CN106618706A - All-built-in expandable biocoating spine anterior internal fixation system - Google Patents

All-built-in expandable biocoating spine anterior internal fixation system Download PDF

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Publication number
CN106618706A
CN106618706A CN201710118969.2A CN201710118969A CN106618706A CN 106618706 A CN106618706 A CN 106618706A CN 201710118969 A CN201710118969 A CN 201710118969A CN 106618706 A CN106618706 A CN 106618706A
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China
Prior art keywords
blind rivet
fixation system
internal fixation
plug screw
biological coating
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Granted
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CN201710118969.2A
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CN106618706B (en
Inventor
周初松
黄学良
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Southern Medical University Zhujiang Hospital
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Southern Medical University Zhujiang Hospital
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    • 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
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7032—Screws or hooks with U-shaped head or back through which longitudinal rods pass
    • 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
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002—Longitudinal elements, e.g. rods
    • 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
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7074—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08—Materials for coatings
    • A61L31/082—Inorganic materials
    • A61L31/084—Carbon; Graphite
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08—Materials for coatings
    • A61L31/082—Inorganic materials
    • A61L31/086—Phosphorus-containing materials, e.g. apatite
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • 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
    • A61B2017/564—Methods for bone or joint treatment
    • 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
    • A61L2400/18—Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
    • 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
    • A61L2420/00—Materials or methods for coatings medical devices
    • A61L2420/02—Methods for coating medical devices
    • 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
    • A61L2420/00—Materials or methods for coatings medical devices
    • A61L2420/06—Coatings containing a mixture of two or more compounds
    • 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
    • A61L2420/00—Materials or methods for coatings medical devices
    • A61L2420/08—Coatings comprising two or more layers

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Neurology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Epidemiology (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Prostheses (AREA)

Abstract

The invention provides an all built-in expandable biocoating spine anterior internal fixation system, relating to the technical field of medical devices. The all-built-in expandable biocoating spine anterior internal fixation system provided by the invention comprises a fastening nail, a nail core, a connecting rod and a plug screw, and a nano-hydroxyapatite-graphene coating and a nano-hydroxyapatite coating which are cooperated with each other coat the surfaces of the fastening nail, the nail core, the connecting rod and the plug screw, so that tissue compatibility of the fixation system is effectively promoted.

Description

Complete built-in inflatable type biological coating anterior spinal internal fixation system
Technical field
The present invention relates to technical field of medical instruments, more particularly, to a kind of complete built-in inflatable type biological coating backbone Anterior fixation system.
Background technology
Human skeleton is the key for supporting human body, and by the tissue such as joint, muscle, ligament an entirety is connected and composed, With several functions such as support, protection, motion, metabolism and hematopoiesis, the disappearance of bone will cause people greatly life or even life Deposit obstacle.
Bone for human normal life maintenance have important effect, but in the life of people, often due to The reason for disease or contingency, the damage to bone is caused, now, it is necessary to the intervention of surgical operation, using substituting Or complementary medicine equipment, the bone auxiliary to there is damage is fixed, or even is replaced to damaging bone with manual implement, At present, the method for this surgical operation, very common, but the artificial material for using at present mostly is metal, is placed In human body, it is most likely that have the appearance of repulsive interaction, it is unfavorable for the treatment of disease.At present, existing certain methods are adopted Add the method for coating on metal medical appliance to improve histocompatbility, but it is more common mostly be single coating, and still in a organized way The shortcomings of poor compatibility, bad effect.Accordingly, it is desirable to provide one kind can effectively facilitate medical device materials being adapted with human body Coating, to accelerate treatment speed, improve therapeutic effect.
Additionally, in whole skeletal system, the backbone of human body serves vital effect, it is as " pillar " Sample, supports whole human body, if without backbone, the mankind would be impossible to walking of standing.But it is same, there are many patient's needs every year The surgical operation in terms of backbone is carried out, especially the operation in terms of backbone fixation.At present, it is relatively common to fix for backbone Device is nail-stick system and pegboard systems, but remaining cannot meet patient demand, the problems such as histocompatbility difference.
Therefore, the good spinal fixation system of histocompatbility is developed, it is significant.
The content of the invention
It is an object of the invention to provide a kind of complete built-in inflatable type biological coating anterior spinal internal fixation system, with Alleviate the technical problem of medical spinal fixation system histocompatbility difference in prior art.
The invention provides a kind of complete built-in inflatable type biological coating anterior spinal internal fixation system, described complete built-in The inflatable type biological coating anterior spinal internal fixation system of formula includes fixed nail, blind rivet, pitman and plug screw；
The fixed nail is hollow cylindrical-shaped structure, including bulge, connecting portion and afterbody；The bulge uniformly divides Into several expanding petals, the expanding petal inner side is provided with projection to open form, and the blind rivet is inserted into the fixed nail inside, when described Behind the blind rivet insertion fixed nail inside, the blind rivet struts the expanding petal by the projection；The connecting portion has company Socket part internal thread, and for inserting the through hole of the pitman, the afterbody has the operation for being adapted to operation apparatus Hole；The bulge and the connecting portion are externally provided with fixed nail external screw thread；
The blind rivet is rod-like structure, and one end of the blind rivet is taper, and the other end of the blind rivet has and the company The blind rivet external screw thread that socket part internal thread matches, there is the blind rivet the externally threaded one end of blind rivet to have is used to be fitted with operation apparatus The blind rivet groove matched somebody with somebody；
The pitman is bar-shaped, for two adjacent described fixed nails of connection；
The plug screw is inserted into the fixed nail inside, and the plug screw outside has and the connecting portion internal thread phase The plug screw external screw thread matched somebody with somebody, one end of the plug screw has the plug screw groove for being adapted to operation apparatus；
The surface of the fixation nail, blind rivet, pitman and plug screw is coated with biological coating, and the biological coating includes base Layer, and the top layer on the basic unit；The basic unit is nanometer hydroxyapatite-graphite ene coatings；The top layer is nanometer Hydroxyapatite coating layer.
Further, the thickness of the basic unit is 50-100 μm；The thickness on the top layer is 20-50 μm.
Further, the thickness of the basic unit is 80 μm；The thickness on the top layer is 30 μm.
Further, the mass ratio of nanometer hydroxyapatite and Graphene is 100 in the basic unit:0.5～2, preferably 100:1.2。
Further, the raw material specification of the nanometer hydroxyapatite is 40 micron orders.
Further, the number of the expanding petal is four, six or eight, preferably six.
Further, the expanding petal is provided with pore.
Further, the blind rivet groove and plug screw groove are hexagon.
Further, the spraying method of the biological coating is comprised the following steps：
Step (a), pre- protection：Pre- protection, sandblasting are carried out to the fixation nail, blind rivet, pitman and plug screw, at cleaning Reason；
Step (b), the spraying of basic unit：The nanometer hydroxyapatite and the Graphene are carried out into ultrasonic disperse, is obtained Nanometer hydroxyapatite-Graphene mixture, by the nanometer hydroxyapatite-Graphene mixture the fixation is sprayed to The surface of nail, blind rivet, pitman and plug screw, forms the basic unit；
Step (c), the spraying on top layer：The nanometer hydroxyapatite is sprayed into the surface of the basic unit (1), institute is formed State top layer；
The technological parameter of the spraying is：520～530A of spraying current, 60～70V of spray voltage, spray distance 100～ 120mm, 30～40 DEG C of organism temperature.
Further, the technological parameter of the spraying is：Spraying current 525A, spray voltage 64V, spray distance 110mm, 35 DEG C of organism temperature.
The complete built-in inflatable type biological coating anterior spinal internal fixation system that the present invention is provided includes fixed nail, nail Core, pitman and plug screw, and the surface of fixed nail, blind rivet, pitman and plug screw is coated with the nano-hydroxy for cooperating Apatite-graphite ene coatings and nano hydroxyapatite coating, have been effectively promoted the histocompatbility of fixed system.
Description of the drawings
In order to be illustrated more clearly that the specific embodiment of the invention or technical scheme of the prior art, below will be to concrete The accompanying drawing to be used needed for embodiment or description of the prior art is briefly described, it should be apparent that, in describing below Accompanying drawing is some embodiments of the present invention, for those of ordinary skill in the art, before creative work is not paid Put, can be with according to these other accompanying drawings of accompanying drawings acquisition.
Fig. 1 is the biological coating schematic diagram that the embodiment of the present invention 1 is provided；
Fig. 2 is the fixed nail schematic diagram that the embodiment of the present invention 3 is provided；
Fig. 3 is the sectional view of the fixed nail that the embodiment of the present invention 3 is provided；
Fig. 4 is the blind rivet schematic diagram that the embodiment of the present invention 3 is provided；
Fig. 5 is the plug screw schematic diagram that the embodiment of the present invention 3 is provided；
Fig. 6 is that the complete built-in inflatable type biological coating anterior spinal internal fixation system that the embodiment of the present invention 3 is provided is whole Body schematic diagram；
Fig. 7 is the spraying coating process schematic flow sheet of the embodiment of the present invention 3；
Fig. 8 is the animal experimental data result figure of biological coating；
Fig. 9 is the animal experimental data result figure of biological coating.
Icon：1- basic units；2- top layers；3- matrixes；4- fixes nail；41- bulges；411- expanding petals；4111- pores； 412- is raised；42- connecting portions；421- connecting portion internal threads；422- through holes；43- afterbodys；431- handle holes；44- fixes the outer spiral shell of nail Line；5- blind rivets；51- blind rivet external screw threads；52- blind rivet grooves；6- pitmans；7- plug screws；71- plug screw external screw threads；72- plug screws are recessed Groove.
Specific embodiment
Technical scheme is clearly and completely described below in conjunction with accompanying drawing, it is clear that described enforcement Example is a part of embodiment of the invention, rather than the embodiment of whole.Based on the embodiment in the present invention, ordinary skill The every other embodiment that personnel are obtained under the premise of creative work is not made, belongs to the scope of protection of the invention.
In describing the invention, it should be noted that term " " center ", " on ", D score, "left", "right", " vertical ", The orientation or position relationship of the instruction such as " level ", " interior ", " outward " be based on orientation shown in the drawings or position relationship, merely to Be easy to description the present invention and simplify description, rather than indicate or imply indication device or element must have specific orientation, With specific azimuth configuration and operation, therefore it is not considered as limiting the invention.Additionally, term " first ", " second ", " the 3rd " is only used for describing purpose, and it is not intended that indicating or implying relative importance.
In describing the invention, it should be noted that unless otherwise clearly defined and limited, term " installation ", " phase Company ", " connection " should be interpreted broadly, for example, it may be being fixedly connected, or being detachably connected, or be integrally connected；Can Being to be mechanically connected, or electrically connect；Can be joined directly together, it is also possible to be indirectly connected to by intermediary, Ke Yishi The connection of two element internals.For the ordinary skill in the art, with concrete condition above-mentioned term can be understood at this Concrete meaning in invention.
The invention provides a kind of complete built-in inflatable type biological coating anterior spinal internal fixation system, it is complete it is built-in can Intumescent biological coating anterior spinal internal fixation system includes fixed nail 4, blind rivet 5, pitman 6 and plug screw 7, and in fixed nail 4th, the surface of blind rivet 5, pitman 6 and plug screw 7 is coated with biological coating.
Wherein, biological coating includes the top layer 2 on basic unit 1, and basic unit 1；Wherein, basic unit 1 is nano-hydroxy-apatite Stone-graphite ene coatings, top layer 2 is nano hydroxyapatite coating.
The thickness of basic unit 1 is 50-100 μm, for example, can be 50 μm, 60 μm, 70 μm, 80 μm, 90 μm or 100 μm, excellent Select 60-90 μm, most preferably 80 μm；The thickness on top layer 2 is 20-50 μm, for example, can be 20 μm, 30 μm, 40 μm or 50 μm, excellent Select 20-40 μm, most preferably 30 μm.
The degree of crystallinity of basic unit 1 is 93%-95%, for example, can be 93%, 93.5%, 94%, 94.5% or 95%, excellent Select 94%；The degree of crystallinity on top layer 2 is 70%-80%, for example, can be 70%, 71%, 72%, 73%, 74%, 75%, 76%, 76%, 78%, 79% or 80%, preferably 75%.
In the nanometer hydroxyapatite of basic unit 1-graphite ene coatings, the mass ratio of nanometer hydroxyapatite and Graphene is 100:0.5～2, for example can be 100:0.5、100:0.6、100:0.7、100:0.8、100:0.9、100:1、100:1.1、 100:1.2、100:1.3、100:1.4、100:1.5、100:1.6、100:1.7、100:1.8、100:1.9 or 100:2, preferably 100:1～1.5, most preferably 100:1.2.
In addition, the spraying method of biological coating is comprised the following steps：
Step (a), pre- protection：Pre- protection, sandblasting are carried out to fixed nail 4, blind rivet 5, pitman 6 and plug screw 7, at cleaning Reason；
Step (b), the spraying of basic unit 1：Nanometer hydroxyapatite and Graphene are carried out into ultrasonic disperse, nano-hydroxy is obtained Apatite-Graphene mixture, by nanometer hydroxyapatite-Graphene mixture fixed nail 4, blind rivet 5, pitman 6 are sprayed to And the surface of plug screw 7, form basic unit 1；
Step (c), the spraying on top layer 2：Nanometer hydroxyapatite sprays to the surface of basic unit 1, forms top layer 2；
The technological parameter of spraying is：520～530A of spraying current, 60～70V of spray voltage, spray distance 100～ 120mm, 30～40 DEG C of organism temperature.The technological parameter of preferred spraying is：Spraying current 525A, spray voltage 64V, spray away from From 110mm, 35 DEG C of organism temperature.
Wherein, the specification of nanometer hydroxyapatite raw material is 40 micron orders.
In addition, in the complete built-in inflatable type biological coating anterior spinal internal fixation system that the present invention is provided, connection A diameter of 5～7cm of rod 6, for example can for 5cm, 5.2cm, 5.4cm, 5.6cm, 5.8cm, 6cm, 6.2cm, 6.4cm, 6.6cm, 7.8cm or 7cm.The externally threaded pitch of fixed nail is 2～3mm, for example can for 2mm, 2.1mm, 2.2mm, 2.3mm, 2.4mm, 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm or 3mm.
In order to contribute to it is clearer understand present disclosure, the present invention is carried out in detail in conjunction with specific embodiment Introduction.
The biological coating of embodiment 1
Fig. 1 illustrates the schematic diagram of biological coating, and wherein matrix 3 represents the complete built-in inflatable type biology of the present invention Fixed nail 4, blind rivet 5, pitman 6 and plug screw 7 in coating anterior spinal internal fixation system.The direct spraying of basic unit 1 is in matrix 3 On, top layer 2 is sprayed on basic unit 1.Basic unit 1 be nanometer hydroxyapatite-graphite ene coatings, wherein nanometer hydroxyapatite and The mass ratio of Graphene is 100:1.2；Top layer 2 is nano hydroxyapatite coating.
The biology of the complete built-in inflatable type biological coating anterior spinal internal fixation system of the invention that the present invention is provided The both effects with promotion organization compatibility of the basic unit 1 of coating, serve the effect of increase intensity again, and top layer 2 is further improved The histocompatbility of coating.Biological coating due to coating the present embodiment offer on the medical instrument so that medicine equipment After implantation human body, more preferable histocompatbility can be embodied.
The preparation method of the biological coating of embodiment 2
Present embodiments provide biological coating in complete built-in inflatable type biological coating anterior spinal internal fixation system Spraying method, comprises the following steps：
Step (a), pre- protection：Pre- protection, sandblasting are carried out to fixed nail 4, blind rivet 5, pitman 6 and plug screw 7, at cleaning Reason；
Step (b), the spraying of basic unit 1：Nanometer hydroxyapatite and Graphene are carried out into ultrasonic disperse, nano-hydroxy is obtained Apatite-Graphene mixture, by nanometer hydroxyapatite-Graphene mixture fixed nail 4, blind rivet 5, pitman 6 are sprayed to And the surface of plug screw 7, form basic unit 1；
Step (c), the spraying on top layer 2：Nanometer hydroxyapatite sprays to the surface of basic unit 1, forms top layer 2.
The technological parameter of spraying is：Spraying current 525A, spray voltage 64V, spray distance 110mm, 35 DEG C of organism temperature.
The complete built-in inflatable type biological coating anterior spinal internal fixation system of embodiment 3
Present embodiments provide a kind of complete built-in inflatable type biological coating anterior spinal internal fixation system, including fixation Nail 4, blind rivet 5, pitman 6 and plug screw 7, as shown in Fig. 2,3,4,5 and 6.
Fig. 2 is 4 schematic diagrames of fixed nail that the embodiment of the present invention 3 is provided, and Fig. 3 is the fixed nail 4 that the embodiment of the present invention 3 is provided Sectional view, wherein, fixed nail 4 is hollow cylindrical-shaped structure, including bulge 41, connecting portion 42 and afterbody 43；Bulge 41 have uniformly been formed separately six expanding petals 411, and the inner side of each expanding petal 411 is provided with raised 412, and blind rivet 5 can be from afterbody At 43, it is inserted into inside fixed nail 4, after blind rivet 5 is inserted into 4 inside of fixed nail, blind rivet 5 can strut swollen by raised 412 Swollen lobe 411 so that expanding petal 411 opens to surrounding；On expanding petal 411, pore 4111 is additionally provided with, can be added in pore 4111 Promote medicine of bone tissue healing etc., or the time for adding broken bone to accelerate to heal；Connecting portion 42 has connecting portion internal thread 421, and for inserting the through hole 422 of pitman 6, through hole 422 is symmetrical to be distributed on the periphery of connecting portion 42, in this enforcement In example, rearwardly 43 extension of through hole 422 defines " U " type groove；Afterbody 43 has the operation for being adapted to operation apparatus Hole 431, to facilitate the clamping of operation apparatus；Bulge 41 and connecting portion 42 are externally provided with fixed nail external screw thread 44.
Fig. 4 is the schematic diagram of blind rivet 5 that the embodiment of the present invention 3 is provided, and blind rivet 5 is rod-like structure, and one end of blind rivet 5 is cone Shape, the other end of blind rivet 5 has the blind rivet external screw thread 51 matched with the fixed nail connecting portion internal thread 421 of 4 connecting portion 42, blind rivet 5 there is one end of blind rivet external screw thread 51 to have the blind rivet groove 52 for being adapted to operation apparatus, and in the present embodiment, blind rivet is recessed Groove 52 is hexagon, can be used with hexagonal operation apparatus collocation, for the implantation of blind rivet 5.
Pitman 6 is bar-shaped, for two adjacent fixed nails 4 of connection.A diameter of 5～7cm of pitman 6, for example may be used Think 5cm, 5.5cm, 6.0cm, 6.5cm or 7cm.
Fig. 5 is the schematic diagram of plug screw 7 that the embodiment of the present invention 3 is provided, and plug screw 7 is inserted into inside fixed nail 4, outside plug screw 7 Portion has the plug screw external screw thread 71 matched with the fixed nail connecting portion internal thread 421 of 4 connecting portion 42, and one end of plug screw 7 has to be used In the plug screw groove 72 being adapted to operation apparatus, in the present embodiment, plug screw groove 72 is hexagon, can be with hexagonal behaviour Make apparatus collocation to use, for the implantation of plug screw 7.
In the present embodiment, the surface spraying of fixed nail 4, blind rivet 5, pitman 6 and plug screw 7 has what embodiment 1 was provided Biological coating, and sprayed according to the method provided in embodiment 2.The technological process of spraying, as shown in Figure 7.
The present embodiment provide complete built-in inflatable type biological coating anterior spinal internal fixation system in use, First according to the concrete condition of patient, it is determined that the concrete model of the required fixed system for using, with 4 length of fixed nail as 28mm, As a example by a diameter of 8mm.
First, vertebra to be fixed is come out, respectively implantation is fixed in two vertebras up and down for need bearing Nail 4, fixed nail 4 operates apparatus to carry out implant procedure by the fixed nail 4 of handle hole 431 pairs positioned at afterbody 43 in implantation, After the fixed implantation of nail 4, blind rivet 5 is inserted into blind rivet 5 from the afterbody 43 of fixed nail 4, implant procedure available action apparatus passes through Hexagonal blind rivet groove 52 is implemented, when blind rivet 5 enters into connecting portion 42, by the He of connecting portion internal thread 421 for cooperating Blind rivet external screw thread 51 is screwed, and blind rivet 5 is further inserted into bulge 41, and blind rivet 5 is inserted into after bulge 41, blind rivet 5 Shape body is contacted with raised 412, by the effect for extruding, expanding petal 411 is supported, and serves the effect of expansion, can Preferably play fixed effect.Treating up and down at plant, after fixed nail 4 is implanted into respectively, the priority of same pitman 6 is being inserted into two On the through hole 422 of individual fixed nail 4, two fixed nails 4 are made to connect together by pitman 6.It should be noted that treating up and down When being implanted into fixed nail 4 at implantation, need to ensure two through holes 422 for fixing nail 4 in place, to ensure the energy of pitman 6 Enough smoothly insertions.
After insertion pitman 6, plug screw 7 is inserted into inside fixed nail 4 from afterbody 43, and the connection by cooperating Portion's internal thread 421 and blind rivet external screw thread 51 are screwed, and serve the effect for being fixedly connected rod 6, equally, implant procedure available action device Tool is implemented by hexagonal plug screw groove 72.Two fixed nails 4 and a pitman 6, three, can by cooperating Play stable fixation.Finally the complete built-in inflatable type biological coating anterior spinal internal fixation system after assembling is whole Body schematic diagram is as shown in Figure 6.
In order to more fully illustrate present disclosure, now it is described in detail as follows by specific effect example.
The poison experiment of the cell in vitro of effect example 1
First, experiment material
Experimental cell：L cell.
Leaching liquor：The method with reference to specified in National Standard of the People's Republic of China GB/T 16886.12-2005, prepares Leaching liquor, wherein extraction medium is the DMEM in high glucose nutrient solution containing 10% NBCS, extraction ratio is 0.2g/mL, is extracted Condition is 37 ± 1 DEG C of 72 ± 2h of extraction.According to the difference of extraction material, three experimental groups are divided into, wherein, with according to embodiment It is extraction material that method in 2 coats the titanium alloy piece of biological coating in embodiment 1, is experimental group 1；Directly with titanium alloy Piece is extraction material, is experimental group 2；It is negative control group with high density polyethylene (HDPE) to extract material；With dimethyl sulfoxide (DMSO) (volume fraction 5%) is extraction material, is positive controls.
MTT kits：Enough from green skies bio tech ltd.
2nd, test method
With reference to the method that National Standard of the People's Republic of China GB/T 14233.2-2005 specify, fibroblast is existed 37 DEG C, 5%CO2Under conditions of cultivated, take the good l cell of growth conditions and be configured to density for 1 × 104/ The cell suspension of mL, and being inoculated in 96 orifice plates in (100 μ L/ holes), in 37 DEG C, 5%CO2Under the conditions of continue cultivate 24h after, discard Original fluid.Blank control group adds cell culture fluid, negative control group to add negative control group leaching liquor, positive controls to add Enter positive controls leaching liquor, experimental group 1 either 2 adds the leaching liquor of experimental group 1 or 2, is 100 μ L/ holes, is placed in 37 DEG C, 5%CO2Under the conditions of continue cultivate 72h.After culture 72h, according to the method in MTT kit specifications, the extinction per hole is determined Degree, and relative appreciation rate is calculated, wherein relative appreciation rate (RGR) is：
RGR=(A/A0) × 100%
Wherein, A is experimental group (negative control group, positive controls) absorbance；A0For blank control group absorbance.
The relative appreciation rate of each group is calculated, table 1 is listed in.In addition, in GB/T 14233.2-2005 regulations, cytotoxicity Reaction classification is as shown in table 2 with the relation of relative appreciation rate.
Table 1
With respect to appreciation rate (%) Cell-cytotoxic reaction rank
Experimental group 1 95.2 1
Experimental group 2 91.9 1
Negative control group 100 0
Positive controls 7.9 4
The cell-cytotoxic reaction of table 2 is classified
Rank With respect to appreciation rate (%)
0 More than or equal to 100
1 80～99
2 50～79
3 30～49
4 0～29
As shown in table 1, the relative appreciation rate of experimental group 1 has reached 95.2%, and cell-cytotoxic reaction rank is 1 grade, experiment Although group 2 is all 1 grade, relative appreciation rate is 91.9%, and this shows to spray the biology that embodiment 1 is provided in titanium alloy surface After coating, for the more simple titanium alloy of its cytotoxicity, decrease.
The implantation experiment of the animal of effect example 2
Animal used as test：
In the biological coating that the surface of titanium alloy provides according to the method spraying embodiment 1 in embodiment 2, and according to routine Surgical method, the titanium alloy piece for being coated with biological coating is implanted to the back of rat.
Control group 1 and control group 2 are set in addition, and the titanium alloy piece surface of wherein control group 1 is not coated with coating, compares Group 2 is not implanted into titanium alloy piece.
0h after implantation, 12h, 24h, 48h, 72h take rat blood, using the method for quantitative fluorescent PCR, to it The expression of middle IL-6 and TNF-a is analyzed, and the data drawing data figure for obtaining is as shown in Figure 8 and Figure 9.
The ordinate of Fig. 8 represents respectively the experimental data and the IL-6 expressions of control group 2 of experimental group or control group 1 Ratio, abscissa represents respectively the different sample times of experimental group and control group 1 in Fig. 8.As seen from Figure 8, it is outer in implantation After implant, the IL-6 expressions of 1 group of rat of experimental group and control increase, and show that rat occurs after implantation explant Inflammatory reaction, and the expression of IL-6 has significantly reduction compared with control group 1 in experimental group, this also show the table of titanium alloy piece After the biological coating that face spraying embodiment 1 is provided, the impact that body is produced can be substantially reduced.
The ordinate of Fig. 9 represents respectively the experimental data and the TNF-a expressions of control group 2 of experimental group or control group 1 Ratio, abscissa represents respectively the different sample times of experimental group and control group 1 in Fig. 9.With the experimental data situation of IL-6 Similar, after again showing that the biological coating that the surface spraying embodiment 1 of titanium alloy piece is provided, the impact produced to body can significantly Reduce.
Finally it should be noted that：Various embodiments above only to illustrate technical scheme, rather than a limitation；To the greatest extent Pipe has been described in detail with reference to foregoing embodiments to the present invention, it will be understood by those within the art that：Its according to So the technical scheme described in foregoing embodiments can be modified, either which part or all technical characteristic are entered Row equivalent；And these modifications or replacement, do not make the essence disengaging various embodiments of the present invention technology of appropriate technical solution The scope of scheme.

Claims (10)

1. a kind of complete built-in inflatable type biological coating anterior spinal internal fixation system, it is characterised in that described complete built-in Inflatable type biological coating anterior spinal internal fixation system includes fixed nail (4), blind rivet (5), pitman (6) and plug screw (7)；
The fixed nail (4) is hollow cylindrical-shaped structure, including bulge (41), connecting portion (42) and afterbody (43)；It is described Bulge (41) is uniformly formed separately several expanding petals (411), and expanding petal (411) inner side is provided with raised (412), the nail Core (5) is inserted into fixed nail (4) inside, behind the blind rivet (5) insertion described fixed nail (4) inside, the blind rivet (5) expanding petal (411) is strutted by the projection (412)；The connecting portion (42) with connecting portion internal thread (421), And for inserting the through hole (422) of the pitman (6), the afterbody (43) is with the operation for being adapted to operation apparatus Hole (431)；The bulge (41) and the connecting portion (42) are externally provided with fixed nail external screw thread (44)；
The blind rivet (5) is rod-like structure, and one end of the blind rivet (5) is taper, and the other end of the blind rivet (5) has and institute State the blind rivet external screw thread (51) that connecting portion internal thread (421) matches, the described one end of blind rivet (5) with blind rivet external screw thread (51) With the blind rivet groove (52) for being adapted to operation apparatus；
The pitman (6) is bar-shaped, for two adjacent described fixed nails (4) of connection；
The plug screw (7) is inserted into fixed nail (4) inside, has and spiral shell in the connecting portion outside the plug screw (7) The plug screw external screw thread (71) that line (421) matches, one end of the plug screw (7) has for recessed with the plug screw that operation apparatus is adapted to Groove (72)；
The surface of the fixed nail (4), blind rivet (5), pitman (6) and plug screw (7) is coated with biological coating, the biological painting Layer includes the top layer (2) on basic unit (1), and the basic unit (1)；The basic unit (1) is nanometer hydroxyapatite-Graphene Coating；The top layer (2) is nano hydroxyapatite coating.
2. complete built-in inflatable type biological coating anterior spinal internal fixation system according to claim 1, it is characterised in that The thickness of the basic unit (1) is 50-100 μm；The thickness of the top layer (2) is 20-50 μm.
3. complete built-in inflatable type biological coating anterior spinal internal fixation system according to claim 2, its feature exists In the thickness of the basic unit (1) is 80 μm；The thickness of the top layer (2) is 30 μm.
4. complete built-in inflatable type biological coating anterior spinal internal fixation system according to claim 3, its feature exists In the mass ratio of nanometer hydroxyapatite and Graphene is 100 in the basic unit (1):0.5～2, preferably 100:1.2.
5. complete built-in inflatable type biological coating anterior spinal internal fixation system according to claim 4, its feature exists In the raw material specification of the nanometer hydroxyapatite is 40 micron orders.
6. complete built-in inflatable type biological coating anterior spinal internal fixation system according to claim 5, its feature exists In the number of the expanding petal (411) is four, six or eight, preferably six.
7. complete built-in inflatable type biological coating anterior spinal internal fixation system according to claim 6, its feature exists In the expanding petal (411) is provided with pore (4111).
8. complete built-in inflatable type biological coating anterior spinal internal fixation system according to claim 7, its feature exists In, the blind rivet groove (52) and plug screw groove (72) be hexagon.
9. the complete built-in inflatable type biological coating anterior spinal internal fixation system according to any one of claim 6～8, Characterized in that, the spraying method of the biological coating is comprised the following steps：
Step (a), pre- protection：Pre- protection, spray are carried out to the fixed nail (4), blind rivet (5), pitman (6) and plug screw (7) Sand, cleaning treatment；
Step (b), the spraying of basic unit (1)：The nanometer hydroxyapatite and the Graphene are carried out into ultrasonic disperse, is received Rice hydroxyapatite-Graphene mixture, by the nanometer hydroxyapatite-Graphene mixture the fixed nail is sprayed to (4), the surface of blind rivet (5), pitman (6) and plug screw (7), forms the basic unit (1)；
Step (c), the spraying of top layer (2)：The nanometer hydroxyapatite is sprayed into the surface of the basic unit (1), institute is formed State top layer (2)；
The technological parameter of the spraying is：520～530A of spraying current, 60～70V of spray voltage, spray distance 100～ 120mm, 30～40 DEG C of organism temperature.
10. complete built-in inflatable type biological coating anterior spinal internal fixation system according to claim 9, its feature exists In the technological parameter of the spraying is：Spraying current 525A, spray voltage 64V, spray distance 110mm, 35 DEG C of organism temperature.
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CN102772241A (en) * 2011-05-11 2012-11-14 上海鼎桥生物科技有限公司 Minimally invasive internal fixation fusion system for anterior spinal column
CN102579120A (en) * 2012-02-23 2012-07-18 北京市富乐科技开发有限公司 Full built-in expandable anterior spinal fixation system
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