CN106943214A - A kind of light-duty Invasive lumbar fusion device - Google Patents
A kind of light-duty Invasive lumbar fusion device Download PDFInfo
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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
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/04—Metals or alloys
- A61L27/047—Other specific metals or alloys not covered by A61L27/042 - A61L27/045 or A61L27/06
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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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/04—Metals or alloys
- A61L27/06—Titanium or titanium alloys
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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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/56—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
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
- A61F2002/30011—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in porosity
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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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Abstract
The present invention relates to a kind of light-duty 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）With the bottom（7）It is made by porous metal material；The middle part（6）For engraved structure, in four sides only two relative entities sideways, and middle part（6）Center at be provided with a roller gear（8）；The roller gear（8）Upper and lower ends respectively with the top（5）Lower surface and the bottom（7）Upper surface directly contact, and the roller gear（8）Inside be communicated with the top（5）With the bottom（7）Cavity（10）.Simple structure of the present invention, lightweight, elastic modelling quantity are suitable, can be readily adjusted its own position and direction in intervertebral, stable connection.
Description
Technical field
The present invention relates to intervertebral fixation device, more particularly to a kind of light-duty Invasive lumbar fusion device.
Background technology
For caused by backbone regression between disc herniation and centrum it is unstable, clinically frequently with implantable artificial intervertebral fusion
The modus operandi of device, to improve the effect of intervertebral fusion.Although this modus operandi can obtain more satisfied short term efficacy,
It is that the Invasive lumbar fusion device generally used at present still suffers from following defect：Product is heavy, complex structural designs；Product elastic modelling quantity compared with
Height, excessive with centrum elastic modelling quantity gap, the later stage produces stress shielding, causes bone information, bone deterioration and upper hypocentrum to be transported extremely
Dynamic or regression；Position and direction of the fusion device in intervertebral can not be adjusted after implantation easily, sending down the fishbone on fusion device are easily caused whole
Plate stress distribution is uneven, and connection is unstable.In addition, existing Invasive lumbar fusion device product is after the implantation, biological tissue of human body can not be equal
It is even, grow into its inside configuration in an orderly manner, cause it not reach good Integrated implant, bond strength low, poor biocompatibility, also without
Method meets blood, the infiltration of tissue fluid, transmission, realizes the discharge of protein degradation products and metabolism product, causes it certainly
Body can not realize bio-regeneration.
At present, the Invasive lumbar fusion device set in the prior art using loose structure, is acted on by induced osteogenesis so that
Bone tissue is grown into, to increase biocompatibility and bond strength, and by controlling the parameters such as aperture and porosity come regulation elasticity
Modulus, to avoid producing the report such as stress shielding, but existing porous material is simple in construction, mostly single distribution hole, no
A variety of functional requirements can be met, such as its pore size and connectedness is difficult to control to, this will prevent material from fully, be accurately finished
Required function.Just because of this, new multistage Porous materials, because it has the advantage in holes at different levels simultaneously, have single Porous materials concurrently again
This unique performance of not available advantage, it has also become the focus studied at present.
As the multilevel hole material of biomimetic artificial bone, need material uniform in itself in the application, i.e. pore size, point in hole
Cloth is uniform so that performance uniformity, but in fact, existing multilevel hole material does not reach the requirement, the arrangement of its multi-stage porous
Random big, pore size size and connectedness are uncontrollable, and distribution of pores is also uneven, there is internal flaw, it is impossible to meet and make
For the functional requirement of Bionic bone dummy.For example, in spite of material call oneself and reached higher uniformity, but its uniformity is still
It is the uniformity under large volume yardstick, if carrying out measurement comparison with small size yardstick, such as takes up an official post in material and take polylith volume not
Said three-dimensional body more than one cubic centimetre, surveys its quality respectively, and its degree of irregularity difference is still very big, therefore causes multi-stage porous
The various performances of material such as intensity, elastic modelling quantity etc. it is uneven, 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 light-duty Invasive lumbar fusion device, its simple structure, lightweight, elastic modelling quantity is fitted
Preferably, its own position and direction in intervertebral can be readily adjusted.
Objects of the present invention are achieved through the following technical solutions：
A kind of light-duty 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 top and the bottom are made by porous metal material；The middle part is engraved structure, four
Only have two relative entities sideways in side, and a roller gear is provided with the center at middle part；The roller gear
Upper and lower ends are directly contacted with the lower surface on the top and the upper surface of the bottom respectively, and the inside of the roller gear
It is communicated with the cavity of the top and the bottom.
As further optimization, the lower surface of the upper surface on above-mentioned top and above-mentioned bottom is convexity arc surface.
Optimize as further, on two relative entity sides at above-mentioned middle part, be provided with clamping hole.The clamping
Two clamping holes are equipped with Kong Gongwei tetra-, each entity side.
As further optimization, above-mentioned cavity is set to the cylinder concentric with above-mentioned roller gear, and the volume of cavity
For 1st/1st to two/3rd of roller gear volume.
As further optimizing, in order that obtaining the light-duty 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, the bond strength between both enhancings, and meet blood, group
Infiltration, the transmission of liquid are knitted, the discharge of protein degradation products and metabolism product is realized, it is just truly showed bio-regeneration,
Above-mentioned porous metal material is preferred to use multistage porous metal material, with three-level hole, and its material body is big with material aperture
The small vestibule being classified, and constituted around the cavity wall for forming vestibule；Wherein, the first order vestibule be uniformly distributed, being mutually communicated
Cavity wall on have and be uniformly distributed in the second level vestibule for being uniformly distributed, being mutually communicated, the cavity wall of second level vestibule, be mutually communicated
Third level vestibule；And vestibules at different levels also insertion each other each other, described insertion is three-dimensional insertion；Every grade of porous material is from being
One continuous structure body, the maximum external boundary per one-level porous material is suitable with the space boundary of whole material body, and every grade many
Porous materials have physical and chemical performance alone.Such structure may be such that the physical and chemical performances of porous materials at different levels difference, in phase
To having different physical and chemical performances in the fixed whole space of material, many unique function demands are met.
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 85% 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
High concentration is enclosed, the special requirement for making it meet the specific dimensions vestibule of needs one.
More specifically, above-mentioned multistage porous metal material, its each vestibule is any cube on multistage porous metal material
It is in uniform distribution under grade or more subsection level volume；Vestibule refers in the multistage porous metals material in uniform distribution
Material take up an official post the volume that takes be not more than 1 cubic millimeter formed objects each said three-dimensional body, their quality is substantially suitable；Quality is basic
Quite refer to multistage porous metal material take up an official post multiple volumes for taking be not more than 1 cubic millimeter formed objects said three-dimensional body,
Claim its quality respectively, obtain the average value of their quality, and any three-dimensional weight is absolute relative to the deviation of mass average value
Value is not more than the 4% of said three-dimensional body mass average value.
Above-mentioned multistage porous metal material, can be the metal material of single-element, or alloy material.For example, can
From titanium, tantalum, titanium alloy etc..
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 light-duty Invasive lumbar fusion device, its simple structure, lightweight, fusion device main body middle part are adopted
Designed with hollow out, reduce the elastic modelling quantity of product, make its elastic modelling quantity consistent with the elastic modelling quantity of centrum or close to (mechanics is imitated
It is raw), it is to avoid because both elastic modelling quantity gaps are excessive, later stage generation stress shielding causes bone information, bone deterioration and upper hypocentrum
The problems such as abnormal motion or regression；And the middle part of its fusion device main body uses compact metal material to connect top and the bottom, keeps away
Exempt from the brittle fracture of porous metal material structure, improve product structure intensity；Middle part is being stirred just by instrument after the implantation
The roller gear that center is set, realizes regulation fusion device and is in suitable position and direction in intervertebral easily, it is to avoid
Sending down the fishbone soleplate stress distribution is uneven on fusion device, the problems such as connection is unstable.In addition, the upper and lower part of its fusion device main body is adopted
Use convexity arc surface structure, it is not easy to produce slip, improve the stability after implantation；Porous metal material body structure surface can be carried
For larger frictional force, stability further enhancing；The setting in clamping hole facilitates during operation is carried out and clamps and install this production
Product.
(2) upper and lower part of its fusion device main body is preferred to use multistage porous metal material and is made, its bio-compatible
Property 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；And it is justified
Cavity inside stud wheel, has connected upper and lower part, has both realized the two-way flow of material between upper and lower part, has imparted again
The another space that biological tissue grows into, the later stage can realize that the biological tissue grown into is connected as a single entity, and further increase its biofacies
Capacitive and stability.In its multistage porous metal material, because the pore size size of same one-level vestibule is in a specific dimensions model
High concentration is enclosed, the special requirement for alloing it to meet the specific dimensions vestibule of needs one, for example, certain grade of vestibule can design specific chi
Very little adhesion to meet certain specific dimensions cell, requirement etc. of living away from home；The multistage porous metal material realizes the three-dimensional of vestibule
Insertion, including each three-dimensional insertion of every grade of hole, holes at different levels also three-dimensional insertion each other mutually, connectivity are good, can fully meet group
Infiltration, the transmission of the materials such as liquid are knitted, the discharge of protein degradation products and metabolism product is realized；And its hole at different levels is uniform
Distribution, also specify that it is to measure pore size distribution uniformity, such multistage porous metals under the yardstick of subsection level volume
Material is high uniformity, so as to ensure that the overall uniformity consistency of its various performance, makes its performance uniform and stable, fully full
The foot functional requirement of material, therefore impart the real bio-regeneration function of product, make its usage cycles longer, post-operative fusion
It is better.
Brief description of the drawings
Fig. 1 is the structural representation of light-duty Invasive lumbar fusion device described in embodiment 1 and 3.
Fig. 2 is the left view of light-duty Invasive lumbar fusion device described in Fig. 1.
Fig. 3 is the Section A-A figure of light-duty Invasive lumbar fusion device described in Fig. 1.
Fig. 4 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. 5 is Fig. 4 part A enlarged drawings.
Fig. 6 is the section B-B figure in Fig. 5.
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 1-3, a kind of light-duty Invasive lumbar fusion device, including fusion device main body；Fusion device main body is divided into
7 three layers of top 5, middle part 6 and bottom；Top 5 and bottom 7 are made by porous tantalum material, and its average pore size is 600~800 μm,
Porosity is 75~80%；The upper surface on top 5 and the lower surface of bottom 7 are convexity arc surface；Its middle part 6 is engraved structure,
Only have two relative entities sideways in four sides, and a roller gear 8 is provided with the center at middle part 6；The two of middle part 6
On individual relative entity side, two clamping holes 9 are equipped with；The upper and lower ends of roller gear 8 respectively with the lower surface on top 5 and
The upper surface of bottom 7 is directly contacted, and the inside of roller gear 8 is communicated with the cavity 10 of top 5 and bottom 7, the cavity 10
The cylinder concentric with roller gear 8 is set to, and the volume of cavity 10 is 1/2nd of the volume of roller gear 8；It is merged
The middle part 6 of device main body is made of fine and close medical metal material titanium alloy, and passes through electron beam melting, is realized respectively and fusion device
The top 5 of main body and being fixedly connected for bottom 7.
Embodiment 2
A kind of light-duty Invasive lumbar fusion device, its structure is identical with the structure of light-duty Invasive lumbar fusion device described in embodiment 1, secondly
The top 5 and bottom 7 that differ only in light-duty Invasive lumbar fusion device in this example of person is made by multistage porous metal material；Its
In, as Figure 4-Figure 6,1 is one-level vestibule to multistage porous metal material in its multistage porous metal material, and 2 be one-level vestibule
Cavity wall；The cavity wall 2 of one-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 cavity wall 2
Enlarged drawing and section B-B figure understand, second hole chamber 3 is three-dimensional insertion；By that analogy, the cavity wall 4 of second hole chamber 3 is by than two
The smaller three-level vestibule of level vestibule 3 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 is identical with the arrangement of the cavity wall of one-level vestibule, that is, make it that the quantity in one-level hole, second hole and three-level hole accounts for this level
Vestibule sum reaches 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 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 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 | 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.
This kind of porous titanium material, its every grade porous material has properity alone, for example, every grade of porous material tool
There are vestibule size alone, compression strength, elastic modelling quantity etc., so as to make its vestibule at different levels meet different function need respectively
Ask, it can be as bio-regeneration material, and first order vestibule size is used to meet the demand that the vital tissues such as blood vessel are grown into；The second level
Vestibule is used for living away from home for various kinds of cell；Third level vestibule is used to meet the sticking of cell, differentiation demand, and particularly, it is multistage
Pore structure makes the elastic modelling quantity of its cavity wall be different from the elastic modelling quantity of raw material in itself, and is reduction of the elastic modelling quantity of cavity wall, the
The presence of three-level vestibule 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
Enter cell division, be that cell division creates basic condition, it is to avoid stress shielding；Moreover, the connectivity of vestibule is good, Ge Jikong
Each it is mutually communicated and hole at different levels also insertion each other each other, can fully meets infiltration, the transmission of tissue fluid, realize protein
The discharge of catabolite and metabolism product, therefore it is a kind of real bio-regeneration material.
Embodiment 3
As shown in Figure of description 1-4, a kind of light-duty Invasive lumbar fusion device, including fusion device main body；Fusion device main body is divided into
Top 5, middle part 6 and bottom 7；Top 5 and bottom 7 are made by multistage porous metal material, and the upper surface and bottom on top 5
7 lower surface is convexity arc surface；Its middle part 6 is engraved structure, in four sides only two relative entities sideways, and in
A roller gear 8 is provided with the center in portion 6；On two relative entity sides at middle part 6, two clamping holes 9 are equipped with；
The upper and lower ends of roller gear 8 are directly contacted with the lower surface on top 5 and the upper surface of bottom 7 respectively, and roller gear 8 is interior
Portion is communicated with the cavity 10 of top 5 and bottom 7, and the cavity 10 is set to the cylinder concentric with roller gear 8, and cavity 10
Volume be the volume of roller gear 8 1/2nd；The middle part 6 of its fusion device main body is using fine and close medical metal material titanium alloy
It is made, and passes through electron beam melting, realizes and the top 5 of fusion device main body and being fixedly connected for bottom 7 respectively.
Wherein, as Figure 4-Figure 6,1 is one-level vestibule to multistage porous metal material in its multistage porous metal material, and 2 are
The cavity wall of one-level vestibule；The cavity wall 2 of one-level vestibule 1 is constituted by smaller second hole chamber 3 and around the cavity wall 4 of second hole chamber 3；Knot
Close and second hole chamber 3, which is three-dimensional insertion, to be understood to the enlarged drawing and section B-B figure of cavity wall 2；By that analogy, the chamber of second hole chamber 3
Wall 4 is constituted by the three-level vestibule smaller than second hole chamber 3 and around the cavity wall of three-level vestibule, and this three-level vestibule is also three-dimensional insertion
's；Thus, three-level hole is formd, the also three-dimensional insertion each other of this three-level hole；The row of the cavity wall of three-level vestibule and three-level vestibule
Cloth structure, it is identical with the arrangement in one-level hole and the cavity wall of one-level vestibule, that is, cause the number in one-level hole, second hole and three-level hole
Amount accounts for this grade of vestibule sum and reaches 100%, that is, causes the pore size size of same level vestibule in a specific dimensions range set
Degree is high.
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 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 | 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.
Similar to embodiment 2, this kind of material is particularly suitable to be used as bone implant material, is a kind of real bio-regeneration material
Material.
Claims (10)
1. a kind of light-duty 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）With the bottom（7）It is made by porous metal material；The middle part（6）
For engraved structure, in four sides only two relative entities sideways, and middle part（6）Center at be provided with a Cylinder Gear
Wheel（8）；The roller gear（8）Upper and lower ends respectively with the top（5）Lower surface and the bottom（7）Upper surface
Directly contact, and the roller gear（8）Inside be communicated with the top（5）With the bottom（7）Cavity（10）.
2. light-duty Invasive lumbar fusion device as claimed in claim 1, it is characterised in that：The top（5）Upper surface and the bottom
（7）Lower surface be convexity arc surface.
3. light-duty Invasive lumbar fusion device as claimed in claim 1 or 2, it is characterised in that：The middle part（6）Two relative entities
On side, clamping hole is provided with（9）.
4. light-duty Invasive lumbar fusion device as claimed in claim 1 or 2, it is characterised in that：The middle part（6）Each entity side on
It is equipped with two clamping holes（9）.
5. light-duty Invasive lumbar fusion device as claimed in claim 1 or 2, it is characterised in that：The cavity（10）It is set to and the cylinder
Gear（8）Concentric cylinder, and cavity（10）Volume be roller gear（8）/ to two/3rd of volume.
6. light-duty Invasive lumbar fusion device as claimed in claim 3, it is characterised in that：The cavity（10）It is set to and the roller gear
（8）Concentric cylinder, and cavity（10）Volume be roller gear（8）/ to two/3rd of volume.
7. light-duty Invasive lumbar fusion device as claimed in claim 4, it is characterised in that：The cavity（10）It is set to and the roller gear
（8）Concentric cylinder, and cavity（10）Volume be roller gear（8）/ to two/3rd of volume.
8. the light-duty Invasive lumbar fusion device as described in claim 1-7 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.
9. light-duty Invasive lumbar fusion device as claimed in claim 8, 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 85% of this grade of hole sum.
10. the light-duty Invasive lumbar fusion device as described in claim 8 or 9, it is characterised in that：The multistage porous metal material, its is each
Vestibule is on multistage porous metal material in uniform distribution under any cubic millimeter level or more subsection grade volume；Vestibule is in
Uniform distribution 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
Body is tieed up, their quality is substantially suitable；Quality quite refers to take up an official post multiple volumes for taking not in multistage porous metal material substantially
The said three-dimensional body of formed objects more than 1 cubic millimeter, claims its quality respectively, obtains the average value of their quality, and any three-dimensional
Weight 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.
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| CN201611083349.1A CN106943214A (en) | 2016-11-30 | 2016-11-30 | A kind of light-duty Invasive lumbar fusion device |
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| CN201611083349.1A CN106943214A (en) | 2016-11-30 | 2016-11-30 | A kind of light-duty Invasive lumbar fusion device |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| 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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