CN110368147A - Invasive lumbar fusion device and preparation method thereof - Google Patents
Invasive lumbar fusion device and preparation method thereof Download PDFInfo
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- CN110368147A CN110368147A CN201910718329.4A CN201910718329A CN110368147A CN 110368147 A CN110368147 A CN 110368147A CN 201910718329 A CN201910718329 A CN 201910718329A CN 110368147 A CN110368147 A CN 110368147A
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- 230000004927 fusion Effects 0.000 title claims abstract description 75
- 238000002360 preparation method Methods 0.000 title claims abstract description 19
- 238000002513 implantation Methods 0.000 claims abstract description 14
- 239000000463 material Substances 0.000 claims description 18
- 238000000034 method Methods 0.000 claims description 17
- 229920002635 polyurethane Polymers 0.000 claims description 14
- 239000004814 polyurethane Substances 0.000 claims description 14
- 239000004372 Polyvinyl alcohol Substances 0.000 claims description 9
- 229920000747 poly(lactic acid) Polymers 0.000 claims description 9
- 239000004626 polylactic acid Substances 0.000 claims description 9
- 229920002451 polyvinyl alcohol Polymers 0.000 claims description 9
- 239000013049 sediment Substances 0.000 claims description 5
- 230000008676 import Effects 0.000 claims description 4
- 230000004048 modification Effects 0.000 claims description 3
- 238000012986 modification Methods 0.000 claims description 3
- 239000002861 polymer material Substances 0.000 abstract description 7
- 238000005267 amalgamation Methods 0.000 abstract description 6
- 206010061246 Intervertebral disc degeneration Diseases 0.000 abstract description 4
- 208000018180 degenerative disc disease Diseases 0.000 abstract description 3
- 208000021600 intervertebral disc degenerative disease Diseases 0.000 abstract description 3
- 125000001153 fluoro group Chemical group F* 0.000 description 5
- 238000002347 injection Methods 0.000 description 5
- 239000007924 injection Substances 0.000 description 5
- 238000004132 cross linking Methods 0.000 description 4
- 239000007943 implant Substances 0.000 description 4
- 238000007493 shaping process Methods 0.000 description 4
- 208000003618 Intervertebral Disc Displacement Diseases 0.000 description 3
- 210000000988 bone and bone Anatomy 0.000 description 3
- 201000010099 disease Diseases 0.000 description 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 3
- 210000001519 tissue Anatomy 0.000 description 3
- 206010050296 Intervertebral disc protrusion Diseases 0.000 description 2
- 230000015572 biosynthetic process Effects 0.000 description 2
- 210000000845 cartilage Anatomy 0.000 description 2
- 230000035479 physiological effects, processes and functions Effects 0.000 description 2
- 239000011148 porous material Substances 0.000 description 2
- 238000007639 printing Methods 0.000 description 2
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- 238000010146 3D printing Methods 0.000 description 1
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- 210000003484 anatomy Anatomy 0.000 description 1
- 230000008859 change Effects 0.000 description 1
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- 230000007159 enucleation Effects 0.000 description 1
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- 238000005468 ion implantation Methods 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 208000015122 neurodegenerative disease Diseases 0.000 description 1
- 201000008482 osteoarthritis Diseases 0.000 description 1
- 238000003672 processing method Methods 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 230000008439 repair process Effects 0.000 description 1
- 238000002271 resection Methods 0.000 description 1
- 210000001032 spinal nerve Anatomy 0.000 description 1
- 230000003068 static effect Effects 0.000 description 1
- TXEYQDLBPFQVAA-UHFFFAOYSA-N tetrafluoromethane Chemical compound FC(F)(F)F TXEYQDLBPFQVAA-UHFFFAOYSA-N 0.000 description 1
- 238000004073 vulcanization Methods 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
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- A—HUMAN NECESSITIES
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
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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
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- A61L27/14—Macromolecular materials
- A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
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- A—HUMAN NECESSITIES
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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
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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
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- A61L27/56—Porous materials, e.g. foams or sponges
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
- A61F2002/30772—Apertures or holes, e.g. of circular cross section
- A61F2002/30784—Plurality of holes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2002/30985—Designing or manufacturing processes using three dimensional printing [3DP]
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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
- A61L2430/38—Materials or treatment for tissue regeneration for reconstruction of the spine, vertebrae or intervertebral discs
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- Orthopedic Medicine & Surgery (AREA)
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Abstract
The present invention provides a kind of Invasive lumbar fusion device and preparation method thereof, Invasive lumbar fusion device includes: the first porous structure layer, and the first porous structure layer has multiple holes；Second porous structure layer, the second porous structure layer have multiple holes；Entity structure layer, one end of entity structure layer are connect with the first porous structure layer, and the other end of entity structure layer is connect with the second porous structure layer；First porous structure layer, the second porous structure layer and entity structure layer are the integrated formed structure made of polymer material, and the elasticity modulus of entity structure layer is less than the elasticity modulus of the first porous structure layer and the elasticity modulus of the second porous structure layer.The Invasive lumbar fusion device has good elastic property, has good amalgamation with skeleton after the implantation, can slow down or avoid the intervertebral disc degeneration of adjacent segment, guarantees late result.
Description
Technical field
The present invention relates to the field of medical instrument technology, in particular to a kind of Invasive lumbar fusion device and preparation method thereof.
Background technique
Interverbebral disc was not only tough and tensile, but also full of elasticity, was compressed when bearing pressure, restores again after removing pressure, has elasticity, can
Concussion of the external force to backbone is buffered, the motion amplitude of backbone can also be increased.However the degenerative disease of interverbebral disc has become at present
The main reason for a kind of common disease and frequently-occurring disease, spinal nerve compressing caused by Intervertebral Source is also clinical neck-shoulder pain, lumbago and leg pain, sternly
The quality of life of patient is affected again.
The existing processing method for interverbebral disc has simple Lumbar intervertebral disc protrusion enucleation, the fusion of intervertebral, artificial intervertebral disk
Displacement technique etc..But simple Lumbar intervertebral disc protrusion resection of nucleus pulposus high recurrence rate, the reduction of intervertebral load cause zygapophysial joint load to increase
Add and easily lead to osteoarthritis, late result is dissatisfied.Although intervertebral reaches Bony union to vertebra by bone grafting or Invasive lumbar fusion device
The short term efficacy of disk source property disease is satisfied, but amalgamation and elastic property are poor, and there are the intervertebral disc degenerations of adjacent segment to add
Speed and fixed-segment it is stiff, late result is also unsatisfactory.
Summary of the invention
The present invention provides a kind of Invasive lumbar fusion devices and preparation method thereof, to solve Invasive lumbar fusion device in the prior art
The problem of amalgamation and elastic property are poor, are not able to satisfy late result.
To solve the above-mentioned problems, according to an aspect of the present invention, the present invention provides a kind of Invasive lumbar fusion device, packets
Include: the first porous structure layer, the first porous structure layer have multiple holes；Second porous structure layer, the second porous structure layer tool
There are multiple holes；Entity structure layer, one end of entity structure layer are connect with the first porous structure layer, the other end of entity structure layer
It is connect with the second porous structure layer；First porous structure layer, the second porous structure layer and entity structure layer are by polymeric material
Material is made, and the elasticity modulus of entity structure layer is less than the elasticity modulus of the first porous structure layer and the bullet of the second porous structure layer
Property modulus.
Further, the elasticity modulus of the first porous structure layer is A, 100Mpa≤A≤800Mpa；Second porous structure layer
Elasticity modulus be B, 100Mpa≤B≤800Mpa；The elasticity modulus of entity structure layer is C, 10Mpa≤C≤100Mpa.
Further, the first porous structure layer is by one of polyurethane, polyvinyl alcohol gel or polylactic acid or a variety of systems
At；Second porous structure layer is by one of polyurethane, polyvinyl alcohol gel or polylactic acid or a variety of is made；Entity structure layer by
One of polyurethane, polyvinyl alcohol gel or polylactic acid a variety of are made.
Further, Invasive lumbar fusion device is to pass through the integrally formed structure of fusion sediment rapid shaping technique.
Further, the size of the hole in the first porous structure layer is 100 microns to 1000 microns, the first porous structure
The porosity of layer is that porosity is 40% to 80%；And/or the size of the second hole in porous structure layer is 100 microns
To 1000 microns, it is 40% to 80% that the porosity of the second porous structure layer, which is porosity,.
Further, the first porous structure layer is tetrahedron or hexahedral mesh structure；Second porous structure layer is four sides
Body or hexahedral mesh structure.
Further, the first porous structure layer is modified processing to surface by Plasma implantation techniques；And/or
Second porous structure layer is modified processing to surface by Plasma implantation techniques.
Further, Invasive lumbar fusion device is column structure, and the height of Invasive lumbar fusion device is 1mm to 30mm.
According to another aspect of the present invention, a kind of preparation method of Invasive lumbar fusion device is provided, above-mentioned intervertebral fusion is used for
Device, comprising: establish the threedimensional model of Invasive lumbar fusion device；By threedimensional model import slices software, intervertebral is set in Slice Software
The print conditions of fusion device generate mimeograph documents；Mimeograph documents are imported into FDM printer, to print vertebra by FDM printer
Between fusion device.
Further, preparation method further include: vulcanizing treatment is carried out to the Invasive lumbar fusion device printed.
Further, preparation method further include: the Invasive lumbar fusion device printed is carried out by Plasma implantation techniques
Surface modification treatment.
It applies the technical scheme of the present invention, the first porous structure layer, the second porous structure is provided in Invasive lumbar fusion device
Layer and entity structure layer, wherein the first porous structure layer and the second porous structure layer all have multiple holes, entity structure layer
Be arranged between the first porous structure layer and the second porous structure layer, also, the first porous structure layer, the second porous structure layer with
And entity structure layer is made of polymer material, the springform of the elasticity modulus of entity structure layer less than the first porous structure layer
The elasticity modulus of amount and the second porous structure layer.The first porous structure layer and the second porous structure layer energy with multiple holes
The tissues such as enough and patient terminal plate of vertebral body realize Bony union well；First porous structure layer, the second porous structure layer and
Entity structure layer is made of polymer material, has approximate consistency and elasticity, Ke Yiman with human body natural's physiology cartilage in this way
The support requirement of sufficient interverbebral disc and flexible deformation requirement；Moreover, this programme passes through the polymer material for controlling each structure sheaf
Molecular weight and the degree of cross linking adjust the elasticity modulus of each structure sheaf of Invasive lumbar fusion device, so that the elasticity modulus of entity structure layer is small
In the elasticity modulus of the first porous structure layer and the elasticity modulus of the second porous structure layer, can both Invasive lumbar fusion device be made to have
Good elasticity, and have enough support strengths.Therefore, the Invasive lumbar fusion device have good elastic property, after the implantation with
Skeleton has good amalgamation, can slow down or avoid the intervertebral disc degeneration of adjacent segment, guarantees late result.
Moreover, the first porous structure layer and the second porous structure layer are modified by fluoro plasma injection, can further mention
The bioactivity and Integrated implant ability of high upper and lower surface.Entity structure layer elasticity modulus is smaller, has elasticity, close to human body intervertebral
Disk biomechanical environment can share the pressure of adjacent segment centrum and interverbebral disc.
Detailed description of the invention
The accompanying drawings constituting a part of this application is used to provide further understanding of the present invention, and of the invention shows
Examples and descriptions thereof are used to explain the present invention for meaning property, does not constitute improper limitations of the present invention.In the accompanying drawings:
Fig. 1 shows the structural schematic diagram of the Invasive lumbar fusion device of the embodiment of the present invention offer.
Wherein, the above drawings include the following reference numerals:
10, the first porous structure layer；20, the second porous structure layer；30, entity structure layer.
Specific embodiment
Following will be combined with the drawings in the embodiments of the present invention, and technical solution in the embodiment of the present invention carries out clear, complete
Site preparation description.Obviously, described embodiments are only a part of the embodiments of the present invention, instead of all the embodiments.Below
Description only actually at least one exemplary embodiment be it is illustrative, never as to the present invention and its application or make
Any restrictions.Based on the embodiments of the present invention, those of ordinary skill in the art are not making creative work premise
Under every other embodiment obtained, shall fall within the protection scope of the present invention.
As shown in Figure 1, the embodiment provides a kind of Invasive lumbar fusion devices, comprising: the first porous structure layer 10, the
One porous structure layer 10 has multiple holes；Second porous structure layer 20, the second porous structure layer 20 have multiple holes；Entity
Structure sheaf 30, one end of entity structure layer 30 are connect with the first porous structure layer 10, the other end of entity structure layer 30 and second
Porous structure layer 20 connects；First porous structure layer 10, the second porous structure layer 20 and entity structure layer 30 are by polymer
Material is made, the elasticity modulus and the second porous structure of the elasticity modulus of entity structure layer 30 less than the first porous structure layer 10
The elasticity modulus of layer 20.
It applies the technical scheme of the present invention, the first porous structure layer 10, the second porous knot is provided in Invasive lumbar fusion device
Structure layer 20 and entity structure layer 30, wherein the first porous structure layer 10 and the second porous structure layer 20 all have multiple holes,
Entity structure layer 30 is arranged between the first porous structure layer 10 and the second porous structure layer 20, also, the first porous structure layer
10, the second porous structure layer 20 and entity structure layer 30 are made of polymer material, the elasticity modulus of entity structure layer 30
Less than the elasticity modulus of the first porous structure layer 10 and the elasticity modulus of the second porous structure layer 20.With multiple holes
One porous structure layer 10 and the second porous structure layer 20 can realize Bony union well with tissues such as the terminal plate of vertebral body of patient；
First porous structure layer 10, the second porous structure layer 20 and entity structure layer 30 are made of polymer material, in this way and people
Body nature physiology cartilage has approximate consistency and elasticity, can satisfy the support requirement and flexible deformation requirement of interverbebral disc；And
And the elasticity modulus of entity structure layer 30 is less than the elasticity modulus and second porous structure layer 20 of the first porous structure layer 10
Elasticity modulus can not only make Invasive lumbar fusion device have good elasticity, but also have enough support strengths.Therefore, the intervertebral fusion
Device has good elastic property, has good amalgamation with skeleton after the implantation, can slow down or avoid adjacent segments
The intervertebral disc degeneration of section guarantees late result.
In the present embodiment, the elasticity modulus of the first porous structure layer 10 is A, 100Mpa≤A≤800Mpa；Second is porous
The elasticity modulus of structure sheaf 20 is B, 100Mpa≤B≤800Mpa；The elasticity modulus of entity structure layer 30 be C, 10Mpa≤C≤
100Mpa.In this way, guaranteeing that Invasive lumbar fusion device has good supporting role, and retain certain elasticity, meets and be used for a long time
Reliability.
In the present embodiment, the first porous structure layer 10 by one of polyurethane, polyvinyl alcohol gel or polylactic acid or
It is a variety of to be made；Second porous structure layer 20 is by one of polyurethane, polyvinyl alcohol gel or polylactic acid or a variety of is made；Entity
Structure sheaf 30 is by one of polyurethane, polyvinyl alcohol gel or polylactic acid or a variety of is made.The above stability of material is good, and
Deformability and intensity meet long-time service demand.For example, the first porous structure layer 10, the second porous structure layer 20 and entity knot
Structure layer 30 is all made of polyurethane material.These materials have good ductility, breaking strength, wearability, biocompatibility, because
This can reach good combination with human tissue structure, it is ensured that the overall performance that prosthese is chronically implanted.
In the present embodiment, Invasive lumbar fusion device is by fusion sediment rapid shaping technique (FDM namely 3D printing) one
Molding structure.It is made of such mode, convenient for producing complicated porous structure, saving material and high-efficient.
In the present embodiment, the size of the hole in the first porous structure layer 10 is 100 microns to 1000 microns, more than first
The porosity of pore structure layer 10 is that porosity is 40% to 80%；And/or the size of the second hole in porous structure layer 20
It is 100 microns to 1000 microns, it is 40% to 80% that the porosity of the second porous structure layer 20, which is porosity,.It is set by above-mentioned
It sets, it can be achieved that good biology amalgamation, and it is good to have the first porous structure layer 10 and the second porous structure layer 20
Elasticity.In the present embodiment, porosity can be regarded as the volume of hole and the ratio of overall volume.
As shown in Figure 1, the first porous structure layer 10 is tetrahedron or hexahedral mesh structure；Second porous structure layer 20 is
Tetrahedron or hexahedral mesh structure.Using above-mentioned setting, it can be convenient for producing multi-pore structure and guarantee the first porous knot
The intensity of structure layer 10 and the second porous structure layer 20.
In the present embodiment, the first porous structure layer 10 is modified processing to surface by Plasma implantation techniques；
And/or second porous structure layer 20 by Plasma implantation techniques processing is modified to surface.It can further improve in this way
The bioactivity and Integrated implant ability of the upper and lower surface of first porous structure layer 10 and the second porous structure layer 20.
In the present embodiment, Invasive lumbar fusion device is column structure, and the height of Invasive lumbar fusion device is 1mm to 30mm.Specifically
Size and shape can be customized according to the actual conditions of patient.
In the present embodiment, entity structure layer 30 includes first part interconnected and second part, wherein first
Point thickness be greater than second part thickness, the two sides of first part respectively with the first porous structure layer 10 and the second porous structure
Layer 20 connects, and the two sides of second part are connect with the first porous structure layer 10 and the second porous structure layer 20 respectively.By above-mentioned
Setting, so that the shape of Invasive lumbar fusion device is more matched with the intervertebral anatomy of human body, convenient for implantation.
Invasive lumbar fusion device of the present invention is column structure, and altitude range is 1~30mm；By polyurethane material and its spread out
Biology is constituted, and upper and lower part is porous structure layer, and centre is entity structure, is passed through fusion sediment rapid shaping technique (FDM)
It is integrally formed, porous structure layer is with a thickness of 1~10mm；The porous structure layer of top and the bottom is modified by fluoro plasma injection, into
The bioactivity and Integrated implant ability of one step raising upper and lower surface.Upper and lower porous layer is modified by fluoro plasma injection, can be with
Realize Bone Ingrowth, with upper and lower vertebral fusion, formation is fixedly secured.Intermediate entities layer provides support and elasticity, close to human body intervertebral
Disk biomechanical environment shares the pressure of adjacent segment centrum and interverbebral disc.Porous structure layer network is tetrahedron or six
Face volume mesh, 100~1000 microns of aperture, porosity 40%~80%.Invasive lumbar fusion device of the invention passes through control polyurethane
Molecular weight and degree of cross linking control Invasive lumbar fusion device elasticity modulus, that is, guarantee that there is good supporting role, and retain certain
Elasticity.The elasticity modulus for the polyurethane that upper and lower porous layer uses is higher than intermediate entities layer, and control guarantees in 100~800Mpa
Porous structure layer supports terminal plate of vertebral body up and down enough；The control of intermediate entities layer elasticity modulus guarantees there is foot in 10~100Mpa
Enough elasticity.The material of two kinds of elasticity modulus is integrally formed by fusion sediment rapid shaping technique.
Another embodiment of the present invention provides a kind of preparation method of Invasive lumbar fusion device, is used for above-mentioned Invasive lumbar fusion device,
It include: the threedimensional model for establishing Invasive lumbar fusion device；By threedimensional model import slices software, intervertebral fusion is set in Slice Software
The print conditions of device generate mimeograph documents；Mimeograph documents are imported into FDM printer, are melted with printing intervertebral by FDM printer
Clutch.
Further, preparation method further include: vulcanizing treatment is carried out to the Invasive lumbar fusion device printed.
Further, preparation method further include: the Invasive lumbar fusion device printed is carried out by Plasma implantation techniques
Surface modification treatment.
The specific preparation process of the preparation method is as follows:
1) Invasive lumbar fusion device threedimensional model is established, porous structure layer and physical layer are divided, grid is carried out to porous structure layer
Filling, and stl file is exported as respectively；
2) porous structure layer and physical layer print conditions, including printed material and printing is set separately in import slices software
The parameters such as print temperature, print speed, the surface support form of machine generate mimeograph documents；
3) mimeograph documents are imported into more material FDM printers, by the parameter setting of porous structure layer and physical layer, completion is beaten
Print.Porous structure layer material, entity structure layer material and backing material are sent into corresponding nozzle by wire feeder, in nozzle
It is heated to molten condition, nozzle is done flat by the control of formation system according to the profile information and filling track that are set in advance
Face movement, and be equably laid in each layer cross section profile via the material that nozzle squeezes out, the silk material being extruded is in short-term
Interior rapid cooling, and be sticked together with upper one layer of cured material, layer upon layer ultimately generates required intervertebral fusion
Device.
4) then vulcanizing treatment, the vulcanization crosslinking 1~10 hour at a temperature of 90~120 DEG C improve the degree of cross linking, increase elasticity
Modulus.
5) surface is modified using fluoro plasma injection technique, uses carbon tetrafluoride as source ion implantation, note
Enter technological parameter are as follows: the pressure of working gas is 1.0 × 10-3Pa~1Pa, injecting voltage are 6~30kV, and injected pulse width is
10~1000 μ s, pulse recurrence frequency are 1~100Hz, and discharge current is 0.1~20A, and injection length is 0.5~20h.
According to the technical solution of the present invention, following technical effect may be implemented:
1) Invasive lumbar fusion device can retain the normal clearance and work between fusion centrum while with upper and lower vertebral fusion
Dynamic degree balance.
2) initial stability when coarse porous structure layer surface can provide fusion device implantation；The porous structure layer of top and the bottom
It injects and is modified by fluoro plasma, further increase the bioactivity and Integrated implant ability of upper and lower surface.Realization connects therewith
The spongiosa Bone Ingrowth of the centrum of touching, reaches fusion device with centrum and is permanently fixed；Entity structure layer can replace interverbebral disc alleviation
Backbone is impacted in the load stress of static(al) position or power position.
3) polyurethane material has good elasticity and wearability, high mechanical strength, good biocompatibility.
4) the problem of porous structure layer and entity structure layer are integrally formed, and conventional coatings removing will not occur.
The foregoing is only a preferred embodiment of the present invention, is not intended to restrict the invention, for the skill of this field
For art personnel, the invention may be variously modified and varied.All within the spirits and principles of the present invention, made any to repair
Change, equivalent replacement, improvement etc., should all be included in the protection scope of the present invention.
Claims (11)
1. a kind of Invasive lumbar fusion device characterized by comprising
First porous structure layer (10), first porous structure layer (10) have multiple holes；
Second porous structure layer (20), second porous structure layer (20) have multiple holes；
Entity structure layer (30), one end of the entity structure layer (30) is connect with first porous structure layer (10), described
The other end of entity structure layer (30) is connect with second porous structure layer (20)；
First porous structure layer (10), second porous structure layer (20) and the entity structure layer (30) are by poly-
It closes object material to be made, the elasticity modulus of the entity structure layer (30) is less than the elasticity modulus of first porous structure layer (10)
And the elasticity modulus of second porous structure layer (20).
2. Invasive lumbar fusion device according to claim 1, which is characterized in that
The elasticity modulus of first porous structure layer (10) is A, 100Mpa≤A≤800Mpa；
The elasticity modulus of second porous structure layer (20) is B, 100Mpa≤B≤800Mpa；
The elasticity modulus of the entity structure layer (30) is C, 10Mpa≤C≤100Mpa.
3. Invasive lumbar fusion device according to claim 1, which is characterized in that
First porous structure layer (10) is by one of polyurethane, polyvinyl alcohol gel or polylactic acid or a variety of is made；
Second porous structure layer (20) is by one of polyurethane, polyvinyl alcohol gel or polylactic acid or a variety of is made；
The entity structure layer (30) is by one of polyurethane, polyvinyl alcohol gel or polylactic acid or a variety of is made.
4. Invasive lumbar fusion device according to claim 1, which is characterized in that the Invasive lumbar fusion device is fast by fusion sediment
The fast integrally formed structure of forming technique.
5. Invasive lumbar fusion device according to claim 1, which is characterized in that
The size of hole in first porous structure layer (10) is 100 microns to 1000 microns, first porous structure
The porosity of layer (10) is that porosity is 40% to 80%；And/or
The size of hole in second porous structure layer (20) is 100 microns to 1000 microns, second porous structure
The porosity of layer (20) is that porosity is 40% to 80%.
6. Invasive lumbar fusion device according to claim 1, which is characterized in that
First porous structure layer (10) is tetrahedron or hexahedral mesh structure；
Second porous structure layer (20) is tetrahedron or hexahedral mesh structure.
7. Invasive lumbar fusion device according to claim 1, which is characterized in that
First porous structure layer (10) is modified processing to surface by Plasma implantation techniques；And/or
Second porous structure layer (20) is modified processing to surface by Plasma implantation techniques.
8. Invasive lumbar fusion device according to claim 1, which is characterized in that the Invasive lumbar fusion device is column structure, described
The height of Invasive lumbar fusion device is 1mm to 30mm.
9. a kind of preparation method of Invasive lumbar fusion device is used for Invasive lumbar fusion device described in any item of the claim 1 to 8, special
Sign is, comprising:
Establish the threedimensional model of the Invasive lumbar fusion device；
By the threedimensional model import slices software, the print conditions of the Invasive lumbar fusion device are set in the Slice Software,
Generate mimeograph documents；
The mimeograph documents are imported into FDM printer, to print the Invasive lumbar fusion device by the FDM printer.
10. preparation method according to claim 9, which is characterized in that the preparation method further include:
Vulcanizing treatment is carried out to the Invasive lumbar fusion device printed.
11. preparation method according to claim 9, which is characterized in that the preparation method further include:
Surface modification treatment is carried out to the Invasive lumbar fusion device printed by Plasma implantation techniques.
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