CN106943213A - A kind of bionical Invasive lumbar fusion device - Google Patents
A kind of bionical Invasive lumbar fusion device Download PDFInfo
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- CN106943213A CN106943213A CN201611083348.7A CN201611083348A CN106943213A CN 106943213 A CN106943213 A CN 106943213A CN 201611083348 A CN201611083348 A CN 201611083348A CN 106943213 A CN106943213 A CN 106943213A
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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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- 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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
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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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00035—Other metals or alloys
- A61F2310/00131—Tantalum or Ta-based alloys
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- Orthopedic Medicine & Surgery (AREA)
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- Oral & Maxillofacial Surgery (AREA)
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Abstract
The present invention relates to a kind of bionical Invasive lumbar fusion device.It includes fusion device main body, it is characterised in that：The fusion device main body is divided into top（5）, middle part（6）And bottom（7）Three layers；The top（5）Upper surface and the bottom（7）Lower surface be convexity arc surface；The middle part（6）Two opposite flanks be provided with multi-row staggered distribution through hole（8）；The top（5）With the bottom（7）It is made by porous metal material.Structure of the present invention simplifies, stable connection, and elastic modelling quantity is suitable, and has certain toughness concurrently.
Description
Technical field
The present invention relates to a kind of intervertebral fixation device, more particularly to a kind of bionical Invasive lumbar fusion device.
Background technology
At present, it is unstable between disc herniation and centrum caused by backbone regression, it is the common disease that today's society perplexs the mankind
And frequently-occurring disease.In this regard, clinically by the modus operandi of implantable artificial Invasive lumbar fusion device be at present frequently with selection, it is not only
The effect of intervertebral fusion can be greatly improved, while so that normal level becomes possibility between maintaining centrum.
Although implantation Invasive lumbar fusion device can obtain more satisfied short term efficacy, it is still suffered from：Product early stage is implanted into
Rear stability is poor, often needs lock screw auxiliary fixation, complex structure；The elastic modelling quantity of product is higher, the elasticity with centrum
Modulus gap is excessive, and the later stage produces stress shielding, causes bone information, bone deterioration and upper hypocentrum abnormal motion or regression；Bone group
Knit and cannot be introduced into inside it, do not reach good Integrated implant, bond strength is not high, easily loosen；The toughness of product is poor, in external force
Effect is lower or overly hard or the technical barrier such as is easily deformed.In addition, existing Invasive lumbar fusion device product also generally existing selection
Biocompatibility is poor, it is impossible to meet blood, the infiltration of tissue fluid, transmission, can not also realize protein degradation products and new old
The discharge of metabolite, causes its own can not realize this technical barrier of bio-regeneration.
For above section technical barrier, the Invasive lumbar fusion device set in existing report using loose structure.Although
The Invasive lumbar fusion device of loose structure have can be acted on by induced osteogenesis so that bone tissue is grown into, with increase biocompatibility and
Bond strength, and by controlling the parameters such as aperture and porosity come regulation elasticity modulus, to avoid generation stress shielding etc. many
Usefulness, but existing porous material structure is relatively simple, mostly single uniform pores, it is impossible to meet a variety of function need
Ask, such as its pore size and connectedness is difficult to control to, this will prevent material from fully, be accurately finished required function.
In recent years, new multistage Porous materials, due to its unique performance, it has also become the focus studied in the world.Multi-stage porous
Material has the advantage in holes at different levels, and have the advantage not available for the material in single hole, such as, have with three-dimensional simultaneously simultaneously
The molecular sieve of foramen magnum-mesoporous-microcellular structure of sequence, combines multi-stage artery structure and both nanocrystalline advantages of molecular sieve, assigns
The three-dimensional open-framework that molecular sieve is more open is given, while nano molecular sieve crystal substantially reduces mass transfer path, effectively
Ground improves the catalytic activity of gained molecular sieve.But the pore structures at different levels in existing multilevel hole material, its structure are set not
Rationally, the size in holes at different levels really can not be effectively controlled in preparation process, therefore can not met as Bionic bone dummy
Functional requirement.In addition, as biomimetic artificial bone, need its material uniform in itself in the application, i.e., pore size, hole distribution it is equal
It is even so that performance uniformity, but in fact, mostly multilevel hole material do not reach the requirement, its lack of uniformity；In spite of
Material, which is called oneself, has reached higher uniformity, but its uniformity is still the uniformity under large volume yardstick, if using small size yardstick
Measurement comparison is carried out, such as takes up an official post the said three-dimensional body that takes polylith volume to be not more than one cubic centimetre in material, its quality is surveyed respectively, its
Degree of irregularity difference is still very big, therefore causes the inequality of various performances such as intensity, elastic modelling quantity etc. of multilevel hole material
It is even, so as to have a strong impact on its function.
The content of the invention
It is an object of the invention to provide a kind of bionical Invasive lumbar fusion device, its structure simplifies, and elastic modelling quantity is suitable, and connection is steady
Gu.
Objects of the present invention are achieved through the following technical solutions：
A kind of bionical Invasive lumbar fusion device, including fusion device main body, it is characterised in that：The fusion device main body be divided into top,
Three layers of middle part and bottom；The lower surface of the upper surface on the top and the bottom is convexity arc surface；Two of the middle part
Opposite flank is provided with the through hole of multi-row staggered distribution；The top and the bottom are made by porous metal material.
Optimize as further, on above-mentioned middle part on two other relative side adjacent with the side provided with through hole,
It is provided with clamping hole.
As further optimization, above-mentioned clamping hole leads to adjacent two row in the middle part of the through hole of above-mentioned multi-row staggered distribution
Hole is mutually communicated.By the way that adjacent two exhausting hole in the middle part of the through hole of multi-row staggered distribution is be combined with each other insertion with clamping hole
Set, impart the certain toughness of fusion device main body, make its not only tough and tensile but also high resilience, be conducive to bearing external force effect.
As further optimization, above-mentioned clamping hole is two.
As further optimizing, in order that obtaining the bionical Invasive lumbar fusion device has excellent biocompatibility, make its
It is implanted into after tissue, guides biological tissue uniformly to grow into an orderly manner, to meet blood, the infiltration of tissue fluid, transmission, realizes egg
The discharge of white matter catabolite and metabolism product, makes it just truly show bio-regeneration, above-mentioned porous metal material is preferably adopted
Multistage porous metal material is used, with three-level hole, its material body is the vestibule being classified with material pore size, and is surrounded
The cavity wall for forming vestibule is constituted；Wherein, it is uniformly distributed in the cavity wall for the first order vestibule be uniformly distributed, being mutually communicated, mutually
There is the third level vestibule for being uniformly distributed, being mutually communicated in the second level vestibule of insertion, the cavity wall of second level vestibule；And vestibules at different levels
Mutual also insertion each other, described insertion is three-dimensional insertion；Every grade of porous material is porous per one-level from being a continuous structure body
The maximum external boundary of material is suitable with the space boundary of whole material body, and every grade of porous material has materialization alone
Energy.Such structure can cause the physical and chemical performances of porous materials at different levels difference, in the whole space of relatively-stationary material
In have different physical and chemical performances, preferably meet many unique function demands.
As further optimizing, above-mentioned multistage porous metal material, with the hole of a specific dimensions scope of one-level vestibule
Quantity account for more than the 80% of this grade of hole sum, so as to so that the pore size size of same level vestibule is in a specific dimensions model
Enclose the special requirement that concentration degree is high, makes it meet the specific dimensions vestibule of needs one.
More specifically, above-mentioned multistage porous metal material, its each vestibule arbitrary unit on multistage porous metal material
It is in uniform distribution under level volume, wherein, unit level volume refers to cubic millimeter level or more subsection level volume；Vestibule is in equal
The distribution of even property refer to the multistage porous metal material take up an official post the volume that takes be not more than 1 cubic millimeter formed objects each three-dimensional
Body, their quality is substantially suitable；Quality quite refers to little in take up an official post multiple volumes for taking of multistage porous metal material substantially
In the said three-dimensional body of 1 cubic millimeter of formed objects, its quality is claimed respectively, the average value of their quality is obtained, and any said three-dimensional body
Quality is not more than the 4% of said three-dimensional body mass average value relative to the absolute value of the bias of mass average value.
Above-mentioned multistage porous metal material, can be the metal material of single-element composition, or alloy material.Example
Such as, titanium, tantalum, titanium alloy material etc. be can select.
The middle part of above-mentioned fusion device main body is made of fine and close medical metal material, and molten by laser welding or electron beam
The usual manner such as melt, respectively realize and to be fixedly connected with the upper and lower part of above-mentioned fusion device main body.
The present invention has following beneficial effect：
(1) the invention provides a kind of bionical Invasive lumbar fusion device, its structure simplifies, and the upper and lower part of fusion device main body is adopted
Use convexity arc surface structure, it is not easy to produce slip, improve implantation early stage stability, and cavernous body structure surface provide compared with
Big frictional force, further enhancing stability；The middle part of fusion device main body uses compact metal material, to connect top and the bottom,
Both the brittle fracture of porous metal material structure had been avoided, product structure intensity is improved, further through setting multiple rows of on middle part
The through hole being interspersed, reduces the elastic modelling quantity of product, makes its elastic modelling quantity consistent with the elastic modelling quantity of centrum or close to (power
Learn bionical), it is to avoid because both elastic modelling quantity gaps are excessive, the later stage produces stress shielding, cause bone information, bone deterioration and on
The problems such as hypocentrum abnormal motion or regression, and realize bone tissue and grow into inside it, reach good Integrated implant, high intensity
With reference to, it is to avoid loosen；And by the way that adjacent two row in the middle part of the through hole of multi-row staggered distribution is mutually tied with clamping hole
Close insertion to set, also impart the certain toughness of fusion device main body, make its not only tough and tensile but also high resilience, be conducive to bearing outer masterpiece
With.In addition, the setting in clamping hole has been more convenient clamping and installation during operation is carried out.
(2) upper and lower part of its fusion device main body is preferred to use multistage porous metal material and is made, its biocompatibility
It is good, biological tissue can be guided uniformly to grow into an orderly manner, later stage and vertebral bone tissue fusion, good stability up and down；This kind of multistage is more
Mesoporous metal material, because the pore size size of same one-level vestibule is high in a specific dimensions scope concentration degree, meets it
The special requirement of a specific dimensions vestibule are needed, for example, certain grade of vestibule can design specific dimensions to meet certain specific dimensions cell
Adhesion, live away from home requirement etc.；The multistage porous metal material realizes the three-dimensional insertion of vestibule, including every grade of hole respective three
Insertion is tieed up, holes at different levels also three-dimensional insertion each other mutually, connectivity is good, can fully meet infiltration, the transmission of the materials such as tissue fluid, real
The discharge of existing protein degradation products and metabolism product；And its hole at different levels is uniformly distributed, also specify that it is in small list
The yardstick of position level volume, which gets off, measures the pore size distribution uniformity of multistage porous metal material, and such multistage porous metal material is
High uniformity, so as to ensure that the overall uniformity consistency of its various performance, make its performance uniform and stable, fully meet material
The functional requirement of material, therefore the real bio-regeneration function of product is imparted, make its usage cycles longer, post-operative fusion effect is more
It is good.
Brief description of the drawings
Fig. 1 is the side isometric view of bionical Invasive lumbar fusion device described in embodiment 1 and 3.
Fig. 2 is the front view of bionical Invasive lumbar fusion device described in Fig. 1.
Fig. 3 is the right view of bionical Invasive lumbar fusion device described in Fig. 1.
Fig. 4 is the Section A-A figure of bionical Invasive lumbar fusion device described in Fig. 1.
Fig. 5 is multistage porous material schematic diagram in the present invention, and (a) is front view, and (b) is left view, and (c) is top view.
Fig. 6 is Fig. 5 part A enlarged drawings.
Fig. 7 is the section B-B figure in Fig. 6.
Embodiment
The embodiment to the present invention is explained below in conjunction with the accompanying drawings, and embodiment is using technical solution of the present invention before
Carry, give detailed embodiment and specific operating process, but protection scope of the present invention is not limited only to following implementations
Mode.
Embodiment 1
As shown in Figure of description 1-4, a kind of bionical Invasive lumbar fusion device, including fusion device main body；Its fusion device main body point
For 7 three layers of top 5, middle part 6 and bottom；The upper surface on top 5 and the lower surface of bottom 7 are convexity arc surface；Two of middle part 6
Opposite flank is provided with the through hole 8 of multi-row staggered distribution, and adjacent with being provided with the side of through hole 8 on middle part 6 two other is relative
Side on, be provided with two clamping holes 9, and adjacent two row of the clamping hole 9 with the middle part of through hole 8 positioned at multi-row staggered distribution
Through hole 9 is mutually communicated；Top 5 and bottom 7 are made by porous tantalum material, and its average pore size is 400~1000 μm, and porosity is
60~80%；The middle part 6 of its fusion device main body is made of fine and close medical metal material titanium alloy, and passes through electron beam melting,
Realize and the top 5 of fusion device main body and being fixedly connected for bottom 7 respectively.
Embodiment 2
A kind of bionical Invasive lumbar fusion device, its structure is identical with the structure of bionical Invasive lumbar fusion device described in embodiment 1, secondly
The top 5 and bottom 7 that differ only in bionical Invasive lumbar fusion device in this example of person is made by multistage porous metal material；Its
In, as illustrated in figs. 5-7, wherein 1 is one-level vestibule, 2 be the cavity wall of one-level vestibule to multistage porous metal material；One-level vestibule 1
Cavity wall 2 is constituted by smaller second hole chamber 3 and around the cavity wall 4 of second hole chamber 3；With reference to the enlarged drawing and section B-B to cavity wall 2
Figure understands that second hole chamber 3 is three-dimensional insertion；By that analogy, the cavity wall 4 of second hole chamber 3 is by the three-level smaller than second hole chamber 3
Vestibule and the cavity wall composition around three-level vestibule, this three-level vestibule is also three-dimensional insertion；Thus, three-level hole is formd,
The also three-dimensional insertion each other of this three-level hole；The arrangement of the cavity wall of three-level vestibule and three-level vestibule, with one-level hole and one-level vestibule
Cavity wall arrangement it is identical, that is, make it that the quantity in one-level hole, second hole and three-level hole accounts for this grade of vestibule sum and reached
100%, that is, make it that the pore size size of same level vestibule is high in a specific dimensions scope concentration degree.
In this example, multistage porous metal material is specially porous tantalum, with three-level hole, wherein, it is uniformly distributed, is mutually communicated
First order vestibule cavity wall on have in the second level vestibule for being uniformly distributed, being mutually communicated, the cavity wall of second level vestibule and have uniform
The third level vestibule be distributed, being mutually communicated；And vestibules at different levels also insertion each other each other, described insertion is three-dimensional insertion；Often
Level porous material is from being a continuous structure body, maximum external boundary and the space boundary of whole material body per one-level porous material
Quite, and every grade of porous material has physical and chemical performance alone.Its total effective drainage porosity is 82%, and first order hole average pore size is
510 μm, there is the second level hole of the insertion of 35 μm of average pore size in the cavity wall in first order hole, have flat in the cavity wall in second level hole
The third level hole of equal aperture 720nm insertions.
Method is machined into the multistage porous metal material to take up an official post the identical size that takes 9 1mm × 1mm × 1mm
Said three-dimensional body, its quality is tested with plum Teller-support benefit XP26 Microbalance balances, as a result as shown in table 1, wherein, relatively
It is expressed as a percentage in the absolute value of the bias of average value, its value is average relative to the absolute value of the bias divided by quality of average value
Value, as shown in Table 1, its mass deviation is not more than 4%, it can be seen that, its each vestibule is any on the multistage porous metal material
It is in uniform distribution under cubic millimeter level volume.
Table 1
| Piece number | Quality (mg) | Relative to the absolute value of the bias (%) of average value |
| 1 | 3.283 | 1.50% |
| 2 | 3.293 | 1.20% |
| 3 | 3.243 | 2.70% |
| 4 | 3.266 | 2.01% |
| 5 | 3.286 | 1.41% |
| 6 | 3.446 | 3.39% |
| 7 | 3.409 | 2.28% |
| 8 | 3.396 | 1.89% |
| 9 | 3.379 | 1.38% |
| Mass average value | 3.333 |
The preparation method of multistage porous metal material in the present embodiment is：
(1) material prepares
The polystyrene sphere that particle diameter is 900 ± 30nm is chosen, the colloid template to form three-dimensional order arrangement is assembled,
Tantalum nanocrystal solution is prepared, tantalum nanocrystal solution is introduced into the three-dimensional colloid template that polystyrene sphere is made, by three-dimensional glue
The mixture of body template/tantalum nanocrystal solution is dried, and is then broken for the particle that particle diameter is 5 μm；
(2) starch for taking particle diameter to be 900 ± 30nm, mixes with distilled water according to part by weight 1: 40, starch solution is made,
Slurry is made according to part by weight 12: 1: 8 for 35 μm of ethyl cellulose and starch solution in above-mentioned particle, particle diameter, equably
It is impregnated on the polyester form that aperture is 600 ± 20 μm；
(3) polyester form after dipping is sintered in vacuum or protective atmosphere, carried out according still further to tantalum technique conventional follow-up
Processing, is made the porous tantalum with three-level hole.
According to GBT/7314-2005《Metal material room temperature compression test method》Measure multistage porous metals in the present embodiment
The compressive strength of material is 32MPa, and elastic modelling quantity is 1.05GPa, with the elastic modelling quantity of human body cancellous bone closely.
This kind of porous tantalum, every grade of porous material has properity alone, for example, every grade of porous material has alone
Vestibule size, compression strength, elastic modelling quantity etc., so as to make its vestibule at different levels meet different functional requirements respectively, it makees
For biological regrown material, first order vestibule size is used to meet the demand that the vital tissues such as blood vessel are grown into；Second level vestibule is used for
Various kinds of cell is lived away from home；Third level vestibule is used to meet the sticking of cell, differentiation demand, and particularly, its hierarchical porous structure makes
The elastic modelling quantity of its cavity wall is different from the elastic modelling quantity of raw material in itself, and is reduction of the elastic modelling quantity of cavity wall, third level vestibule
Presence make it that when material stress the cell being lodged in the vestibule cavity wall of the second level really can perceive stress and promote cell point
Split, be that cell division creates basic condition, it is to avoid stress shielding；Moreover, the connectivity of vestibule is good, the respective phase in holes at different levels
Mutual insertion and hole at different levels also insertion each other each other, can fully meet infiltration, the transmission of tissue fluid, realize protein degradation products
And the discharge of metabolism product, therefore it imparts the real bio-regeneration function of product, makes its usage cycles longer, it is postoperative
Syncretizing effect is more preferably.
Embodiment 3
As shown in Figure of description 1-4, a kind of bionical Invasive lumbar fusion device, including fusion device main body；Its fusion device main body point
For 7 three layers of top 5, middle part 6 and bottom；The upper surface on top 5 and the lower surface of bottom 7 are convexity arc surface；Two of middle part 6
Opposite flank is provided with the through hole 8 of multi-row staggered distribution, and adjacent with being provided with the side of through hole 8 on middle part 6 two other is relative
Side on, be provided with two clamping holes 9, and adjacent two row of the clamping hole 9 with the middle part of through hole 8 positioned at multi-row staggered distribution
Through hole 9 is mutually communicated；Top 5 and bottom 7 are made by multistage porous metal material, and the middle part 6 of its fusion device main body is using cause
Close medical metal material titanium alloy is made, and passes through electron beam melting, and top 5 and bottom 7 with fusion device main body are realized respectively
Be fixedly connected.
Wherein, as illustrated in figs. 5-7, wherein 1 is one-level vestibule, 2 be the cavity wall of one-level vestibule to multistage porous metal material；One
The cavity wall 2 of level vestibule 1 is constituted by smaller second hole chamber 3 and around the cavity wall 4 of second hole chamber 3；With reference to the enlarged drawing to cavity wall 2
Understand that second hole chamber 3 is three-dimensional insertion with section B-B figure；By that analogy, the cavity wall 4 of second hole chamber 3 is by than second hole chamber 3
Smaller three-level vestibule and the cavity wall composition around three-level vestibule, this three-level vestibule is also three-dimensional insertion；Thus, foring
Three-level hole, the also three-dimensional insertion each other of this three-level hole；The arrangement of the cavity wall of three-level vestibule and three-level vestibule, with one-level hole and
The arrangement of the cavity wall of one-level vestibule is identical, that is, make it that the quantity in one-level hole, second hole and three-level hole accounts for this grade of vestibule sum
100% is reached, that is, make it that the pore size size of same level vestibule is high in a specific dimensions scope concentration degree.
In this example, multistage porous metal material is specially POROUS TITANIUM, with three-level hole, wherein, it is uniformly distributed, is mutually communicated
First order vestibule cavity wall on have in the second level vestibule for being uniformly distributed, being mutually communicated, the cavity wall of second level vestibule and have uniform
The third level vestibule be distributed, being mutually communicated；And vestibules at different levels also insertion each other each other, described insertion is three-dimensional insertion；Often
Level porous material is from being a continuous structure body, maximum external boundary and the space boundary of whole material body per one-level porous material
Quite, and every grade of porous material has physical and chemical performance alone.
Using section method of direct observation, a plane Electronic Speculum peephole is respectively prepared in material sample three-dimensional respectively,
Digital processing is carried out to image, three face average values are taken, observed result shows：First order vestibule aperture is 150 μm~360 μm,
Second level vestibule aperture is 30 μm~70 μm, and third level vestibule aperture is 200nm~600nm；Wherein, in first order vestibule, 270
± 30 μm of vestibule is accounted in 87%, second level vestibule, and 50 ± 10 μm of vestibule is accounted in 85%, third level vestibule, 450 ± 60nm's
Vestibule accounts for 82%.Respectively with the gross area in holes at different levels compared with the sample gross area, the porosity for obtaining first order vestibule is 64%, the
The porosity of second hole chamber is 10%, and the porosity of third level vestibule is 6%.
Method is machined into the multistage porous metal material to take up an official post the identical size that takes 9 1mm × 1mm × 1mm
Said three-dimensional body, its quality is tested with plum Teller-support benefit XP26Microbalance balances, as a result as shown in table 2, wherein, relatively
It is expressed as a percentage in the absolute value of the bias of average value, its value is average relative to the absolute value of the bias divided by quality of average value
Value, as shown in Table 2, its mass deviation is not more than 4%, it can be seen that, its each vestibule is any on the multistage porous metal material
It is in uniform distribution under cubic millimeter level volume.
Table 2
| Piece number | Quality (mg) | Relative to the absolute value of the bias (%) of average value |
| 1 | 1.156 | 1.37% |
| 2 | 1.135 | 3.16% |
| 3 | 1.151 | 1.79% |
| 4 | 1.157 | 1.28% |
| 5 | 1.146 | 2.22% |
| 6 | 1.217 | 3.84% |
| 7 | 1.197 | 2.13% |
| 8 | 1.191 | 1.62% |
| 9 | 1.202 | 2.56% |
| Mass average value | 1.172 |
The preparation method of multistage porous metal material in the present embodiment is：
(1) material prepares
It is raw material for 1-10 μm of titanium valve to use particle diameter, and particle diameter is 300nm-700nm starch as porous material to be made
Minimum one-level vestibule pore creating material, the stearic acid for being 300nm-700nm with particle diameter is as adhesive, according to titanium valve：Starch：Firmly
Resin acid：Distilled water is configured to slurry at 3: 1: 1: 10 by volume.
Use aperture for 500-800 μm of polyester form, uniformly filling wherein, is formed with foam impregnation method by the slurry
Base substrate and drying, then crush the hybrid particles containing raw material, pore creating material and polyester form for obtaining that particle is 40-80 μm.
(2) will equably it be filled after hybrid particles, ethyl cellulose 3: the 1 uniform mixing by volume that particle diameter is 40-80 μm
Enter in the polyester form of a diameter of 200-400 μm of rib, aperture for 340-440 μm of three-dimensional insertion, be then put into polyester form
Closed mold is pressed into dense green.
(3) by dense green vacuum-sintering；Base substrate after sintering carries out conventional subsequent heat treatment according to titanium technique and obtained
POROUS TITANIUM with three-level hole.
According to GBT/7314-2005《Metal material room temperature compression test method》Measure multistage porous metals in the present embodiment
The elastic modelling quantity of material and the elastic modelling quantity of human body cancellous bone are closely.
Similar to embodiment 2, this kind of material is particularly suitable to be used as bone implant material, imparts the real bio-regeneration of product
Function.
Claims (7)
1. a kind of bionical Invasive lumbar fusion device, including fusion device main body, it is characterised in that：The fusion device main body is divided into top（5）、
Middle part（6）And bottom（7）Three layers；The top（5）Upper surface and the bottom（7）Lower surface be convexity arc surface；Institute
State middle part（6）Two opposite flanks be provided with multi-row staggered distribution through hole（8）；The top（5）With the bottom（7）
It is made up of porous metal material.
2. bionical Invasive lumbar fusion device as claimed in claim 1, it is characterised in that：The middle part（6）Above with being provided with through hole（8）Side
On two other adjacent relative side of face, clamping hole is provided with（9）.
3. bionical Invasive lumbar fusion device as claimed in claim 1 or 2, it is characterised in that：The clamping hole（9）With positioned at described multiple rows of
The through hole being interspersed（8）Adjacent two exhausting hole at middle part（8）It is mutually communicated.
4. bionical Invasive lumbar fusion device as claimed in claim 3, it is characterised in that：The clamping hole（9）For two.
5. the bionical Invasive lumbar fusion device as described in claim 1-4 is any, it is characterised in that：The porous metal material is using multistage
Porous metal material, with three-level hole, its material body is the vestibule being classified with material pore size, and around forming hole
The cavity wall of chamber is constituted；Wherein, have in the cavity wall for the first order vestibule be uniformly distributed, being mutually communicated and to be uniformly distributed, be mutually communicated
There is the third level vestibule for being uniformly distributed, being mutually communicated in second level vestibule, the cavity wall of second level vestibule；And vestibule at different levels is mutual
Also insertion each other, described insertion is three-dimensional insertion；Every grade of porous material is from being a continuous structure body, per one-level porous material
Maximum external boundary is suitable with the space boundary of whole material body, and every grade of porous material has physical and chemical performance alone.
6. bionical Invasive lumbar fusion device as claimed in claim 5, it is characterised in that：The multistage porous metal material, with one-level hole
The quantity in the hole of one specific dimensions scope of chamber accounts for more than the 80% of this grade of hole sum.
7. the bionical Invasive lumbar fusion device as described in claim 5 or 6, it is characterised in that：The multistage porous metal material, its each hole
Chamber under arbitrary unit level volume is in uniform distribution on multistage porous metal material, wherein, unit level volume refers to cube
Grade or more subsection level volume；Vestibule refers to take up an official post the volume that takes not in the multistage porous metal material in uniform distribution
Each said three-dimensional body of formed objects more than 1 cubic millimeter, their quality is substantially suitable；Quality quite refers to many in multistage substantially
Mesoporous metal material take up an official post the multiple volumes taken be not more than 1 cubic millimeter formed objects said three-dimensional body, its quality is claimed respectively, is obtained
The average value of their quality, and any three-dimensional weight is not more than three-dimensional weight relative to the absolute value of the bias of mass average value
The 4% of average value.
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| CN110368147A (en) * | 2019-08-05 | 2019-10-25 | 北京爱康宜诚医疗器材有限公司 | Invasive lumbar fusion device and preparation method thereof |
| CN110946682A (en) * | 2019-12-16 | 2020-04-03 | 淮阴工学院 | Artificial cervical intervertebral disc prosthesis convenient for neck movement |
| CN113143550A (en) * | 2021-05-20 | 2021-07-23 | 四川大学 | Fusion cage with multi-level bionic active fusion function and preparation method thereof |
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Application publication date: 20170714 |