CN107569306A - A kind of spinal implant - Google Patents

A kind of spinal implant Download PDF

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Publication number
CN107569306A
CN107569306A CN201610514579.2A CN201610514579A CN107569306A CN 107569306 A CN107569306 A CN 107569306A CN 201610514579 A CN201610514579 A CN 201610514579A CN 107569306 A CN107569306 A CN 107569306A
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hole
spinal implant
vestibule
diameter
level
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CN201610514579.2A
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CN107569306B (en
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叶雷
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Chongqing Runze Pharmaceutical Co Ltd
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Chongqing Runze Pharmaceutical Co Ltd
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Abstract

A kind of spinal implant,It is prepared by porous material,The spinal implant includes straight front end,The rear end of evagination,The both ends of extension are extended between front and rear end,The arch upper surface of middle evagination,Flat lower surface,There is a through hole between upper surface to lower surface,There is a through hole in rear end,Extend inwards from rear end and upper surface penetrates to the through hole lower surface,Porous material is the multilevel hole material with multistage vestibule being classified with material pore size,Every grade of vestibule is each mutually communicated and vestibule at different levels also penetrates each other each other,The porosity of the minimum level bore portion material of the multilevel hole material is not less than 50%,Upper surface and lower surface Jun You holes,The spinal implant contributes to spinal implant to carry the medicines such as more bone growth factors,Acceleration spinal implant merges with surrounding bone,Expand the faying face of spinal implant and bone,Make spinal implant and merging for bone more firm.

Description

A kind of spinal implant
Technical field
The present invention relates to a kind of prosthese, particularly spinal implant.
Background technology
Spinal stabilization caused by vertebra retrogression pathological changes, Segmental defect, wound etc. decline etc. may cause pain, Limb motion sensory disturbance, the state of an illness it is slight can reach alleviations by non-operative treatment, and to non-operative treatment nonresponder with The heavier patient of symptom then needs row operative treatment.Anterior spinal decompression centrum cuts entirely or subtotal ectomy is considered as main hand Art treatment means.In surgical procedure, surgeon need to rebuild to the backbone for losing complete stability, in the past conventional side Method is to carry out transplanting filling Reconstruction of vertebral bone defects using autologous ilium.But simple autologous bone transplanting exist autologous Bone mineral change and The shortcomings of enough instant stability can not be provided after surgery.Titanium cage and artificial vertebral body are as a kind of effective spinal implant Gradually it is widely applied clinically.But the titanium cage or artificial vertebral body used at present is simple mechanical support material, its No osteoacusis, self-bone grafting and ostosis effect itself are compared with autologous bone, on the premise of spinal stability is recovered, it is impossible to promote Merge adjacent spinal section.Later, it has been proposed that preparing spinal implant using porous material, as the A of CN 103961746 are introduced A kind of bion spinal interbody fusion device, including the loose structure on surface and internal three-dimensional porous bone tissue engineering support knot Structure, the loose structure on the surface and internal three-dimension porous tissue engineering supporting structure are interconnected, can by metal, ceramics, It is prepared by natural or synthetic high polymer material.The A1 of US 2008/0200985 describe a kind of spinal implant, by porous material system Standby, the spinal implant includes usually straight front end, the rear end of evagination, the both ends for extending between front end, rear end extension, generally Arch upper surface, the flat lower surface of middle evagination.This kind of spinal implant helps to recover spinal stability.Above-mentioned backbone Implant employs the porous material of single hole, on the one hand, the medicine such as bone growth factor that material can store deficiency in itself, In addition, it is opposed flattened with the surface of synosteosis, cause spinal implant and merging for surrounding bone slow, fusion is built on the sand.Zou X etc. Research(Bone ingrowth characteristics of porous tantalum and carbon fiber interbody devices:an experimental study in pigs[J] Spine J. 2004, 4(1):99- 105)Show, making Invasive lumbar fusion device with the porous tantalum of the single hole of tradition carries out zoopery, and porous new material is carried out Histotomy finds that bone tissue often only grows into the outward flange of porous material top layer hole or hole, do not cover with material internal Hole.
The content of the invention:
Firm, fusion speed is merged soon so that the backbone of spinal stabilization with adjacent bone tissue it is an object of the invention to provide a kind of Implant.
It has been recognised by the inventors that needing to enable spinal implant to carry the medicines such as more bone growth factors, and improved structure, increase Add makes spinal implant be merged with adjacent bone tissue with the faying face of bone consolidates, therefore, inventor proposes following scheme:
A kind of spinal implant, it is prepared by porous material, and the spinal implant includes straight front end, the rear end of evagination, preceding The both ends of extension, arch upper surface, the flat lower surface of middle evagination, between upper surface to lower surface are extended between end and rear end There is a through hole, available for bone grafting is clogged, there is a through hole in rear end, extend inwards from rear end and upper surface is to logical lower surface Hole is penetrated, and operation instrument is inserted during for implant surgery, and the porous material is multilevel hole material, and the multilevel hole material is by with material The vestibules at different levels that blanking aperture size is classified, and formed around the cavity walls at different levels for forming vestibule;In three dimensions around composition The cavity wall of higher level's vestibule is made up of subordinate's porous material, every grade of vestibule be each mutually communicated and vestibule at different levels each other also each other Insertion, the porosity of the minimum level bore portion material of the multilevel hole material are not less than 50%, and above-mentioned porosity only refers to minimum level hole portion The porosity of point material, that is, when calculating, only take the material in minimum level hole, the ratio between the hole in minimum level hole and material for being taken are The porosity of minimum level bore portion material;Upper surface, lower surface Shang You holes, spinal implant is contributed to carry more bone uptakes The medicines such as the factor, accelerate merging for spinal implant and surrounding bone, the hole on upper surface, lower surface expand spinal implant with The faying face of bone, and the bone tissue grown into hole can play support effect, make spinal implant and merging for bone more firm.
Furtherly, described spinal implant, there is hole on described upper surface to the through-hole wall between lower surface, make to lead to The bone grafting clogged in hole merges more firm with spinal implant.
Furtherly, described spinal implant, hole or upper surface to lower surface on described upper surface and lower surface Between through-hole wall on hole be equally distributed, make the adhesion of spinal implant and bone uniform.
Furtherly, described spinal implant, the diameter in described hole are not less than 2mm, and the depth in hole is diameter 0.4-1 times, the hole of the size make it that spinal implant and merging for bone are more firm.
Furtherly, described spinal implant, described hole are taper hole, the big end of taper hole on surface, taper hole small end it is straight Footpath is not less than 2mm, and the depth in hole is 0.4-1 times of diameter, and taper hole makes the bond strength of spinal implant and bone higher.
Furtherly, described spinal implant, when the multilevel hole material hierarchical level is three-level, first order vestibule Aperture is micrometer grade hole, and third level vestibule aperture is nano grade pore, and the aperture of second level vestibule is between first order vestibule and the 3rd Between the aperture of level vestibule, the spinal implant of this kind of material preparation and merging faster for bone, more firm stable.
Furtherly, described spinal implant, the aperture in the maximum one-level hole of described multilevel hole material for 100 μm- 600 μm, it is beneficial to bone tissue and grows into.
Furtherly, described spinal implant, the porous material be porous metal material, porous non-metallic material or Porous metals and nonmetallic composite.Described porous metal material includes medical titanium and alloy, medical niobium and alloy, doctor With tantalum and alloy, medical stainless steel, Medical Cobalt-Based Alloys, medical magnesium and alloy etc., described is nonmetallic including medical ceramic, doctor With polymer etc..
Beneficial effects of the present invention:
(1)Spinal implant provided by the invention, prepared as a result of multilevel hole material, the cavity wall Shang You subordinates in higher level hole Hole, the particularly porosity of minimum level bore portion material are not less than 50%, so that the specific surface area of material dramatically increases, because And the medicine such as bone growth factor that material can carry also dramatically increases, so as to contribute to after implantation in medicines such as bone growth factors Under continuous action, spinal implant accelerates to merge with bone tissue.
(2)The hole on hole and upper surface to the through-hole wall between lower surface on upper surface, lower surface expands backbone plant Enter the faying face of body and bone, and the bone tissue grown into hole can play support effect, make the combination of spinal implant and bone more Add firmly.
(3)Spinal implant provided by the invention, the three-level hole that the porous metal material of hierarchical porous structure used uses are tied Structure merges after being particularly conducive to spinal implant implantation with bone tissue, and first order vestibule size is beneficial to meet what tissue was grown into Demand, second level vestibule are beneficial to living away from home for various kinds of cell, and third level vestibule is beneficial to meet sticking, breaking up need for cell Ask.
Brief description of the drawings
Below in conjunction with accompanying drawing, the present invention is further elaborated with embodiment.
Fig. 1 is spinal implant schematic diagram of the present invention;
Fig. 2 is Fig. 1 left view;
Fig. 3 is Fig. 1 top view;
Fig. 4 is Fig. 1 rearview;
Fig. 5 is spinal implant schematic diagram in embodiment 3;
Fig. 6 is Fig. 5 A-A sectional views;
Fig. 7 is spinal implant schematic diagram in embodiment 4;
Fig. 8 is the sectional view B-B of surface taper hole in embodiment 4;
Fig. 9 is multilevel hole material structural representation.
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 illustrated, 1 is the front end of spinal implant, 2 be spinal implant rear end, and 3 extend between front and rear end and prolong The end face stretched, 4 be spinal implant upper surface, 5 be spinal implant lower surface, 6 be upper surface between lower surface Through hole, 7 be the through hole of rear end, and 8 be the hole of upper surface, and 9 be the hole of lower surface, and 10 be upper surface to the through-hole wall between lower surface On hole, 11 be taper hole.Fig. 9 shows that multilevel hole material structure be two level Porous materials, and 12 be macropore, 13 for macropore cavity wall, 14 For the aperture in macropore cavity wall 13.
Embodiment 1
A kind of spinal implant, prepared using the porous Co-base alloy material CoCrMo of two level pore structure, macropore vestibule aperture is 100 μm -350 μm, hole is mutually communicated, and small aperture is 400nm-650nm in macropore cavity wall, and aperture is also to be mutually communicated , it is also what is be mutually communicated between macropore and aperture, the porosity of aperture is 50%, has a diameter of 2mm on upper surface, lower surface, Depth is 0.4 times of its diameter, i.e. 0.8mm hole, and spacing is 2mm between hole.Its preparation method is:
1st, prepared by multilevel hole material
A. material prepares
It for 100nm-150nm cobalt-base alloys CoCrMo powder is raw material to use particle diameter, and particle diameter is 500nm-750nm Methyl cellulose Element is as minimum level hole pore creating material, by the use of the polystyrene that particle diameter is 500nm-750nm as adhesive, according to cobalt-based alloy powder: Methylcellulose:Polystyrene:Distilled water by volume 2:1:1:8 are configured to slurry.
Using a diameter of 180 μm -430 μm of polyester form of rib, the slurry is uniformly filled wherein with foam impregnation method, Base substrate and drying are formed, then crushes and obtains the mixing containing raw material, pore creating material and polyester form that particle is 180 μm -430 μm Particle.
B. hybrid particles are put into mould, are pressed into dense green.
C. by dense green vacuum-sintering;Base substrate after sintering carries out follow-up according to cobalt-base alloys CoCrMo common process Processing obtains the porous Co-base alloy material that series is two level.
2nd, spinal implant is processed
The shape and size of the spinal implant as shown in structure chart are processed with machine-tooled method.
Embodiment 2
The present embodiment is similar to Example 1, and difference is that material is pure titanium, and the porosity of aperture is 55%, upper surface, following table There is a diameter of 2.5mm on face, depth is 1 times of its diameter, i.e. 2.5mm hole, and spacing is 3mm between hole.Preparation method and embodiment 1 It is similar.
Embodiment 3
The present embodiment is similar to Example 1, and difference is that material is niobium, and the porosity of aperture is 53%, upper surface, lower surface And upper surface is to there is a diameter of 2.2mm on the through-hole wall between lower surface, depth is 0.6 times of its diameter, i.e. 1.32mm hole, hole Between spacing be 2.5mm.Preparation method is similar to Example 1.
Embodiment 4
The present embodiment is similar to Example 1, and difference is that material is carbonyl apatite, and the porosity of aperture is 60%, macropore hole Footpath is 400 μm -600 μm, has taper hole on upper surface, lower surface, and taper hole end diameter is 2.5mm, and big end is 3.2mm, and depth is 0.4 times of taper hole end diameter, i.e. 1mm, spacing is 3.5mm between hole.Preparation method is similar to Example 1.
Embodiment 5
The present embodiment is similar to Example 4, and difference is that material is Stainless steel 316 L, and the porosity of aperture is 68%, macropore hole Footpath is 300 μm -550 μm, there is taper hole on upper surface, lower surface and upper surface to the through-hole wall between lower surface, and taper hole small end is straight Footpath is 2mm, and big end is 3mm, and depth is 1 times, i.e. 2mm of end diameter, and spacing is 3mm between hole.Preparation method and the phase of embodiment 1 Seemingly.
Embodiment 6
A kind of spinal implant, prepared using the porous tantalum material of three-level pore structure, first order vestibule aperture is 350 μm of -500 μ M, second level vestibule aperture are 30 μm -90 μm, and third level vestibule aperture is 300nm-600nm, porosity 65%.Upper surface, under To having taper hole on the through-hole wall between lower surface, taper hole end diameter is 2.2mm for surface and upper surface, and big end is 3.5mm, depth For 0.8 times of taper hole end diameter, i.e. 1.76mm, spacing is 3.8mm between hole.Its preparation method is similar to Example 1, is not both In the preparation of porous tantalum material, by broken obtained hybrid particles, ethyl cellulose that particle diameter is 40 μm -100 μm by volume 1:3 uniformly mixing, pour into the polyester form that rib is a diameter of 400 μm -600 μm, 600 μm -800 μm of three-dimensional insertion is in aperture, It is put into mould and is pressed into dense green, by dense green vacuum-sintering;Base substrate after sintering carries out conventional follow-up according to tantalum material technique The porous tantalum material that hole series is three-level is thermally treated resulting in, then machining spinal implant shape and size again.
Several spinal implants and same material of inventor's foregoing invention but the only spinal implant in maximum level hole Implantation Test has been carried out to small ox back vertebra, implant is immersed to cryopreserved viable artery growth factor solution before implantation, it is carried bone Growth factor, the results showed that, after 12 weeks, bone tissue covers with inside the implant of the present invention completely, this kind of spinal implant and week Bone tissue is enclosed closely to merge, interface consolidates, only the spinal implant of the single hole in maximum level hole after 15 weeks bone tissue grow into Depth less than 3mm, is not covered with inside spinal implant still completely.

Claims (10)

1. a kind of spinal implant, it is prepared by porous material, the spinal implant include straight front end, evagination rear end, The both ends of extension are extended between front and rear end, arch upper surface, the flat lower surface of evagination, are had between upper surface to lower surface One through hole, there is a through hole in rear end, extend inwards from rear end and upper surface penetrates to the through hole lower surface, its feature exists In:The porous material is multilevel hole material, the multilevel hole material by the vestibules at different levels that are classified with material pore size, and Formed around the cavity walls at different levels for forming vestibule;The cavity wall for forming higher level's vestibule is surrounded by subordinate's porous material structure in three dimensions Into every grade of vestibule is each mutually communicated and vestibule at different levels also penetrates each other each other, the minimum level hole portion of the multilevel hole material Divide the porosity of material not less than 50%, upper surface and lower surface Shang Junyou holes.
2. spinal implant as claimed in claim 1, it is characterised in that:Upper surface is to having on the through-hole wall between lower surface Hole.
3. spinal implant as claimed in claim 1 or 2, it is characterised in that:Hole on described upper surface and lower surface or Hole on upper surface to the through-hole wall between lower surface is equally distributed.
4. spinal implant as claimed in claim 1 or 2, it is characterised in that:The diameter in described hole is not less than 2mm, hole Depth is 0.4-1 times of diameter.
5. spinal implant as claimed in claim 3, it is characterised in that:The diameter in described hole is not less than 2mm, the depth in hole For 0.4-1 times of diameter.
6. spinal implant as claimed in claim 1 or 2, it is characterised in that:Described hole is taper hole, and the big end of taper hole is in table Face, the diameter of taper hole small end are not less than 2mm, and the depth in hole is 0.4-1 times of diameter.
7. spinal implant as claimed in claim 3, it is characterised in that:Described hole is taper hole, and the big end of taper hole is in surface, cone The diameter of hole small end is not less than 2mm, and the depth in hole is 0.4-1 times of diameter.
8. the spinal implant as described in claim 1 to 7 any claim, it is characterised in that:The multilevel hole material point Level series is when being three-level, and the aperture of first order vestibule is micrometer grade hole, and third level vestibule aperture is nano grade pore, second level vestibule Aperture between the aperture of first order vestibule and third level vestibule.
9. the spinal implant as described in claim 1 to 8 any claim, it is characterised in that:Described multilevel hole material Maximum one-level hole aperture be 100 μm -600 μm.
10. the spinal implant as described in claim 1 to 9 any claim, it is characterised in that:Porous material is porous gold Belong to material, porous non-metallic material or porous metals and nonmetallic composite.
CN201610514579.2A 2016-07-04 2016-07-04 Spinal implant Active CN107569306B (en)

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CN107569306B CN107569306B (en) 2020-10-09

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109953840A (en) * 2019-04-04 2019-07-02 山东新华联合骨科器材股份有限公司 Zero incisura anterior cervical interbody fusion cage of 3D printing

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CN101180011A (en) * 2005-05-02 2008-05-14 活动脊柱技术有限公司 Artificial vertebral body
CN101203195A (en) * 2005-04-26 2008-06-18 新特斯有限责任公司 Spinal implant
US20080200985A1 (en) * 2007-02-19 2008-08-21 Zimmer Spine, Inc. Spinal implant
US20080208342A1 (en) * 2007-02-27 2008-08-28 Zimmer Spine, Inc. Spinal implant
US20100010513A1 (en) * 2008-07-14 2010-01-14 Korean Institute Of Machinery & Materials Porous material having hierarchical porous structure and preparation method thereof
CN105233347A (en) * 2015-10-30 2016-01-13 吉林大学 3D-printed gradient-diameter medical porous metal bone tissue scaffold

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101203195A (en) * 2005-04-26 2008-06-18 新特斯有限责任公司 Spinal implant
CN101180011A (en) * 2005-05-02 2008-05-14 活动脊柱技术有限公司 Artificial vertebral body
US20080200985A1 (en) * 2007-02-19 2008-08-21 Zimmer Spine, Inc. Spinal implant
US20080208342A1 (en) * 2007-02-27 2008-08-28 Zimmer Spine, Inc. Spinal implant
US20100010513A1 (en) * 2008-07-14 2010-01-14 Korean Institute Of Machinery & Materials Porous material having hierarchical porous structure and preparation method thereof
CN105233347A (en) * 2015-10-30 2016-01-13 吉林大学 3D-printed gradient-diameter medical porous metal bone tissue scaffold

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109953840A (en) * 2019-04-04 2019-07-02 山东新华联合骨科器材股份有限公司 Zero incisura anterior cervical interbody fusion cage of 3D printing

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