CN106913406A - A kind of spinal fusion device and preparation method thereof - Google Patents
A kind of spinal fusion device and preparation method thereof Download PDFInfo
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- CN106913406A CN106913406A CN201510991653.5A CN201510991653A CN106913406A CN 106913406 A CN106913406 A CN 106913406A CN 201510991653 A CN201510991653 A CN 201510991653A CN 106913406 A CN106913406 A CN 106913406A
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- 230000004927 fusion Effects 0.000 title claims abstract description 115
- 238000002360 preparation method Methods 0.000 title claims abstract description 15
- 238000000034 method Methods 0.000 claims abstract description 14
- 239000000560 biocompatible material Substances 0.000 claims abstract description 10
- 239000000463 material Substances 0.000 claims description 25
- 229910000861 Mg alloy Inorganic materials 0.000 claims description 11
- 238000000576 coating method Methods 0.000 claims description 9
- 239000011248 coating agent Substances 0.000 claims description 3
- 238000003780 insertion Methods 0.000 claims description 2
- 230000037431 insertion Effects 0.000 claims description 2
- 239000011148 porous material Substances 0.000 abstract description 12
- 210000000988 bone and bone Anatomy 0.000 description 31
- 238000005516 engineering process Methods 0.000 description 11
- 230000000694 effects Effects 0.000 description 9
- 238000002389 environmental scanning electron microscopy Methods 0.000 description 7
- 239000007943 implant Substances 0.000 description 7
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- 238000006731 degradation reaction Methods 0.000 description 6
- 230000003647 oxidation Effects 0.000 description 6
- 238000007254 oxidation reaction Methods 0.000 description 6
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 4
- 239000000956 alloy Substances 0.000 description 4
- 238000001727 in vivo Methods 0.000 description 4
- 229910052749 magnesium Inorganic materials 0.000 description 4
- 239000011777 magnesium Substances 0.000 description 4
- 230000003068 static effect Effects 0.000 description 4
- 230000012010 growth Effects 0.000 description 3
- 229910052588 hydroxylapatite Inorganic materials 0.000 description 3
- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 description 3
- 239000000047 product Substances 0.000 description 3
- 238000007493 shaping process Methods 0.000 description 3
- PWHULOQIROXLJO-UHFFFAOYSA-N Manganese Chemical compound [Mn] PWHULOQIROXLJO-UHFFFAOYSA-N 0.000 description 2
- 229920001244 Poly(D,L-lactide) Polymers 0.000 description 2
- 229910045601 alloy Inorganic materials 0.000 description 2
- 230000008468 bone growth Effects 0.000 description 2
- 229910010293 ceramic material Inorganic materials 0.000 description 2
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- 238000005260 corrosion Methods 0.000 description 2
- 230000007812 deficiency Effects 0.000 description 2
- 229920002521 macromolecule Polymers 0.000 description 2
- 229910052748 manganese Inorganic materials 0.000 description 2
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- 229910052751 metal Inorganic materials 0.000 description 2
- 239000002184 metal Substances 0.000 description 2
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- 229920000642 polymer Polymers 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- 150000003751 zinc Chemical class 0.000 description 2
- 206010056377 Bone tuberculosis Diseases 0.000 description 1
- 208000002607 Pseudarthrosis Diseases 0.000 description 1
- 229910000883 Ti6Al4V Inorganic materials 0.000 description 1
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 210000001124 body fluid Anatomy 0.000 description 1
- 239000010839 body fluid Substances 0.000 description 1
- 230000037118 bone strength Effects 0.000 description 1
- 229910000389 calcium phosphate Inorganic materials 0.000 description 1
- 239000001506 calcium phosphate Substances 0.000 description 1
- 235000011010 calcium phosphates Nutrition 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 230000009194 climbing Effects 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 238000013170 computed tomography imaging Methods 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 239000007857 degradation product Substances 0.000 description 1
- 230000003111 delayed effect Effects 0.000 description 1
- 238000000280 densification Methods 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 208000035475 disorder Diseases 0.000 description 1
- 230000002708 enhancing effect Effects 0.000 description 1
- RTZKZFJDLAIYFH-UHFFFAOYSA-N ether Substances CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 description 1
- -1 ether ketone Chemical class 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 238000013467 fragmentation Methods 0.000 description 1
- 238000006062 fragmentation reaction Methods 0.000 description 1
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 1
- 239000010931 gold Substances 0.000 description 1
- 229910052737 gold Inorganic materials 0.000 description 1
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- 231100000915 pathological change Toxicity 0.000 description 1
- 230000036285 pathological change Effects 0.000 description 1
- 229920000570 polyether Polymers 0.000 description 1
- 230000002980 postoperative effect Effects 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 230000035755 proliferation Effects 0.000 description 1
- 238000007634 remodeling Methods 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 108010048734 sclerotin Proteins 0.000 description 1
- 238000004062 sedimentation Methods 0.000 description 1
- 210000004872 soft tissue Anatomy 0.000 description 1
- 238000005507 spraying Methods 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 230000003319 supportive effect Effects 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 239000010936 titanium Substances 0.000 description 1
- 229910052719 titanium Inorganic materials 0.000 description 1
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 1
Classifications
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0023—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in porosity
- A61F2250/0024—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in porosity made from both porous and non-porous parts, e.g. adjacent parts
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
The present invention discloses a kind of spinal fusion device, and the spinal fusion device includes a supporter, and the supporter forms a receiving space, and a hole shape structure is at least partly included in the receiving space.Present invention simultaneously discloses a kind of preparation method of spinal fusion device, the method comprising the steps of：(1) a biocompatible material block is processed into a preset shape, some holes is being prepared near the biocompatible material block center, the biocompatible material block is formed a supporter and a pore structure.
Description
Technical field
The present invention relates to medical instruments field.Relate more specifically to a kind of spinal fusion device and preparation method thereof and
Purposes.
Background technology
Spinal fusion is one of clinically the most frequently used modus operandi at present, be treatment tuberculosis of spine, infection,
The effective means of the spine disorderses such as deformity, retrogression pathological changes and intervertebral disk injury.It is mainly by intervertebral
Gap is implanted into Invasive lumbar fusion device, while be implanted into substantial amounts of autologous bone or homogeneous allogenic bone, so as to realize centrum between melt
Close, reach the purpose of stabilization backbone.
The material of current fusion device is mainly nondegradable metal Ti6Al4V materials and macromolecular material polyethers
Two kinds of ether ketone (PEEK), the former has preferable histocompatbility, is capable of achieving Bony union, but postoperative gold
Category is retained in vivo all the life, the puzzlement of permanent retention and the possibility of second operation is increased, due to springform
The conference of amount difference produces a certain degree of stress shielding, and fusion bone strength and quality are had a certain impact, and
A certain degree of sedimentation can be produced, so as to easily form the disadvantage that interspinous support is highly lost.PEEK fusion devices
It is the focus of research in recent years, its good biocompatibility is small to X-ray and CT Imagings, but bone
Foreign matter is regarded as during remodeling process, and is isolated with fibr tissue capsule, such fibr tissue resistance
Only direct bone apposition (apposition) and the attachment to implant, implant will not be completely coupled in bone
And soft tissue will not be attached on implant, cause bone-material interface bond strength not enough, be susceptible to
Loosen.The surface of PEEK fusion devices is modified (such as in surface spraying titanium valve, hydroxyapatite (HA), to be utilized
The micropore spline structure induction bone tissue of coating grows into) although solving bone-material interface knot to a certain extent
The not enough problem of intensity is closed, but face coat is in the case where physiological environment is plus load effect, still may be by body
Absorb or due to stress concentration, cracked with the interface of ground along porous vesicular surface, cause and come off.Therefore
There is the deficiency of itself in PEEK fusion devices.
Due to the deficiency that non-degradable material is present, also there is fusion device of the research on some degradation materials to produce
Product, including ceramic material TCP fusion devices and macromolecule PDLLA fusion devices.Fusion prepared by ceramic material
The fusion device of the device such as preparation such as calcium phosphate, hydroxyapatite allows direct bone apposition, but they are in intensity
It is restricted with toughness, it is easily chipping.PDLLA fusion devices have the elastic modelling quantity close with sclerotin,
Degradable is the product that can be absorbed by the body, so that gradually absorbed and substituted by bone tissue, with good
Good bioactivity, in the absence of bone-material interface problem, but its mechanical strength is relatively low, in operation technique
It is easy to fragmentation；And its early stage macromolecules degradation product can cause surrounding materials proliferation of fibrous tissue, certain journey
Degree has delayed early stage skeletonization.
Spinal fusion device conventional at present implantation intervertenral space mainly plays a supportive role in addition, it is impossible to induced osteogenesis,
Therefore generally require to be implanted into autologous bone or homogeneous allogenic bone in fusion device, to reach the purpose of Bony union,
Autologous bone needs to be taken out from the body of patient, often brings very big pain to patient's body and mind, and of the same race
Allograph bone is not only expensive, and syncretizing effect is also undesirable, Post lumbar surgery pseudarthrosis often occurs and is formed
Deng the situation that lumbar vertebrae is not merged.
Therefore this area in the urgent need to provide one kind can degradation in vivo completely, it is strong with preferable mechanics
Degree, elastic modelling quantity is approached with body bone tissue, while having self-bone grafting function, it is possible to achieve even without plant
Bone or minimal amount of bone grafting can just reach the fusion device of good bone fusion effect.
The content of the invention
The present invention is intended to provide one kind can degradation in vivo completely, with preferable mechanical strength, springform
Amount is approached with body bone tissue, while there is the fusion device of self-bone grafting function and its production and use.
In order to realize foregoing invention purpose, the present invention provides a kind of spinal fusion device, and the spinal fusion device includes one
Supporter, the supporter forms a receiving space, and the receiving space partially or fully fills a hole shape structure.
Further, the supporter is made up with the hole shape structure of same material.The supporter and the hole
Shape structure is made up of magnesium alloy.The hole shape structure is multiple through holes.The height of the hole shape structure is the supporter
The 50% to 100% of height.The supporter includes an inner surface and an outer surface, and it is empty that the inner surface forms the receiving
Between, the hole shape structure is connected with the inner surface, and the inner surface is 1.5mm to 4.5mm with the thickness of outer surface.
With the total volume meter of the fusion device, the volume percentage of the hole shape structure is 30-80%.The hole shape knot
The shape of cross section of the macropore in structure is one kind or the combination of following shapes：Circle, arc, it is square, oval,
Triangle, regular hexagon.
In another preference, some through holes are also included on the supporter, the through hole runs through the outer of the supporter
Surface and inner surface.
In another preference, the supporter includes a small aperture layer, the small aperture layer with the surface of the hole shape structure
Bore dia be 1-50 μm.Include a bioactivity coatings in the small aperture layer.
Present invention simultaneously discloses a kind of preparation method of spinal fusion device, the method comprising the steps of：(1) will all one's life
Thing compatible material block is processed into a preset shape, and some holes are prepared the biocompatible material block center is close to,
The biocompatible material block is set to form a supporter and a hole shape structure.
The method is further included：(2) a small aperture layer is formed on the surface of the supporter and the hole shape structure.
The method is further included：(3) bioactivity coatings are formed in the small aperture layer.
In another preference, the step (1) is further included：Some through holes are prepared on the supporter, should
The through hole insertion supporter and/or the hole shape structure.
Compared with prior art, the spinal fusion device that the present invention is provided can be reduced or avoid human body from planting
Bone, greatly reduces the operation risk and pain of patient.The spinal fusion device that the present invention is provided is due to using life
The good degradable magnesium alloy material of thing compatibility, the low effective reduction stress-shielding effect of elastic modelling quantity.The present invention
The spinal fusion device of offer is high-strength porous, and its static compress rigidity meets up to 20kN/mm-30kN/mm
Clinically it is more than the use requirement of 18kN/mm.The internal macropore of spinal fusion device use of present invention offer,
The pore structure that surface aperture is combined with each other, surface fine pore structure causes that cell tissue is easily adhered growth,
Macroporous structure is conducive to creeping and connecting for cell, as the degraded bone tissue of fusion device constantly grows into, finally
Realize complete Bony union.
Brief description of the drawings
Fig. 1 is the structural representation of the spinal fusion device 100 that one embodiment of the invention is related to；
Fig. 2 is the structural representation of the spinal fusion device 200 that one embodiment of the invention is related to；
Fig. 3 is the structural representation of the spinal fusion device 300 that one embodiment of the invention is related to；
Fig. 4 is the structural representation of the spinal fusion device 400 that one embodiment of the invention is related to；
Fig. 5 is the structural representation of the spinal fusion device 500 that one embodiment of the invention is related to；
Fig. 6 is the macropore pore appearance figure under the spinal fusion device ESEM that the present invention is provided；
Fig. 7 is the surface small structure shape appearance figure under the spinal fusion device ESEM that the present invention is provided；
Fig. 8 is to before and after the spinal fusion device surface plasma oxidation processes that provide in one embodiment of the invention
Dynamic potential polarization curve；
Fig. 9 is that having for one embodiment of the invention offer is big under the spinal fusion device ESEM of circular macropore
Hole；
Figure 10 is the structure and morphology figure of the surface aperture of the circular macropore shown in Fig. 9.
Figure 11 is that having for one embodiment of the invention offer is big under the spinal fusion device ESEM of square macropore
Pore structure SEM shape appearance figures.
Figure 12 is the table under the spinal fusion device ESEM of the square macropore of tool that one embodiment of the invention is provided
Face small structure SEM shape appearance figures.
Mainly illustrate
100th, 200,300,400,500-spinal fusion device
101st, 201,301,401,501-upper surface (the first face)
102nd, 202,302-lower surface (relative with the first face)
103rd, 203,303,403,503-macroporous structure
304-small 305-mounting hole of groove, 306-corrugated teeth
507a-outer surface 507b-508-macropore of inner surface
Specific embodiment
Inventor prepares and can be used for the Invasive lumbar fusion device of spinal fusion by in-depth study extensively,
And if it was found that make fusion device middle part have a series of macropore, can aid in creeping and connecting for cell, and
The aperture on fusion device surface can make cell tissue be easily adhered growth, this mutually to be tied with large and small pore structure
The fusion device of conjunction can degradation in vivo completely, with preferable mechanical strength, elastic modelling quantity and human body bone group
Knit close, while having self-bone grafting function, it is possible to achieve can just reach even without bone grafting or minimal amount of bone grafting
To the fusion device of good bone fusion effect.On this basis, the present invention is completed.
Spinal fusion device
Vertebral fusion device of the invention can have any suitable shape, and including any suitable biofacies
Capacity materials.Suitable shape is for example including substantially cylindrical in shape, annular, dish type, rectangle, U-shaped, boomerang shape etc.
Shape, it is dimensioned to be used for neck, chest or waist.Suitable biocompatible material includes metal, modeling
Material, resorbable polymers, polymer composites, bone grafting material etc. can be reabsorbed.
The present invention provides a kind of spinal fusion device for being implanted between two adjacent vertebraes, the institute in a kind of mode
Fusion device is stated for one similar to cylinder spinal fusion device 100, its inside has to be led to and its phase from the first face 101
To the second face 102 loose structure 103, pore structure here is macropore.Loose structure provided by the present invention
In addition to being the macropore for leading to the second face 102 corresponding thereto from the first face 101, can also be other single
Dead-end pore, such as tree root shape hole, sponge-type porosity.
In the present invention, " macropore ", " through hole ", " macroporous structure " or " hole shape structure " refer to
Pore structure of the aperture at 100-500 μm in the spinal fusion device that the present invention is provided, preferably aperture are 200-500 μ
m。
Fig. 2 is square spinal fusion device 200 provided by the present invention.Fig. 3 is class provided by the present invention
It is similar to a trapezoidal spinal fusion device 300.The spinal fusion device 300 includes the supporter positioned at outside, should
Supporter includes upper surface 301 and lower surface 302 corresponding thereto.Supporter is made up of compact texture, uses
In the mechanical strength that clinical requirement is met to provide, by taking magnesium, manganese or magnesium, zinc series alloy as an example, the support
The static compress rigidity that body can be provided is more than 18kN/mm.In the middle of supporter is macroporous structure 303,
The macroporous structure can be effectively promoted newborn Bone Ingrowth, improve its adhesion with surrounding tissue, so as to avoid
The loose shift of implant, and can greatly improve the exchange of body fluid inside and outside implant.
Corrugated teeth 306 is provided with the upper surface 301 of supporter and lower surface 302, for improving implant
The stability with vertebra support itself.In order to further improve fixed effect, can also be on corrugated teeth 306
Small groove 304 is set.
In this embodiment, the upper surface of macroporous structure 303 is almost located at same with the upper surface 301 of supporter
One plane, and the lower surface of macroporous structure 303 is almost generally aligned in the same plane with the lower surface 302 of supporter.
Advantage of this is that the mechanical strength of the spinal fusion device is increased, and can be when using on human body
Unsuitable bone grafting.
In another embodiment, spinal fusion device 400 as shown in Figure 4, the entirety of macroporous structure 403
Highly less than the whole height of supporter, the centre of supporter is may be located at or near upper surface 401 or following table
Face 402.The advantage of the embodiment is that can accelerate bone uptake speed by appropriate, a small amount of bone grafting.
The height of macroporous structure mesopore is first face (upper surface described in the spinal fusion device that the present invention is provided
Or lower surface) 50-100% of air line distance and the second face (lower surface or upper surface) corresponding thereto between；With
The total volume meter of the fusion device, the volume percentage of the macroporous structure is 30-80%.
Percent by volume in the spinal fusion device that the present invention is provided shared by macroporous structure is too small or does not conform to mostly excessively
It is suitable, it is too small to play the effect for making enough bone tissues constantly grow into of the present invention, therefore at least 30
%；The excessive intensity then to fusion device is unfavorable, so most 80%；It is preferred that 40-70%, more preferably 50-60%.
Hole shape in the spinal fusion device that the present invention is provided in macroporous structure for example but can not limited with various
In circle, arc, triangle, square, oval, honeycombed etc. are also not necessarily limited to above-mentioned geometric figure institute group
Into figure, such as the sector that arc and triangle are formed.
Macropore and aperture pore appearance figure under fusion device ESEM can respectively referring to accompanying drawing 6-12.
In one embodiment of the invention, the macroporous structure is not only in the inside of fusion device, it is also possible at it
Surface.Spinal fusion device 500 as shown in Figure 5, macroporous structure 508 can be arranged on the part of the supporter
Or whole sides.In one embodiment, have some between the outer surface 507a to inner surface 507b of supporter
Equally distributed macropore 508, in actually preparing, the macropore 508 can be even placed through in the middle of supporter
Macroporous structure 503.
In a preferred embodiment of the invention, the outer surface 507a of supporter is to inner surface 507b thickness
1.5mm to 4.5mm.It has been investigated that, the spinal fusion device in the thickness range can realize clinical requirement
Mechanical strength and can to greatest extent promote new bone growth.
The spinal fusion device that the present invention is provided is respectively provided with some apertures on the surface of supporter and macroporous structure, or
A small aperture layer is formed, bioactivity coatings are coated in small aperture layer also can effectively induce ostosis.
In another embodiment of the invention, fusion device surface is except carrying out being conducive to inducing ostosis
Bioactivity coatings, can also coat makes the enhanced material of surface corrosion resistance to reduce degradation rate.
In the present invention, " aperture ", " small structure " or " surface aperture " refers to be provided in the present invention
The hole on spinal fusion device surface, general aperture is 1-50 μm.The side of such aperture is formed on fusion device surface
Formula is included but is not limited to, plasma oxidation technology, and voltage is that 400-500V prepares surface small structure.
The constituent material of the spinal fusion device that the present invention is provided is magnesium alloy, and chemical composition is mainly with biofacies
The element of capacitive, such as but not limited to, magnesium, manganese or magnesium, zinc series alloy, its static compress rigidity is up to 20
KN/mm-30kN/mm, mechanical strength meets clinical demand.
Preparation method
The preparation method of the spinal fusion device that the present invention is provided includes step：
Step one：The macroporous structure that footpath is for 100-500 μm is prepared at the middle part of the fusion device；
Step 2：The aperture that aperture is for 1-50 μm is prepared on the fusion device.
Specifically, the preparation method of the spinal fusion device includes split-type structural and integrally formed structure.With split
As a example by preparation method, a supporter can be first made, the support body material can be any suitable bio-compatible material
Material.A macroporous structure is made, and the macroporous structure is positioned in the supporter, the mode of placement can be interference
Cooperation, screw thread, spline etc..
The preparation method of integrally formed structure includes：According to the preset shape of the spinal fusion device (such as circular, side
Shape, dish type etc.) machining one magnesium alloy block or other biological compatible material.Used on the magnesium alloy block for processing and swashed
Light prepares some through holes, the magnesium alloy block is formed the supporter and a loose through-hole structure of a densification.If needed
Increase through hole is carried out on supporter, can continue to prepare through hole with laser technology.Using plasma oxidation technology,
Voltage is 400-500 volts forms the aperture that aperture is for 1-50 μm on surface.The sample for finally preparing carries out table
Face activity treatment, the bioactivity coatings for preparing different-thickness on surface can induce bone growth while controlling degraded
Speed.
Purposes
The spinal fusion device that the present invention is provided can be used as intervertebral implant or further adding for Related product
Work.
The features described above that the present invention is mentioned, or the feature that embodiment is mentioned can be in any combination.This case specification institute
The all features for disclosing can be used in combination with any combinations thing form, and each feature disclosed in specification can be with any
The alternative characteristics substitution of identical, impartial or similar purpose can be provided.Therefore removing has special instruction, disclosed spy
Levy the general example of only impartial or similar features.
Main advantages of the present invention are：
1st, the present invention provide spinal fusion device due to using good biocompatibility degradable magnesium alloy material,
The low effective reduction stress-shielding effect of elastic modelling quantity.
2nd, the spinal fusion device that the present invention is provided is high-strength porous, and its static compress rigidity is reachable
20kN/mm-30kN/mm, meets the use requirement clinically more than 18kN/mm.
3rd, the hole knot that the spinal fusion device that the present invention is provided is combined with each other using internal macropore, surface aperture
Structure, surface fine pore structure causes that cell tissue is easily adhered growth, and macropore gauge structure is conducive to climbing for cell
Row and connection, as the degraded bone tissue of fusion device constantly grows into, finally realize complete Bony union.
With reference to specific embodiment, the present invention is expanded on further.It should be understood that these embodiments are only used for
The bright present invention rather than limitation the scope of the present invention.The experiment side of unreceipted actual conditions in the following example
Method, generally according to normal condition or according to the condition proposed by manufacturer.Unless otherwise indicated, otherwise institute
Some percentage, ratio, ratio or number are by weight.
The unit in percent weight in volume in the present invention be it is well-known to those skilled in the art, e.g.
Refer to the weight of the solute in 100 milliliters of solution.
Unless otherwise defined, all specialties used in text are ripe with one skilled in the art institute with scientific words
The meaning known is identical.Additionally, any method similar to described content or impartial and material all can be applied to
In the inventive method.Preferable implementation described in text only presents a demonstration with material and is used.
Embodiment 1
Spinal fusion device 200
As shown in Fig. 2 middle 400 microns of 210 aperture of macropore loose structure of fusion device 200, hole is circle
Shape, small-bore is 1-40 microns, and hole depth is consistent with fusion device depth.
Fusion device material uses M1C magnesium alloys, is integrally machined shaping, and prepare macropore using laser technology
Structure.Plasma oxidation technology is finally used, voltage is that 450V prepares surface small structure.
Shown in the visible accompanying drawing 8 of macropore and aperture pore appearance of the fusion device under ESEM.
Shown in the visible accompanying drawing 9 of dynamic potential polarization curve before and after fusion device surface treated, as a result display surface
After treatment, coating corrosion resistance enhancing, degradation rate reduction.
Embodiment 2
Spinal fusion device 400
As shown in figure 4, middle 500 microns of 410 aperture of macropore loose structure of fusion device 400, hole is circle
Shape, small-bore is 1-50 microns, and pattern is consistent with Fig. 2, and hole depth is the 2/3 of fusion device depth.
Fusion device material uses ZK60 magnesium alloys, is integrally machined shaping, and prepare macropore using laser technology
Structure.Plasma oxidation technology is finally used, voltage is that 500V prepares surface small structure.
Embodiment 3
Spinal fusion device 500
As shown in figure 5, in the middle of fusion device 500 and 450 microns of periphery loose structure aperture, bone tissue can be with
Growing into from all directions, hole is circle, and middle hole depth is the 1/2 of fusion device depth.Small-bore is 1-40
Micron
Fusion device material uses MIC magnesium alloys, is integrally machined shaping, and prepare macropore knot using laser technology
Structure.Plasma oxidation technology is finally used, voltage is that 475V prepares surface small structure.
Presently preferred embodiments of the present invention is the foregoing is only, substantial technological of the invention is not limited to
Context, substantial technological content of the invention is broadly to be defined in the right of application, is appointed
What other people technology entities that complete or method, if with phase completely defined in the right of application
Together, also or a kind of equivalent change, will be considered as being covered by among the right.
Claims (15)
1. a kind of spinal fusion device, it is characterised in that the spinal fusion device includes a supporter, the supporter
A receiving space is formed, the receiving space partially or fully fills a hole shape structure.
2. spinal fusion device as claimed in claim 1, it is characterised in that, the supporter and the hole shape knot
Structure is made up of same material.
3. spinal fusion device as claimed in claim 1 or 2, it is characterised in that, the supporter and the hole
Shape structure is made up of magnesium alloy.
4. spinal fusion device as claimed in claim 1, it is characterised in that, the hole shape structure is multiple logical
Hole.
5. spinal fusion device as claimed in claim 1, it is characterised in that, the height of the hole shape structure is institute
State the 50% to 100% of supporter height.
6. spinal fusion device as claimed in claim 1, it is characterised in that, the supporter include an inner surface and
One outer surface, the inner surface forms the receiving space, and the hole shape structure is connected with the inner surface, institute
It is 1.5mm to 4.5mm that inner surface is stated with the thickness of outer surface.
7. spinal fusion device as claimed in claim 1, it is characterised in that, the supporter and the hole shape knot
The surface of structure includes a small aperture layer, and the bore dia of the small aperture layer is 1-50 μm.
8. spinal fusion device as claimed in claim 7, it is characterised in that include that is biological in the small aperture layer
Active coating.
9. spinal fusion device as claimed in claim 1, it is characterised in that with the total volume meter of the fusion device,
The volume percentage of the hole shape structure is 30-80%.
10. spinal fusion device as claimed in claim 4, it is characterised in that, the hole shape of the through hole is following
One kind of shape or combination：Circle, arc, square, oval, triangle, regular hexagon.
11. spinal fusion devices as claimed in claim 1, it is characterised in that, the supporter includes an inner surface
And an outer surface, the inner surface forms the receiving space, and the hole shape structure is connected with the inner surface,
Also include some through holes on the supporter, the through hole runs through outer surface and the inner surface of the supporter.
12. a kind of preparation methods of spinal fusion device, it is characterised in that methods described includes step：
(1) a biocompatible material block is processed into a preset shape, in the biocompatible material block
Some holes are prepared at the heart, the biocompatible material block is formed a supporter and a hole shape structure.
13. preparation methods as claimed in claim 12, it is characterised in that methods described is further included：
(2) a small aperture layer is formed on the surface of the supporter and the hole shape structure.
14. preparation methods as claimed in claim 13, it is characterised in that methods described is further included：
(3) bioactivity coatings are formed in the small aperture layer.
15. preparation methods as claimed in claim 12, it is characterised in that the step (1) further includes：
Some through holes are prepared on the supporter, supporter described in the through hole insertion and/or the hole shape structure.
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| CN201510991653.5A CN106913406A (en) | 2015-12-25 | 2015-12-25 | A kind of spinal fusion device and preparation method thereof |
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| CN110393614A (en) * | 2019-08-10 | 2019-11-01 | 山东百多安医疗器械有限公司 | A kind of porous bionical cervical fusion cage |
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