CN107397612A - A kind of preparation method of interbody spinal implant - Google Patents
A kind of preparation method of interbody spinal implant Download PDFInfo
- Publication number
- CN107397612A CN107397612A CN201610332408.8A CN201610332408A CN107397612A CN 107397612 A CN107397612 A CN 107397612A CN 201610332408 A CN201610332408 A CN 201610332408A CN 107397612 A CN107397612 A CN 107397612A
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- China
- Prior art keywords
- polymer
- metal material
- porous metal
- spinal implant
- structure body
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/442—Intervertebral or spinal discs, e.g. resilient
Abstract
A kind of first structure body being made up of porous metal material, the preparation method of second structure and the interbody spinal implant formed positioned at above-mentioned thermoplastic polymer structure body between the two, including first by first structure body, second structure segment thickness immerses liquid low melting point, after the solidification of liquid low melting point, two structures are put into injection mold, with high-speed injection molding machine thermoplastic polymer is injected between two structures, the compound of formation is taken out, heating removes first structure body, low melting point in second structure, form interbody spinal implant, the preparation method causes first structure body, second structure is firmly combined with polymer structure, and the polymer thickness for immersing two structures is uniform, it is favorably improved the reliability of compound implant, extend the life-span of compound implant.
Description
Technical field
The present invention relates to a kind of preparation method that can be transplanted to internal prosthese, the particularly system of interbody spinal implant
Preparation Method.
Background technology
The consequence of tumor of spine, Spondylitis disease and the morbidity of unstability vertebral fracture often causes serious vertebra
Body destroys, and then unstable spine and spinal cord, nerve root injury may occur, and causes patient to paralyse what is more.This patient just by
Year increase, is particularly due to aging population and accelerates to increase.And anterior spinal decompression centrum cuts entirely or subtotal ectomy is recognized
To be tumor of spine, Spondylitis disease and the main Clinical Surgery's treatment means of unstability vertebral fracture.Performing the operation
Cheng Zhong, surgeon must rebuild to the backbone for losing complete stability, promote in spinal operation using bone grafting material
Bone fusion, the stability for strengthening backbone.Although autologous bone transplanting is the goldstandard of spinal fusion, but autologous bone transplanting quantity be present
Complication that is limited, taking Limb lengthening operating time, increase Qu Gu areas, can not provide enough instant stability etc. and lack after surgery
Point.Titanium cage and artificial vertebral body spinal implant gradually start clinically to be applied as a kind of effective vertebral body replacements.
But the titanium cage or artificial vertebral body spinal implant used at present is often simple mechanical support material, its own is compared with autologous bone
Acted on without osteoacusis, self-bone grafting and ostosis, on the premise of spinal stability is recovered, it is impossible to promote adjacent spinal section to melt
Close；There is researcher to propose to prepare centrum spinal implant using using porous material, as the A of CN 102612351 describe one kind
Compound implant, the disclosure of the invention is a kind of be easy to adjacent vertebrae fusion Interbody spinal compound implant, the implant
Including first structure body and the second structure made of porous metal material made of porous metal material, first, second
Structure is configured to allow for growing in bone.Implant also includes being positioned between first, second structure and being attached to first
With the polymer structure of the second structure so that the polymeric material of polymer structure penetrates into the first and second soleplates
Kong Zhong, component is combined together, implant also includes the cavity for communicating through compound implant, and the cavity is configured to use
In receiving bone growth material, in order to the fusion between two neighboring vertebra.Its preparation method includes：Make by polymeric material system
Into the first surface of polymer structure be adjacent to the surface positioning of the first structure body made of porous metal material, will be by
First structure body made of porous metal material is heated to the first rise temperature, in the polymer architecture made of polymeric material
Body and by applying compression stress between first structure body made of porous metal material, so that polymeric material is partly into
Made of the porous metal material in the hole of first structure body, make the second table of the polymer structure made of polymeric material
Face be adjacent to the second structure made of porous metal material surface positioning, will made of porous metal material the second knot
Structure body is heated to the second rise temperature, and in the polymer structure made of polymeric material and by porous metal material system
Into the second structure between apply compression stress so that polymeric material is partly into made of porous metal material
In the hole of second structure.
It is that this method makes polymeric material and porous metals that above-mentioned centrum spinal implant preparation method, which has subject matter,
The connection of material is not firm enough.
The content of the invention：
A kind of system for the interbody spinal implant being connected firmly it is an object of the invention to provide polymeric material and porous material
Preparation Method.
It has been recognised by the inventors that irregular due to porous material, existing method is that porous material is pressed into polymer, it is difficult to real
Existing polymer merges completely with porous metal material, and the thickness for penetrating into porous metal material is also uneven, thus and polymer
Material connection is insecure, it is necessary to which new connection method, therefore, inventors herein proposes following technical scheme：
A kind of preparation method of interbody spinal implant, described interbody spinal implant is made of porous metal material
First structure body, the second structure and the polymer knot made of thermoplastic, polymeric materials made of porous metal material
Structure body is formed, and the polymer structure is positioned between first structure body and the second structure；Wherein, first structure body is with gathering
The first bonding layer between compound structure includes penetrating into the polymeric material in the hole of first structure body, the second structure with
The second bonding layer between polymer structure includes penetrating into the polymeric material in the hole of the second structure；And through vertebra
The cavity of spinal implant, its preparation method comprise the following steps between body：
（a）It is low in liquid less than melting point polymer that first structure body made of porous metal material is immersed into a kind of fusing point
In Melting Substance, immersion face is the another side relative with the composition surface of polymer structure, and immersion depth is porous metal material
The total height of manufactured first structure body subtracts the thickness of the first bonding layer, solidifies the low melting point in liquid；
（b）Second structure made of porous metal material is immersed（a）In the described low melting point in liquid, immerse
Face is the one side relative with the composition surface of polymer structure, and immersion depth is the second structure made of porous metal material
Total height subtracts the thickness of the second bonding layer, solidifies the low melting point in liquid；
（c）Will（a）、（b）First structure body made of the porous metal material of preparation, the second structure made of porous metal material
Body is put into injection mold, and each structure is relative with the face that another structure is combined with polymer with the face that polymer combines, often
The individual structure another side relative with the face that polymer combines is fixed, and the distance in the face that two structures are combined with polymer is
The height for the part that polymer structure is not combined with first structure body, the second structure, injection hole are arranged on two structures
Between the face combined with polymer；First structure body, the second structure, which will be put into after injection mold high-speed injection molding machine in 4 seconds, to be melted
Polymer raw material cavity between two structures is filled by injection hole, cool down mould, open injection mold, take out porous
The compound that first structure body made of metal material, the second structure made of porous metal material are formed with polymer；
（d）Will（c）In compound be heated to（a）The fusing point of middle low melting point, makes low melting point and porous metal material
Second structure made of manufactured first structure body, porous metal material separates, and then cleans porous metal material, then carry out
Follow-up machining, that is, be made interbody spinal implant.
Furtherly, the preparation method of described interbody spinal implant, the fusing point of described low melting point is than poly-
Compound fusing point is low more than 70 DEG C, can avoid removing low melting point damage polymer structure.
Furtherly, the preparation method of described interbody spinal implant, described polymer are polyether-ether-ketone
（) or ultrahigh molecular weight polyethylene (UHMWPE) or polymethyl methacrylate (PMMA) PEEK.
Furtherly, the preparation method of described interbody spinal implant, described low melting point are paraffin or shell
Glycan or PLA or polyglycolic acid.
Furtherly, the preparation method of described interbody spinal implant, before injection, porous metal material is made
First structure body and porous metal material made of the part that is combined with polymer of the second structure be roughened, with
Combined more firm with polymer structure beneficial to first structure body, the second structure.
Furtherly, the preparation method of described interbody spinal implant, roughening processing method is sandblasting or pickling
Or differential arc oxidation.
Furtherly, the preparation method of described interbody spinal implant, described porous metal material is by medical titanium
And alloy or medical niobium and alloy or Medical tantalum and alloy or medical stainless steel or Medical Cobalt-Based Alloys or medical magnesium and alloy system
It is standby.
Beneficial effects of the present invention：
（1）The preparation method of interbody spinal implant provided by the invention, the polymer of molten condition is immersed by being molded
Porous metal material forms first structure body and engaged with the first bonding layer of polymer and the second structure with the second of polymer
Layer, and make polymer architecture body formed, the technology mode makes polymeric material and first structure body made of porous metal material
And second structure be tightly combined, be favorably improved the reliability of compound implant, extend the life-span of compound implant, and first
The low melting point in uniform thickness being immersed in structure, the second structure ensure that the polymer thickness of immersion is also equal
Even, high speed injection motding mode avoids low melting point softening and influences the uniformity of polymer thickness.
（2）By making the fusing point of low melting point lower than melting point polymer more than 70 DEG C, be advantageous to protect polymer architecture
Body.
（3）Before injection, by the second structure made of first structure body made of porous metal material, porous metal material
Body is roughened, for combining more between first structure body, the second structure and polymer structure after injection
Firmly it is highly profitable.
Brief description of the drawings
Below in conjunction with accompanying drawing, the present invention is further elaborated with embodiment.
Fig. 1 is interbody spinal implant schematic diagram of the present invention.
Fig. 2 is Fig. 1 top view.
Fig. 3 is the schematic diagram for the low melting point that first structure body made of porous metal material immerses liquid.
Fig. 4 is to be noted in the second structure made of first structure body made of porous metal material, porous metal material
Schematic diagram in mould.
Embodiment
The embodiment of the present invention is explained below in conjunction with the accompanying drawings, 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 implementation
Mode.
As shown in Figure 1 and Figure 2,1 is first structure body, and 2 be the second structure, and 3 be polymer structure, and 4 be cavity, and 5 are
First bonding layer, 6 be the second bonding layer, and H is the total height of interbody spinal implant, T1, T2 be respectively first structure body 1,
The height of second structure 2, T4, T5 are respectively the first bonding layer 5, the thickness of the second bonding layer 6, and T3 is polymer structure 3
The height for the part not combined with first structure body 1, the second structure 2.In Fig. 3,7 be container, and 8 be the eutectic in liquid
Point material.In Fig. 4,9 be the left mould of injection mold, and 10 be the right mould of injection mold, and 11 be injection hole.
Embodiment 1
A kind of interbody spinal implant, the first structure body 1 made of POROUS TITANIUM, the second structure 2 made of POROUS TITANIUM
And polymer structure 3 is formed made of thermoplastic, polymeric materials polyether-ether-ketone (PEEK), the polymer structure 3
It is positioned between the structure 2 of first structure body 1 and second；Wherein, first between first structure body 1 and polymer structure 3
Bonding layer 5 includes penetrating into the polymeric material in the hole of first structure body 1, between the second structure 2 and polymer structure 3
The second bonding layer 6 include the polymeric material penetrated into the hole of the second structure；And through interbody spinal implant
Cavity 4, the POROUS TITANIUM that first structure body and the second structure use prepared with foam impregnation method, and its aperture is 350 μm of -550 μ
M, the thickness T4 of the first binder course 5 and the thickness T6 of the second binder course 6 are respectively 1.8mm, height T1, the second knot of first structure body 1
The height T2 of structure body 2 is respectively 3.8mm, the part that polymer structure 3 is not combined with first structure body 1, the second structure 2
Height T3 is 5.4mm, and the overall height H of interbody spinal implant is 13mm.Its preparation method is：
（a）First structure body 1 made of POROUS TITANIUM is roughened, using micro-arc oxidation process, electrolyte used is matched somebody with somebody
Side：EDTA-2Na contents are 15g/L, Ca (CH3COO)2·H2O content is 8.8g/L, Na2SiO3·9H2O content is 14.2g/
L, NaOH content 20g/L, voltage 400V, frequency 600Hz, dutycycle 8%, oxidization time 5min, then by first
Structure 1 immerses container 7 and is in the low melting point 8 of liquid（The present embodiment low melting point is polyglycolic acid）, immerse face
For the another side relative with the composition surface of polymer structure 3, immersion depth is total height of first structure body 1 made of POROUS TITANIUM
Degree T1 subtracts thickness T4, the i.e. T1-T4=3.8mm-1.8mm=2mm of the first bonding layer, cooling, makes the polyglycolic acid in liquid
Solidification；
（b）Similarly, the second structure 2 made of POROUS TITANIUM is also carried out（a）Described differential arc oxidation processing, is then immersed in
（a）In described container 7 in the polyglycolic acid in liquid, face of immersing is relative with the composition surface of polymer structure one
Face, immersion depth are that the total height T2 of the second structure 2 made of POROUS TITANIUM subtracts the thickness T5 of the second bonding layer, i.e. T2-T5=
3.8mm-1.8mm=2mm, cooling, solidify the polyglycolic acid in liquid；
（c）Will（a）、（b）First structure body 1 made of the POROUS TITANIUM of preparation, the second structure 2 made of POROUS TITANIUM are put into injection
Mould, first structure body 1 are fixed in the inner end of left mould 9, and it immerses the part of polyglycolic acid close to the inner end of left mould 9, and second
Structure 2 is fixed in the inner end of right mould 10, and it immerses the part of polyglycolic acid close to the inner end of right mould 9, each structure with
Polymer combine face it is relative with the face that another structure is combined with polymer, the face that two structures are combined with polymer away from
It is 5.4mm from the height T3 for the part not combined for polymer structure 3 with first structure body 1, the second structure 2, injection hole
11 are arranged between the face that two structures are combined with polymer；First structure body, the second structure are put into after injection mold 4 seconds
Interior high-speed injection molding machine fills the polymer raw material polyether-ether-ketone (PEEK) of fusing between two structures by injection hole 11
Cavity, injection pressure take 152MPa, and injection rate takes 94 cm3/s, is water-cooled mould, then open injection mold, take out the
The compound that one structure, the second structure are formed with polymer.
（d）Will（c）In compound be heated to 225 DEG C of the fusing point of polyglycolic acid, make polyglycolic acid and first structure body 1,
Second structure 2 separates, and then cleans first structure body 1, the second structure 2, then carries out rising head, after processing the grade of cavity 4
Continuous machining, that is, be made interbody spinal implant.
In the present embodiment, polymer poly ether ether ketone (PEEK) differs 118 DEG C with the fusing point of low melting point polyglycolic acid.
Using compound implant produced by the present invention, the engagement of polymer structure and first and second structure is close, and first
Bonding layer, the second bonding layer thickness are uniform, are favorably improved the reliability of compound implant, extend the life-span of compound implant,
And make the bone tissue that grows into uniform.
Embodiment 2
The interbody spinal implant of the present embodiment, the first structure body 1 made of porous niobium, the second knot made of porous niobium
Structure body 2 and polymer structure 3 is formed made of thermoplastic, polymeric materials polymethyl methacrylate (PMMA), it is described
Polymer structure 3 is positioned between the structure 2 of first structure body 1 and second；Wherein, first structure body 1 and polymer architecture
The first bonding layer 5 between body 3 includes penetrating into the polymeric material in the hole of first structure body 1, and the second structure 2 is with polymerizeing
The second bonding layer 6 between thing structure 3 includes penetrating into the polymeric material in the hole of the second structure；And through centrum
Between spinal implant cavity 4, the porous niobium that first structure body and the second structure use prepared with foam impregnation method, its aperture
For 300 μm -500 μm, the thickness T4 of the first binder course 5 and the thickness T6 of the second binder course 6 are respectively 1.6mm, the height of first structure body 1
Degree T1, the height T2 of the second structure 2 are respectively 4.1mm, polymer structure 3 not with first structure body 1, the second structure 2
With reference to the height T3 of part be 5.8mm, the overall height H of interbody spinal implant is 14mm.Its preparation method and embodiment 1
Similar, difference is that roughening handling process is pickling：Mix acid liquor concentration is used as the pure nitric acid of 35% analysis and 15% analysis
Pure hydrofluoric acid is carried out；Low melting point takes paraffin, polymeric material polymethyl methacrylate (PMMA) and low melting point stone
The fusing point of wax differs 87 DEG C.
Embodiment 3
The interbody spinal implant of the present embodiment, the first structure body 1 made of porous tantalum, the second knot made of porous tantalum
Structure body 2 and polymer structure 3 is formed made of thermoplastic, polymeric materials ultrahigh molecular weight polyethylene (UHMWPE), institute
Polymer structure 3 is stated to be positioned between the structure 2 of first structure body 1 and second；Wherein, first structure body 1 and polymer knot
The first bonding layer 5 between structure body 3 includes penetrating into the polymeric material in the hole of first structure body 1, and the second structure 2 is with gathering
The second bonding layer 6 between compound structure 3 includes penetrating into the polymeric material in the hole of the second structure；And through vertebra
The porous tantalum that the cavity 4 of spinal implant between body, first structure body and the second structure use is prepared with foam impregnation method, its hole
Footpath is 400 μm -600 μm, and the thickness T4 of the first binder course 5 and the thickness T6 of the second binder course 6 are respectively 1.5mm, first structure body 1
Height T1, the height T2 of the second structure 2 are respectively 4mm, polymer structure 3 not with first structure body 1, the second structure 2
With reference to the height T3 of part be 5mm, the overall height H of interbody spinal implant is 13mm.Its preparation method and the phase of embodiment 1
Seemingly, difference is that roughening handling process is sandblasting：The face combined to first structure body 1, the second structure 2 with polymer is entered
Row blasting treatment, nozzle of sand spraying machine pressure is 0.5MPa, using 70~90 mesh Al2O3Abrasive material；Low melting point takes paraffin, injection
Pressure takes 168MPa, and injection rate takes 148cm3/s, polymeric material ultrahigh molecular weight polyethylene (UHMWPE) and low-melting-point material
Matter melting point of paraffin wax differs 73 DEG C.
Claims (7)
1. a kind of preparation method of interbody spinal implant, described interbody spinal implant are made up of porous metal material
First structure body, the second structure and the polymer made of thermoplastic, polymeric materials made of porous metal material
Structure is formed, and the polymer structure is positioned between first structure body and the second structure；Wherein, first structure body with
The first bonding layer between polymer structure includes penetrating into the polymeric material in the hole of first structure body, the second structure
The second bonding layer between polymer structure includes penetrating into the polymeric material in the hole of the second structure；And run through
The cavity of interbody spinal implant, it is characterised in that preparation method comprises the following steps：
（a）It is low in liquid less than melting point polymer that first structure body made of porous metal material is immersed into a kind of fusing point
In Melting Substance, immersion face is the another side relative with the composition surface of polymer structure, and immersion depth is porous metal material
The total height of manufactured first structure body subtracts the thickness of the first bonding layer, solidifies the low melting point in liquid；
（b）Second structure made of porous metal material is immersed（a）In the described low melting point in liquid, immerse
Face is the one side relative with the composition surface of polymer structure, and immersion depth is the second structure made of porous metal material
Total height subtracts the thickness of the second bonding layer, solidifies the low melting point in liquid；
（c）Will（a）、（b）First structure body made of the porous metal material of preparation, the second structure made of porous metal material
Body is put into injection mold, and each structure is relative with the face that another structure is combined with polymer with the face that polymer combines, often
The individual structure another side relative with the face that polymer combines is fixed, and the distance in the face that two structures are combined with polymer is
The height for the part that polymer structure is not combined with first structure body, the second structure, injection hole are arranged on two structures
Between the face combined with polymer；First structure body, the second structure, which will be put into after injection mold high-speed injection molding machine in 4 seconds, to be melted
Polymer raw material cavity between two structures is filled by injection hole, cool down mould, open injection mold, take out porous
The compound that first structure body made of metal material, the second structure made of porous metal material are formed with polymer；
（d）Will（c）In compound be heated to（a）The fusing point of middle low melting point, makes low melting point and porous metal material
Second structure made of manufactured first structure body, porous metal material separates, and then cleans porous metal material, then carry out
Follow-up machining, that is, be made interbody spinal implant.
2. the preparation method of interbody spinal implant as claimed in claim 1, it is characterised in that：Described low melting point
Fusing point it is lower than melting point polymer more than 70 DEG C.
3. the preparation method of interbody spinal implant as claimed in claim 1 or 2, it is characterised in that：Described polymer
For polyether-ether-ketone（) or ultrahigh molecular weight polyethylene (UHMWPE) or polymethyl methacrylate (PMMA) PEEK.
4. the preparation method of interbody spinal implant as claimed in claim 1 or 2, it is characterised in that：Described low melting point
Material is paraffin or chitosan or PLA or polyglycolic acid.
5. the preparation method of the interbody spinal implant as described in Claims 1-4 any claim, it is characterised in that：
Before low melting point is immersed, by the second structure made of first structure body made of porous metal material and porous metal material
The part that body is combined with polymer is roughened.
6. the preparation method of interbody spinal implant as claimed in claim 5, it is characterised in that：Being roughened processing method is
Sandblasting is pickling or is differential arc oxidation.
7. the preparation method of the interbody spinal implant as described in claim 1 to 6 any claim, it is characterised in that：
Described porous metal material is by medical titanium and alloy or medical niobium and alloy or Medical tantalum and alloy or medical stainless steel or doctor
Prepared with cobalt-base alloys or medical magnesium and alloy.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610332408.8A CN107397612B (en) | 2016-05-19 | 2016-05-19 | Preparation method of intervertebral spinal implant |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610332408.8A CN107397612B (en) | 2016-05-19 | 2016-05-19 | Preparation method of intervertebral spinal implant |
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| Publication Number | Publication Date |
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| CN107397612A true CN107397612A (en) | 2017-11-28 |
| CN107397612B CN107397612B (en) | 2020-03-27 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201610332408.8A Active CN107397612B (en) | 2016-05-19 | 2016-05-19 | Preparation method of intervertebral spinal implant |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101238166A (en) * | 2005-07-01 | 2008-08-06 | 金文申有限公司 | Process for production of porous reticulated composite materials |
| CN102612351A (en) * | 2009-09-23 | 2012-07-25 | 捷迈脊柱有限公司 | Composite implant |
| CN102821716A (en) * | 2010-02-04 | 2012-12-12 | 芬斯贝利(发展)有限责任公司 | Prosthesis |
| US20140044861A1 (en) * | 2009-02-11 | 2014-02-13 | Nanyang Technological University | Multi-layered surgical prosthesis |
-
2016
- 2016-05-19 CN CN201610332408.8A patent/CN107397612B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101238166A (en) * | 2005-07-01 | 2008-08-06 | 金文申有限公司 | Process for production of porous reticulated composite materials |
| US20140044861A1 (en) * | 2009-02-11 | 2014-02-13 | Nanyang Technological University | Multi-layered surgical prosthesis |
| CN102612351A (en) * | 2009-09-23 | 2012-07-25 | 捷迈脊柱有限公司 | Composite implant |
| CN102821716A (en) * | 2010-02-04 | 2012-12-12 | 芬斯贝利(发展)有限责任公司 | Prosthesis |
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| Publication number | Publication date |
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| CN107397612B (en) | 2020-03-27 |
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