soft tissue gel:
unscrewing the sealing cover of the soft tissue gel injector, sucking a certain amount of physiological saline into the injector according to the volume proportion of the freeze-dried powder to re-dissolve the freeze-dried powder, and uniformly mixing to obtain the soft tissue gel capable of being injected in situ.
3) Mounting and filling of a bone gel spray head:
because the vertical bone increment is a defect with no bone wall support at the periphery, a transparent wide-diameter nozzle (such as 6 mm) and a pre-curing scheme are selected, the wide-diameter nozzle is screwed into a bone gel injector, then the bone gel is molded in advance in a mode of extruding and curing (pre-curing), then gel is injected into an operation area, and a molding knife is used for molding to obtain an ideal bone profile.
4) Installation of soft tissue gel and pre-cure injection:
And (3) screwing out a sealing cover of the soft tissue gel injector, screwing a transparent soft tissue nozzle into the reconstituted soft tissue injector, installing a pre-curing annular lamp to enable the keratotic gingival repair layer to face upwards, pre-curing the mucosa repair layer downwards for 5 seconds, and uniformly covering the surface of the bone gel, and curing and covering simultaneously to ensure the integrity of the soft tissue repair layer.
5) Soft and hard tissue integrated prosthesis establishment:
After the soft tissue barrier/repair film is covered, finally curing for 5 seconds by using a dental light curing lamp so as to realize the combination of the soft tissue barrier/repair film and bone tissue gel of the same main body and complete the integrated filling.
The above embodiment is only a preferred embodiment of the present invention, but it is not intended to limit the present invention. Various changes and modifications may be made by one of ordinary skill in the pertinent art without departing from the spirit and scope of the present invention. Therefore, all the technical schemes obtained by adopting the equivalent substitution or equivalent transformation are within the protection scope of the invention.

Claims (10)

1. An integrated oral cavity repairing set for guiding soft and hard tissue regeneration and repair is characterized by comprising bone gel capable of being injected in situ, soft tissue gel capable of being injected in situ, a bone gel nozzle (3), a soft tissue gel nozzle (4) and a pre-curing annular lamp;
The bone gel capable of being injected in situ is obtained by loading factors with osteogenesis induction function into photo-cured hydrogel, freeze-drying the factors to become freeze-dried powder, and filling the freeze-dried powder into a bone gel injector (1) after irradiation sterilization;
The soft tissue gel capable of being injected in situ is obtained by preparing relevant functional hydrogel prepolymer liquid of a keratinized gingival repair layer and a submucosal repair layer respectively, freeze-drying the prepolymer liquid to obtain freeze-dried powder, and then filling the two freeze-dried powder into a double-tube soft tissue gel injector (2) after irradiation sterilization;
The bone gel nozzle (3) is used for being arranged at the injection nozzle of the bone gel injector (1) and is sequentially divided into an opaque post-curing nozzle section and a transparent pre-curing nozzle section along the injection direction;
The soft tissue gel nozzle (4) is made of transparent materials and is used for being arranged at the injection nozzle of the soft tissue gel injector (2);
The pre-curing ring lamp is used for being clamped on the bone gel nozzle (3) or the soft tissue gel nozzle (4) so as to realize the pre-curing of the gel material in the extrusion process.
2. The integrated dental restoration kit for guiding soft and hard tissue regeneration restoration according to claim 1, wherein the photocurable hydrogel is a material having photocuring biocompatibility, including one or more of methacryloylated gelatin, methacryloylated silk protein, methacryloylated hyaluronic acid.
3. The integrated dental restoration kit for guiding soft and hard tissue regeneration and restoration according to claim 1, wherein said factor having an osteogenic induction function comprises one or more of human bone morphogenic protein, a Nel-like molecule type i.
4. The integrated dental restoration kit for guiding soft and hard tissue regeneration restoration according to claim 1, wherein said injectable bone gel is divided into a plurality of specifications including 0.25cc, 0.5cc and 1cc according to different capacities.
5. The integrated dental restoration kit for guiding soft and hard tissue regeneration restoration according to claim 1, wherein the injectable soft tissue gel is divided into a plurality of specifications including 0.1cc,0.2cc and 0.3cc according to different capacities.
6. The integrated dental restoration kit for guiding soft and hard tissue regeneration and restoration according to claim 1, wherein in the relevant functional hydrogel prepolymerization solution of the keratinized gingival restoration layer, the gel main material comprises one or more of methacryloylated gelatin, methacryloylated silk fibroin, methacryloylated hyaluronic acid and methacryloylated sodium alginate, and the functional factors carried in the gel main material comprise one or more of keratinocyte growth factor and transforming growth factor.
7. The integrated dental restoration kit for guiding soft and hard tissue regeneration and restoration according to claim 1, wherein in the relevant functional hydrogel prepolymer liquid of the submucosa restoration layer, the gel main material comprises one or more of methacryloylated gelatin, methacryloylated silk fibroin, methacryloylated hyaluronic acid and methacryloylated sodium alginate, and the functional factors carried in the gel main material comprise fibroblast growth factors.
8. The integrated dental restoration kit for guiding soft and hard tissue regeneration restoration according to claim 1, wherein the cross section of the exit end of the bone gel nozzle (3) is circular, and the diameter is one of 2mm, 4mm or 6 mm.
9. The integrated oral repair kit for guiding soft and hard tissue regeneration and repair according to claim 1, wherein the cross section of the exit end of the soft tissue gel nozzle (4) is elliptical, the major axis is 6mm, and the minor axis is 3mm.
10. The integrated oral restoration kit for guiding soft and hard tissue regeneration and restoration according to claim 9, wherein one side of the short axial length for holding the lyophilized powder of the keratinized gingival restoration layer is 1mm and one side for holding the submucosal restoration layer is 2mm.
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US5292253A (en) * 1992-06-22 1994-03-08 Laser Medical Technology, Inc. Method for repairing tooth and bone tissue
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WO2014040026A2 (en) * 2012-09-10 2014-03-13 Wake Forest University Health Sciences Amniotic membrane and its use in wound healing and tissue engineering constructs
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US5292253A (en) * 1992-06-22 1994-03-08 Laser Medical Technology, Inc. Method for repairing tooth and bone tissue
KR20160032638A (en) * 2014-09-16 2016-03-24 서울과학기술대학교 산학협력단 Multi-layered hybrid scaffold with porous, biodegradable and controlled-release for simultaneous regeneration of soft and hard tissues

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