CN106943212A - A kind of steady type Invasive lumbar fusion device - Google Patents
A kind of steady type Invasive lumbar fusion device Download PDFInfo
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- CN106943212A CN106943212A CN201611082244.4A CN201611082244A CN106943212A CN 106943212 A CN106943212 A CN 106943212A CN 201611082244 A CN201611082244 A CN 201611082244A CN 106943212 A CN106943212 A CN 106943212A
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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
- A61F2/447—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 substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
-
- 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
-
- 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
-
- 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
-
- 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
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/38—Materials or treatment for tissue regeneration for reconstruction of the spine, vertebrae or intervertebral discs
Abstract
The present invention relates to a kind of steady type Invasive lumbar fusion device.It is divided into top, middle part（7）With three layers of bottom；Its top is along middle part（7）Two strip shape bodies that long side surface direction is spaced apart（5）, two strip shape bodies（5）It is located at middle part respectively（7）Two edges of upper surface, two strip shape bodies（5）Between to grow into groove（6）；The middle part（7）Two relative long side surfaces on be respectively equipped with groove along long side surface directional spreding（8）；Its underpart is along middle part（7）Two strip shape bodies that long side surface direction is spaced apart（9）, two strip shape bodies（9）It is located at middle part respectively（7）Two edges of lower surface, two strip shape bodies（9）Between to grow into groove（10）；The top and the bottom are made by porous metal material, and with the middle part（7）Fixation is integral.Simple structure of the present invention, lightweight, elastic modelling quantity are suitable, and self can be achieved and consolidates.
Description
Technical field
The present invention relates to intervertebral fixation device, more particularly to a kind of steady type Invasive lumbar fusion device.
Background technology
Clinically frequently with the modus operandi of implantable artificial Invasive lumbar fusion device, dashed forward to treat interverbebral disc caused by backbone regression
Go out unstable between centrum.Although this operation can obtain more satisfied curative effect, due to the intervertebral fusion generally used at present
Device still suffers from following defect, therefore greatly limit the effect of intervertebral fusion：Product is heavy, and foreign body sensation is strong after implantation, structure
Design is complicated, relatively complicated in terms of construction；Product elastic modelling quantity is higher, excessive with centrum elastic modelling quantity gap, and the later stage produces
Stress shielding, causes bone information, bone deterioration and upper hypocentrum abnormal motion or regression；Shakiness is connected after implantation needs lock screw
Auxiliary is fixed, and implant can not usually realize that self is consolidated.In addition, existing Invasive lumbar fusion device is after the implantation, human-body biological group
Its inside configuration can not be grown into uniformly, in an orderly manner by knitting, and cause it not reach good Integrated implant, bond strength low, bio-compatible
Property it is poor, can not also meet blood, the infiltration of tissue fluid, transmission, realize the discharge of protein degradation products and metabolism product,
Cause its own can not realize bio-regeneration.
It is steady to realize self although also having in the existing design of part using loose structure is set come so that bone tissue is grown into
Gu, the increase report such as biocompatibility and bond strength, but be due to that its porous material is simple in construction, mostly single distribution hole
Gap, it is impossible to meet a variety of functional requirements, such as its pore size and connectedness are difficult to control to, and this will prevent material from fully, accurately
Ground completes required function.Just because of this, the advantage that new multistage Porous materials had both had holes at different levels because of it, has single hole material concurrently again
Not available advantage this special performance of material, it has also become current study hotspot.
As the multilevel hole material of biomimetic artificial bone, need material uniform in itself in the application, i.e. pore size, distribution is equal
It is even, to cause performance uniformity, but in fact, existing multilevel hole material does not reach the requirement, the arrangement of its multi-stage porous with
Meaning property is big, and pore size size and connectedness are uncontrollable, and distribution of pores is also uneven, there is internal flaw, it is impossible to meet conduct
The functional requirement of Bionic bone dummy.For example, in spite of material call oneself and reached higher uniformity, but its uniformity is still
Uniformity under large volume yardstick, if carrying out measurement comparison with small size yardstick, such as takes up an official post in material and takes polylith volume little
In one cubic centimetre of said three-dimensional body, its quality is surveyed respectively, and its degree of irregularity difference is still very big, therefore causes multi-stage porous material
Material various performances such as intensity, elastic modelling quantity, stress distribution 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 steady type Invasive lumbar fusion device, its simple structure, lightweight, elastic modelling quantity is fitted
Preferably, and can realize self consolidate.
Objects of the present invention are achieved through the following technical solutions：
A kind of steady type Invasive lumbar fusion device, it is characterised in that：It is divided into three layers of upper, middle and lower；The top is
Two strip shape bodies being spaced apart, two strip shape bodies are located between two edges of middle part upper surface, two strip shape bodies respectively
Groove is grown into for two ends insertion；The groove of two ends insertion is respectively arranged with two relative long side surfaces at the middle part；It is described
Bottom is two strip shape bodies being spaced apart, and two strip shape bodies are located at two edges of middle part lower surface, two strips respectively
Between body groove is grown into for two ends insertion；The top and the bottom are made by porous metal material, welded or melting
Deng usual manner, it is connected is integral with the middle part respectively.
As further optimization, the lower end of the upper end of two strip shape bodies on above-mentioned top and two strip shape bodies of above-mentioned bottom
It is disposed as the double wedge being randomly distributed.The lower end of the upper end of top strip shape body and bottom strip shape body is set to bulge-structure, both
Can improve the early stage stability after implantation, and after the implantation the phase grow into top and the bottom respectively by bone tissue grow into groove and bar
Portion in shape body, make it that two strip shape bodies of the upper and lower ends for being similar to jaw structure are tightly combined with growing into body, greatly promotes again
The stability of its connection.
Optimize as further, the groove on above-mentioned two relative long side surfaces in middle part is symmetrical.Pass through its middle part of the setting
As I-shaped so that it had both had the advantages that excellent bending resistance as primary structure member, deadweight further is alleviated again,
It is more convenient easy in terms of construction.
As further optimizing, in order that obtaining the steady type Invasive lumbar fusion device has excellent biocompatibility, make it
After implantation human body, biological tissue is guided uniformly to grow into an orderly manner, the bond strength between both enhancings, and meet blood, tissue
The infiltration of liquid, transmission, realize the discharge of protein degradation products and metabolism product, it is just truly showed bio-regeneration, on
State porous metal material and be preferred to use multistage porous metal material, with three-level hole, its material body is with material pore size
The vestibule being classified, and constituted around the cavity wall for forming vestibule；Wherein, the first order vestibule be uniformly distributed, being mutually communicated
Have to have in the second level vestibule for being uniformly distributed, being mutually communicated, the cavity wall of second level vestibule in cavity wall and be uniformly distributed, 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 one certainly
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 porous
Material has physical and chemical performance alone.Such structure may be such that the physical and chemical performances of porous materials at different levels difference, relative
There is different physical and chemical performances in the whole space of fixed 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..
Above-mentioned middle part is made of fine and close medical metal material, and by routine sides such as laser welding or electron beam meltings
Formula, realizes be fixedly connected with above-mentioned upper and lower part respectively.
The present invention has following beneficial effect：
(1) the invention provides a kind of steady type Invasive lumbar fusion device, its simple structure, lightweight, and it can realize that self is steady
Gu.Wherein, groove and groove are grown into by being set respectively at top, bottom and middle part, significantly reduces dead load, alleviate plant
Foreign body sensation after entering, its top, bottom are made of porous metal material, have both further mitigated deadweight, are provided again larger
Frictional force, enhance implantation after early stage stability；The lower end of the upper end of top strip shape body and bottom strip shape body is set to convex
Structure is played, the early stage stability after implantation is both improved, and the phase grows into the length of top and the bottom by bone tissue respectively after the implantation
Enter inside groove and strip shape body, cause that two strip shape bodies of the upper and lower ends for being similar to jaw structure are tightly combined with growing into body again,
Greatly improve the stability of its connection；Its middle part is set to I-shaped so that it both has excellent bending resistance as primary structure member
The advantages of ability, deadweight further is alleviated again, it is more convenient easy in terms of construction, and combine the strip shape body of top and the bottom point
It is distributed in the upper and lower of central groove so that its top and the bottom is in the effect of endurance, with suitable elastic modelling quantity, it is to avoid its
Elastic modelling quantity and centrum elastic modelling quantity gap are excessive, and the later stage can produce stress shielding, cause bone information, bone deterioration and upper hypocentrum
The problems such as abnormal motion or regression.In addition, its symmetrical configuration, overall uniform force during the effect of endurance.
(2) its fusion device main body middle and upper part and bottom are preferred to use multistage porous metal material and are 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.Its multistage is more
In mesoporous metal material, because the pore size size of same one-level vestibule is concentrated in a specific dimensions extent height, expire it
Foot needs the special requirement of a specific dimensions vestibule, for example, can to design specific dimensions thin to meet certain specific dimensions for certain grade of vestibule
The adhesion of born of the same parents, requirement etc. of living away from home；The multistage porous metal material realizes the three-dimensional insertion of vestibule, including every grade of hole is respective
Three-dimensional insertion, 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,
Realize the discharge of protein degradation products and metabolism product；And its hole at different levels is uniformly distributed, also specify that it is small
The yardstick of unit level volume gets off to measure pore size distribution uniformity, and such multistage porous metal material is high uniformity, so that
The overall uniformity consistency of its various performance is ensure that, makes its performance uniform and stable, fully meets the functional requirement of material, because
This imparts the real bio-regeneration function of product, makes that its usage cycles is longer, and post-operative fusion is better.
Brief description of the drawings
Fig. 1 is the structural representation of steady type Invasive lumbar fusion device described in embodiment 1 and 3.
Fig. 2 is the front view of steady type Invasive lumbar fusion device described in Fig. 1.
Fig. 3 is the top view of steady type Invasive lumbar fusion device described in Fig. 1.
Fig. 4 is the left view of steady type 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 steady type Invasive lumbar fusion device, it is divided into three layers of top, middle part 7 and bottom；
Top is along two strip shape bodies 5 being spaced apart from one end of the long side surface of middle part 7 to the direction of the other end, two strip shape bodies 5
It is located at respectively between two edges of the upper surface of middle part 7, two strip shape bodies 5 and grows into groove 6 for two ends insertion；The two of middle part 7
The groove along the two ends insertion from directional spreding of the one end of long side surface to the other end is respectively equipped with individual relative long side surface
8, and two grooves 8 at middle part 7 are symmetrical；Bottom is to be spaced apart along from one end of the long side surface of middle part 7 to the direction of the other end
Two strip shape bodies 9, two strip shape bodies 9 are located at two edges of the lower surface of middle part 7 respectively, are two between two strip shape bodies 9
That holds insertion grows into groove 10；The upper end of two strip shape bodies 5 on top and the lower end of two strip shape bodies 9 of bottom are disposed as not advising
The double wedge being then distributed；Upper and lower part is made by porous tantalum material, its average pore size be 650~750 μm, porosity be 75~
85%, and through electron beam melting respectively with to use the middle part 7 that fine and close medical metal material titanium alloy is made to be connected whole for one
Body.
Embodiment 2
A kind of steady type Invasive lumbar fusion device, its structure is identical with the structure of steady type Invasive lumbar fusion device described in embodiment 1,
The upper and lower part for differing only in steady type Invasive lumbar fusion device in this example both it is made by multistage porous metal material；
Wherein, as illustrated in figs. 5-7,1 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 understands that second hole chamber 3 is three-dimensional insertion；By that analogy, the cavity wall 4 of second hole chamber 3 by than
The smaller three-level vestibule of second hole chamber 3 and the cavity wall composition around three-level vestibule, this three-level vestibule is also three-dimensional insertion；Such as
This, that is, form three-level hole, the also three-dimensional insertion each other of this three-level hole；The arrangement knot of the cavity wall of three-level vestibule and three-level vestibule
Structure, it is identical with the arrangement in one-level hole and the cavity wall of one-level vestibule, that is, make it that the quantity in one-level hole, second hole and three-level hole is accounted for
This grade of 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 XP26Microbalance 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, particle diameter for 300nm~700nm starch as waiting to make porous material
The pore creating material of the minimum one-level vestibule of material, the stearic acid for being 300nm~700nm with particle diameter is as adhesive, according to titanium valve: starch
: stearic acid: distilled water is configured to slurry at 3: 1: 1: 10 by volume.
Use aperture for 500~800 μm of polyester form, the slurry is uniformly filled wherein with foam impregnation method, shape
Into base substrate and drying, the hybrid particles containing raw material, pore creating material and polyester form for obtaining that particle is 40~80 μm are then crushed.
(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, then put polyester form
Enter closed mold and be 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 steady type Invasive lumbar fusion device, it is divided into three layers of top, middle part 7 and bottom；
Top is along two strip shape bodies 5 being spaced apart from one end of the long side surface of middle part 7 to the direction of the other end, two strip shape bodies 5
It is located at respectively between two edges of the upper surface of middle part 7, two strip shape bodies 5 and grows into groove 6 for two ends insertion；The two of middle part 7
The groove along the two ends insertion from directional spreding of the one end of long side surface to the other end is respectively equipped with individual relative long side surface
8, and two grooves 8 at middle part 7 are symmetrical；Bottom is to be spaced apart along from one end of the long side surface of middle part 7 to the direction of the other end
Two strip shape bodies 9, two strip shape bodies 9 are located at two edges of the lower surface of middle part 7 respectively, are two between two strip shape bodies 9
That holds insertion grows into groove 10；The upper end of two strip shape bodies 5 on top and the lower end of two strip shape bodies 9 of bottom are disposed as not advising
The double wedge being then distributed；Upper and lower part is made by multistage porous metal material, and through electron beam melting respectively with using fine and close
The middle part 7 that medical metal material titanium alloy is made, which is connected, to be integral.
Wherein, as illustrated in figs. 5-7,1 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 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 | 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 (6)
1. a kind of steady type Invasive lumbar fusion device, it is characterised in that：It is divided into top, middle part（7）With three layers of bottom；The top is
Two strip shape bodies being spaced apart（5）, two strip shape bodies（5）It is located at middle part respectively（7）Two edges of upper surface, two bars
Shape body（5）Between grow into groove for two ends insertions（6）；The middle part（7）Two relative long side surfaces on be respectively equipped with two ends
The groove of insertion（8）；The bottom is two strip shape bodies being spaced apart（9）, two strip shape bodies（9）It is located at middle part respectively（7）
Two edges of lower surface, two strip shape bodies（9）Between grow into groove for two ends insertions（10）；The top and the bottom
It is made by porous metal material, respectively with the middle part（7）It is connected and is integral.
2. steady type Invasive lumbar fusion device as claimed in claim 1, it is characterised in that：Two strip shape bodies on the top（5）It is upper
End and two strip shape bodies of the bottom（9）Lower end be disposed as the double wedge being randomly distributed.
3. steady type Invasive lumbar fusion device as claimed in claim 1 or 2, it is characterised in that：The middle part（7）Two relative long sides
Groove on face（8）Symmetrically.
4. the steady type Invasive lumbar fusion device as described in claim 1-3 is any, it is characterised in that：The porous metal material is using more
Level porous metal material, with three-level hole, its material body is the vestibule being classified with material pore size, and around formation
The cavity wall of vestibule is constituted；Wherein, it is uniformly distributed, is mutually communicated in the cavity wall for the first order vestibule be uniformly distributed, being mutually communicated
Second level vestibule, have the third level vestibule for being uniformly distributed, being mutually communicated in the cavity wall of second level vestibule；And vestibule at different levels is mutual
Between 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 it is suitable with the space boundary of whole material body, and every grade of porous material has physical and chemical performance alone.
5. steady type Invasive lumbar fusion device as claimed in claim 4, it is characterised in that：The multistage porous metal material, same to one-level
The quantity in the hole of one specific dimensions scope of vestibule accounts for more than the 85% of this grade of hole sum.
6. the steady type Invasive lumbar fusion device as described in claim 4 or 5, 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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Application publication date: 20170714 |