CN104434346A - Cervical vertebra interbody fusion cage - Google Patents
Cervical vertebra interbody fusion cage Download PDFInfo
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- CN104434346A CN104434346A CN201410635830.1A CN201410635830A CN104434346A CN 104434346 A CN104434346 A CN 104434346A CN 201410635830 A CN201410635830 A CN 201410635830A CN 104434346 A CN104434346 A CN 104434346A
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Abstract
The invention relates to a cervical vertebra interbody fusion cage. The cervical vertebra interbody fusion cage comprises a fusion cage body and an anterior cervical approach fixing plate, wherein the fusion cage body and the anterior cervical approach fixing plate are made of a medical degradable material, the fusion cage body is in the shape of a wedge which becomes lower from front to back, a first fixing hole used for being connected with the front end of the fusion cage body is formed in the middle of the anterior cervical approach fixing plate, and second fixing holes used for being connected with the cervical vertebra are formed in the upper end and lower end of the anterior cervical approach fixing plate respectively. By fixing the anterior cervical approach fixing plate and the fusion cage body which are made of the medical degradable material together, the whole cervical vertebra interbody fusion cage can be fixed to the upper centrum and lower centrum and prevented from sliding forwards to disengage or backwards to press the central nervous system. Due to the fact that both the anterior cervical approach fixing plate and the fusion cage body are made of the medical degradable material, automatic degradation can be achieved after an operation, the discomfortableness of a patient is relieved effectively, and another operation for removal is avoided.
Description
Technical field
The present invention relates to Invasive lumbar fusion device technology, more particularly, relate to a kind of cervical fusion cage.
Background technology
Invasive lumbar fusion device (interbody fusion cage), also spinal fusion device (spine cage) is often referred to as, it is a kind of medical apparatus and instruments conventional in Intervertebral disc fusion operation clinically, be used for total disc replacement, after removing pathological changes/downright bad intervertebral disc, insert the Invasive lumbar fusion device that autologous bone or other bone-grafting material are housed, effectively can play and at once stablize, strut and maintain disc height, promote the effect that vertebral body adjacent segment merges.
The Invasive lumbar fusion device of current Clinical practice mainly adopts the materials such as titanium alloy, rustless steel, polyether-ether-ketone, carbon fiber, homogeneous allogenic bone to make.But these materials all can not be degraded and absorbed in physiological environment, thus after the implantation using forever residing in body as foreign body, not desirable bone renovating material.
In recent years, people utilize degradable biomaterial (as polylactic acid) to develop degradable in vivo absorption Invasive lumbar fusion device.This kind of Invasive lumbar fusion device can provide effective mechanical support for intervertebral fusion at the initial stage of implanting, and maintains disc height.Along with the carrying out of Intervertebral disc fusion, the material of Invasive lumbar fusion device is degraded gradually, for the freshman bone tissue of patient provides growing space, and finally degradable, two adjacent segments realize merging completely simultaneously, reach the therapeutic purposes of intervertebral fusion.Poly-lactic acid material can be broken down into lactic acid molecules in degradation process, in the middle of the tricarboxylic acid cycle participating in human body, and is finally decomposed into water and carbon dioxide and excretes.
But; for the needs preventing Invasive lumbar fusion device slippage forward, improve the stability of adjacent Fusion levels, maintain the aspect such as disc height and physiological camber; usually also need in the cervical intervertebral fusion on premenstrual road on hypocentrum be fixed; this kind of fixture uses anterior cervical titanium plate (or corrosion resistant plate), there is no the anterior approach fixing head of absorbable material at present.Therefore, even if current cervical intervertebral fusion adopts absorbable interbody cage, also need to use anterior cervical titanium plate/corrosion resistant plate to be fixed, there is following several respects shortcoming:
1. anterior cervical titanium plate/corrosion resistant plate causes compressing to esophagus and neighbouring muscle thereof, tissue, and make patient have foreign body sensation and sense of discomfort for a long time, especially when swallowing, foreign body sensation is obvious;
2., after the cervical vertebra two segment of row interbody fusion merges, anterior cervical titanium plate/corrosion resistant plate need be taken out by second operation, adds patient suffering and financial burden;
3. the elastic modelling quantity due to degradable biomaterials such as polylactic acid is much lower for titanium, stainless steel and other metal materials, and the high elastic modulus of anterior cervical titanium plate/corrosion resistant plate forms stress shielding in the front of intervertebral space, is unfavorable for intervertebral shape bone osteogenic fusion;
4. anterior cervical titanium plate/corrosion resistant plate is only formed Invasive lumbar fusion device in front portion and stops, and not to be fixed together with Invasive lumbar fusion device, to cause Invasive lumbar fusion device easily to retrolisthesis, will oppress nervus centralis after entering canalis spinalis, the serious consequence such as cause that pain is even paralysed.
Summary of the invention
The technical problem to be solved in the present invention is, adopt independent titanium plate or corrosion resistant plate in front end, fusion device to be stopped to the problem that there is above-mentioned defect for existing cervical fusion cage, provide a kind of and adopt medical degradable material to make anterior approach fixing head and the cervical fusion cage be fixed together with fusion device main body.
The technical solution adopted for the present invention to solve the technical problems is: construct a kind of cervical fusion cage, comprise fusion device main body and anterior approach fixing head, described fusion device main body and anterior approach fixing head are made by medical degradable material, described fusion device main body is wedge shape low after front height, have the first fixing hole for being connected with described fusion device body front end in the middle part of described anterior approach fixing head, the described upper and lower two ends of anterior approach fixing head are also respectively equipped with the second fixing hole for being connected with cervical vertebra.
According in cervical fusion cage of the present invention, described fusion device principal length is 14.0-16.0mm, and width is 12.0-14.0mm, is highly 6.0-9.0mm; And the difference in height of described fusion device body front end and rear end is more than 1mm.
According in cervical fusion cage of the present invention, the upper surface of described fusion device main body and lower surface are provided with that the degree of depth is 0.3-0.8mm, spacing is the dentalation of 1.5-2.5mm.
According in cervical fusion cage of the present invention, described fusion device main body is provided with the vertical through hole penetrating described upper surface and lower surface; Described vertical through hole is the cylindrical of diameter 3-6mm or square for length of side 3-6mm, and described vertical through hole edge is not less than 3mm to the distance in described fusion device body rear face.
According in cervical fusion cage of the present invention, described fusion device main body is also provided with and penetrates left and right side and the horizontal through hole be communicated with described vertical through hole, and described horizontal through hole is the cylindrical of diameter 3-4mm.
According in cervical fusion cage of the present invention, the height of described anterior approach fixing head is 20.0-28.0mm, and width is 8.0-12.0mm, and thickness is 1.5-3.0mm, and the two ends up and down of described anterior approach fixing head are circular arc or square.
According in cervical fusion cage of the present invention, described fusion device main body is 80-140MPa along the comprcssive strength of short transverse; The bending strength of described anterior approach fixing head is 40-70MPa.
According in cervical fusion cage of the present invention, the degradation time of described fusion device main body is 6-24 month, and the degradation time of described anterior approach fixing head is 3-12 month.
According in cervical fusion cage of the present invention, described fusion device main body is made up of one or more medical degradable polymeric materials following: polylactic acid, polyglycolic acid, Poly(D,L-lactide-co-glycolide and polycaprolactone; The molecular weight of described medical degradable polymeric material is 50,000-800,000; Or the composite that described fusion device main body is made up of these medical degradable polymeric materials and bioceramic is made; The mass ratio of described medical degradable polymeric material and bioceramic is 3:7-7:3; And described medical degradable polymeric material forms continuous phase; With the formal distribution of microgranule in the composite, the particle diameter of described microgranule is 2-20 μm to described bioceramic.
According in cervical fusion cage of the present invention, described anterior approach fixing head is made up of one or more medical degradable polymeric materials following: polylactic acid, polyglycolic acid and Poly(D,L-lactide-co-glycolide; The molecular weight of described medical degradable polymeric material is 100,000-500,000; Or the composite that described fusion device main body is made up of these medical degradable polymeric materials and bioceramic is made; The mass ratio of described medical degradable polymeric material and bioceramic is 3:7-7:3; And described medical degradable polymeric material forms continuous phase; With the formal distribution of microgranule in the composite, the particle diameter of described microgranule is 2-20 μm to described bioceramic.
Implement cervical fusion cage of the present invention, there is following beneficial effect: the present invention is fixed together by the anterior approach fixing head made by medical degradable material and fusion device main body, whole cervical fusion cage can be fixed on upper hypocentrum, prevent its slippage or slide backward and oppress nervus centralis forward; And both all adopt medical degradable material to make, and can degrade voluntarily after surgery, effectively alleviate the sense of discomfort of patient, it also avoid second operation and take out.
Accompanying drawing explanation
Below in conjunction with drawings and Examples, the invention will be further described, in accompanying drawing:
Fig. 1 is the front view of cervical fusion cage according to the preferred embodiment of the invention;
Fig. 2 is the right view of cervical fusion cage according to the preferred embodiment of the invention;
Fig. 3 is the axonometric chart of cervical fusion cage according to the preferred embodiment of the invention;
Fig. 4 is the front view according to anterior approach fixing head first embodiment in cervical fusion cage of the present invention;
Fig. 5 is the assembling schematic diagram according to anterior approach fixing head in cervical fusion cage of the present invention;
Fig. 6 is the front view according to anterior approach fixing head second embodiment in cervical fusion cage of the present invention.
Detailed description of the invention
In order to make object of the present invention, technical scheme and advantage clearly understand, below in conjunction with drawings and Examples, the present invention is further elaborated.
Refer to Fig. 1 to Fig. 3, be respectively the front view of cervical fusion cage according to the preferred embodiment of the invention, right view and axonometric chart.As shown in the figure, this cervical fusion cage comprises fusion device main body 1 and anterior approach fixing head 2.This fusion device main body 1 and anterior approach fixing head 2 all adopt medical degradable material to make.Fusion device main body 1 is wedge shape low after front height, anterior approach fixing head 2 is positioned at the front end of fusion device main body 1, the middle part of this anterior approach fixing head 2 has at least one first fixing hole 21, for being fixedly connected with the front end of fusion device main body 1 by such as bioabsorbable interference screw 3, the two ends up and down of this anterior approach fixing head 2 also have the second fixing hole 22 respectively, for being fixedly connected with cervical vertebra by such as bioabsorbable interference screw 3.
In the present invention, fusion device main body 1 can be arranged in cervical vertebral space after implanting, play stable, strut and maintain the effect of disc height, and whole cervical fusion cage can be fixed on upper hypocentrum by the anterior approach fixing head 2 be fixedly connected with its front end, prevent its slippage or slide backward and oppress nervus centralis forward.And both all adopt medical degradable material to make, and can degrade voluntarily after surgery, effectively alleviate the sense of discomfort of patient, it also avoid second operation and take out.In addition, due to the medical degradable material that adopts in the present invention and autologous flexible bone modulus close, can not stress shielding be formed in clinical practice, be conducive to intervertebral shape bone osteogenic fusion.
Below the concrete structure of fusion device main body 1 and anterior approach fixing head 2 in cervical fusion cage of the present invention is described respectively.
In the present invention, the bearing definition of fusion device main body 1 is: after implanting, be positioned at patients with cervical front to be connected with anterior approach fixing head 2, to be before this fusion device main body 1 towards the face of esophagus, face towards patient's canalis spinalis is after this fusion device main body 1, left side and the right side of this fusion device main body 1 is respectively towards the left and right Carotid face of patient, face towards patient's skull is the upper surface of this fusion device main body 1, and the face towards patient's thoracic vertebra is the lower surface of this fusion device main body 1.Distance between front-back is the length of this fusion device main body 1, and the distance between left and right side is the width of this fusion device main body 1, and the distance between upper surface and lower surface is the height of this fusion device main body 1.The direction of upper surface and the lower surface line of centres is the axis of this fusion device main body 1.
The size of this fusion device main body 1 and the size of adult's intervertebral space of cervical vertebra match, and its length is 14.0-16.0mm, and width is 12.0-14.0mm, are highly 6.0-9.0mm.Wherein, the height of fusion device main body 1 front portion is a little more than rear portion, and its difference in height is more than 1mm, and the height at the height of wedge shape front portion and rear portion is all in the numerical range of 6.0-9.0mm.In some embodiments of the invention, the dentalation 11 that the degree of depth is 0.3-0.8mm, spacing is 1.5-2.5mm is provided with in the upper surface of this fusion device main body 1 and lower surface.In other embodiments of the present invention, because fusion device main body 1 and anterior approach fixing head 2 are fixed together by bioabsorbable interference screw, fusion device main body 1 can be located at intervertebral well, therefore the upper surface of fusion device main body 1 and lower surface do not need to arrange this dentalation 11, and then simplify the production technology of product, reduce production cost.
In a preferred embodiment of the invention, this fusion device main body 1 is provided with the vertical through hole 12 penetrating upper surface and lower surface.This vertical through hole 12 is roughly arranged along the axis of fusion device main body 1, is preferably center ofthe and the rear end of close fusion device main body 1.This vertical through hole 12 is the cylindrical of diameter 3-6mm or square for length of side 3-6mm, and the edge of this vertical through hole 12 is not less than 3mm to the distance of fusion device main body 1 rear end face.In a preferred embodiment of the invention, this fusion device main body 1 is also provided with and penetrates left and right side and the horizontal through hole 13 be communicated with vertical through hole 12, and this horizontal through hole 13 is the cylindrical of diameter 3-4mm.This vertical through hole 12 and horizontal through hole 13 all can be used for loading autologous bone or other bone-grafting material, participate in the formation of new bone after implanting, and accelerate intervertebral fusion.The Invasive lumbar fusion device that existing degradable biomaterial is made is due to the problem in shape and structural design, effectively can not ensure the stability of its mechanical property, such as bending strength etc., and the size of vertical through hole 12 and horizontal through hole 13 and Position Design in the present invention, effectively ensure that the mechanical strength of fusion device main body 1 meets the demand of operation.
Anterior approach fixing head 2 is connected to the front end of fusion device main body 1 part, its bearing definition is: after implanting, face towards esophageal patient is before this anterior approach fixing head 2, be after this anterior approach fixing head 2 towards patient's canalis spinalis, the face that is connected with the front end of fusion device main body 1, left side and the right side of this anterior approach fixing head 2 is respectively towards the left and right Carotid face of patient, part towards patient's skull is the upper end of this anterior approach fixing head 2, and the part towards patient's thoracic vertebra is the lower end of this anterior approach fixing head 2.Distance between front-back is the thickness of this anterior approach fixing head 2, and the distance between left and right sides is the width of this anterior approach fixing head 2, and upper and lower side is the height of this anterior approach fixing head 2 apart from the distance between 2 farthest.
The height of this anterior approach fixing head 2 is 20.0-28.0mm, and width is 8.0-12.0mm, and thickness is 1.5-3.0mm.In a preferred embodiment of the invention, the two ends up and down of this anterior approach fixing head 2 are circular arc or square.Refer to Fig. 4 and Fig. 5, be respectively the front view according to anterior approach fixing head first embodiment in cervical fusion cage of the present invention and assembling schematic diagram; As shown in the figure, the middle part of this anterior approach fixing head 2 is provided with first fixing hole 21, and upper and lower two ends are also respectively equipped with second fixing hole 22.In the present invention, anterior approach fixing head 2 can be straight plate or bending platy structure, such as, in Fig. 1-3 is straight plate structure, and in Fig. 4-5 is bending platy structure.In operation process, first fusion device main body 1 is inserted cervical intervertebral from front to back, determine the position of anterior approach fixing head 2 again, use bioabsorbable interference screw 3 to fix with the front end of fusion device main body 1 through the first fixing hole 21, will bioabsorbable interference screw 3 be used to fix with the front portion of upper and lower vertebral body through the second fixing hole 22 more subsequently.In other embodiments of the invention, in anterior approach fixing head second embodiment as shown in Figure 6, every one end also can arrange two or the second above fixing hole 22 along short transverse or width respectively.Can also as required after insertion fusion device main body 1 in the present invention, place the autologous bone of one piece of suitable dimension in the front end of fusion device main body 1, then realize through the first fixing hole 21 of anterior approach fixing head 2, this autologous bone and fusion device main body 1 fixing successively by bioabsorbable interference screw 3.The volume of autologous bone in cervical fusion cage can be increased in this way when not affecting mechanical strength and connective stability, contributing to intervertebral shape bone osteogenic fusion.In other preferred embodiments of the present invention, also can in the preoperative anterior approach fixing head 2 and fusion device main body 1 be fixed together, implant together again, can solve like this and locate inaccurate problem in Operation, anterior approach fixing head can ensure the dead ahead being strictly positioned at fusion device main body, can ensure that the implantation depth of fusion device main body is just right simultaneously.
In the present invention, fusion device main body 1 can be made up of one or more medical degradable polymeric materials following: polylactic acid (PLA), polyglycolic acid (PGA), Poly(D,L-lactide-co-glycolide (PLGA) and polycaprolactone (PCL) etc.The molecular weight of these medical degradable polymeric materials is 50,000-800,000.Preferably, when adopting a kind of material in PLA, PGA or PLGA to make, its molecular weight ranges is 200,000-800,000; When adopting pure PCL to make, its molecular weight ranges is 50,000-300,000.The composite that fusion device main body 1 also can adopt above-mentioned medical degradable polymeric material and the bioceramic such as calcium phosphate, hydroxyapatite to form.When fusion device main body 1 uses polymer/biological ceramic composite material to make, the mass ratio of medical degradable polymeric material and bioceramic is 3:7-7:3; And wherein medical degradable polymeric material forms continuous phase, bioceramic is with the formal distribution of microgranule in this composite, and the particle diameter of its microgranule is 2-20 μm.
In the present invention, anterior approach fixing head 2 can be made up of one or more medical degradable polymeric materials following: polylactic acid (PLA), polyglycolic acid (PGA) and Poly(D,L-lactide-co-glycolide (PLGA) etc.The molecular weight of these medical degradable polymeric materials is 100,000-500,000.The composite that anterior approach fixing head 2 also can adopt above-mentioned medical degradable polymeric material and the bioceramic such as calcium phosphate, hydroxyapatite to form.When anterior approach fixing head 2 uses polymer/biological ceramic composite material to make, the mass ratio of medical degradable polymeric material and bioceramic is 3:7-7:3; And wherein medical degradable polymeric material forms continuous phase, bioceramic is with the formal distribution of microgranule in this composite, and the particle diameter of its microgranule is 2-20 μm.
Cervical fusion cage of the present invention, by the design of said structure and material, can reach following degradation time and mechanical strength.Wherein, in the present invention, the degradation time of fusion device main body 1 is 6-24 month.Particularly, after fusion device main body 1 implants 6-12 month starts degraded, and is absorbed by organism metabolism gradually, and the degradable time is 12-24 month.The degradation time of anterior approach fixing head 2 is 3-12 month.Particularly, anterior approach fixing head 2 starts degraded after 3-6 month after implanting, and is absorbed by organism metabolism gradually, and the degradable time is 6-12 month.With regard to mechanical strength, in the present invention, fusion device main body 1 is 80-140MPa along the comprcssive strength of short transverse and aforementioned axial.The bending strength of anterior approach fixing head 2 is 40-70MPa.
In sum, cervical fusion cage of the present invention has the following advantages:
1. anterior approach fixing head 2 degradable being absorbed by organism metabolism after implantation certain hour, thus oppression can not be caused to esophagus and surrounding tissue, the foreign body sensation avoiding causing patient's bottleneck throat long-term and sense of discomfort; Also without the need to being taken out by second operation, alleviating the misery of patient, reducing medical treatment cost;
2. fusion device main body 1 progressively can be degraded along with the growth of autologous patient bone and creeping substitution, and is finally absorbed by organism metabolism, is the osseous tissue of patient self completely, does not have foreign body to retain, thus reach desirable intervertebral fusion effect in intervertebral space;
3. fusion device main body 1 part with same or approximate material composition has similar elastic modelling quantity with anterior approach fixing head 2 part, avoids and uses the too high anterior cervical titanium plate/corrosion resistant plate of elastic modelling quantity and the stress shielding problem brought;
4. anterior approach fixing head 2 and fusion device main body 1 are fixed together by bioabsorbable interference screw 3, and anterior approach fixing head 2 is fixed on upper hypocentrum by bioabsorbable interference screw 3, not only can prevent fusion device main body 1 from deviating from forward, can also effectively prevent fusion device main body 1 from sliding backward and oppressing nervus centralis, traditional anterior cervical titanium plate/corrosion resistant plate does not then possess such function.
embodiment 1
This embodiment is for the preparation of the cervical fusion cage of PLA material.Wherein, fusion device main body 1 is pure Poly-L-lactic acid (PLLA, molecular weight is 800,000) material manufacture; Fusion device main body 1 is of a size of long 14.0mm, wide 12.5mm, and front height is 7.0mm, and rear height is 6.0mm; The upper and lower end face of fusion device main body 1 has that the degree of depth is 0.35mm, spacing is the dentalation of 2.0mm; The center ofthe of fusion device main body 1 is near the cylindrical orthogonal through hole 12 below with diameter 4.6mm, and the center of circle of vertical through hole 12 is 6.3mm to the distance of fusion device main body 1 rear end face.After tested, the fusion device main body 1 of the present embodiment comprcssive strength is vertically 110.6MPa.
Anterior approach fixing head 2 is pure poly-dl-lactide (PDLLA, molecular weight is 300,000) material manufacture; The two ends up and down of anterior approach fixing head 2 are circular arc, and top and bottom are equipped with 1 fixing hole; The height of anterior approach fixing head 2 is 22.0mm, and width is 9.0mm, and thickness is 1.8mm.After tested, the bending strength of the anterior approach fixing head 2 of the present embodiment is 52.7MPa.
The cervical fusion cage of the present embodiment is implanted neck 3/4 intervertebral space of healthy goat, be fixed with polylactic acid screw.Postoperative normal raising, observes the degraded of cervical fusion cage and the bone syncretizing effect of operative site.Result shows: anterior approach fixing head 2 started degraded in 3 months time, degradable when 7 months; Fusion device main body 1 started degraded in 8 months time, degradable when 19 months; Disc height keeps good, and material is degraded gradually along with the growth of autologous bone; After 19 months, intervertebral space is autologous osseous tissue completely, reaches desirable intervertebral fusion.
embodiment 2
This embodiment is for the preparation of the cervical fusion cage of PLA/PCL combined material.Wherein, fusion device main body 1 is pure PCL (molecular weight is 150,000) material manufacture; Fusion device main body 1 is of a size of long 15.0mm, wide 12.0mm, and front height is 8.0mm, and rear height is 7.0mm; The upper and lower end face of fusion device main body 1 has that the degree of depth is 0.5mm, spacing is the dentalation of 2.0mm; The center ofthe of fusion device main body 1 is near the square vertical through hole 12 below with length of side 5.5mm, and the center of vertical through hole 12 is 7.0mm to the distance of fusion device main body 1 rear end face.After tested, the fusion device main body 1 of the present embodiment comprcssive strength is vertically 121.5MPa.
Anterior approach fixing head 2 is pure Poly-L-lactic acid (PLLA, molecular weight is 200,000) material manufacture; The two ends up and down of anterior approach fixing head 2 are square, and top and bottom are equipped with 2 fixing holes side by side in the width direction; The height of anterior approach fixing head 2 is 24.0mm, and width is 12.0mm, and thickness is 2.0mm.After tested, the bending strength of the anterior approach fixing head 2 of the present embodiment is 63.8MPa.
The cervical fusion cage of the present embodiment is implanted neck 3/4 intervertebral space of healthy goat, be fixed with polylactic acid screw.Postoperative normal raising, observes the degraded of cervical fusion cage and the bone syncretizing effect of operative site.Result shows: anterior approach fixing head 2 started degraded in 4.5 months time, degradable when 10.5 months; Fusion device main body 1 started degraded in 12 months time, degradable when 24 months; Disc height keeps good, and material is degraded gradually along with the growth of autologous bone; After 24 months, intervertebral space is autologous osseous tissue completely, reaches desirable intervertebral fusion.
embodiment 3
This embodiment is for the preparation of PLGA/ β-TCP composite and the common cervical fusion cage of PCL/ β-TCP composite.Wherein, fusion device main body 1 is PCL/ β-TCP composite (PCL molecular weight is 17.6 ten thousand, β-TCP particle size distribution is 12.0 ± 2.0 μm) material manufacture, PCL/ β-TCP=6/4 (w/w); Fusion device main body 1 is of a size of long 16.0mm, wide 14.0mm, and front height is 9.0mm, and rear height is 7.5mm; The upper and lower end face of fusion device main body 1 has that the degree of depth is 0.6mm, spacing is the dentalation of 2.2mm; The center ofthe of fusion device main body 1 is near the cylindrical orthogonal through hole 12 below with diameter 6.0mm, and the center of circle of vertical through hole 12 is 8.0mm to the distance of fusion device main body 1 rear end face.After tested, the fusion device main body 1 of the present embodiment comprcssive strength is vertically 137.1MPa.
Anterior approach fixing head 2 is PLGA/ β-TCP composite (PLGA molecular weight is 250,000, β-TCP particle size distribution is 12.0 ± 2.0 μm) material manufacture, PCL/ β-TCP=5/5 (w/w); The two ends up and down of anterior approach fixing head 2 are square, and top and bottom are equipped with 2 fixing holes side by side in the width direction; The height of anterior approach fixing head 2 is 26.0mm, and width is 12.0mm, and thickness is 2.2mm.After tested, anterior approach fixing head 2 bending strength of the present embodiment is 58.3MPa.
The cervical fusion cage of the present embodiment is implanted neck 3/4 intervertebral space of healthy goat, be fixed with polylactic acid screw.Postoperative normal raising, observes the degraded of cervical fusion cage and the bone syncretizing effect of operative site.Result shows: anterior approach fixing head 2 started degraded in 3 months time, degradable when 8 months; Fusion device main body 1 started degraded in 10 months time, degradable when 21 months; Disc height keeps good, and material is degraded gradually along with the growth of autologous bone; After 21 months, intervertebral space is autologous osseous tissue completely, reaches desirable intervertebral fusion.
embodiment 4
This embodiment is for the preparation of the cervical fusion cage of composite.Wherein, taking PLA/HA as the material of fusion device main body 1, take PLA as the material of anterior approach fixing head 2, manufactures the cervical fusion cage that 36 sizes meeting following parameter area are slightly different.
Fusion device main body 1 is PLLA/HA composite (PLLA molecular weight is 800,000, HA particle diameter 10.0 ± 1.0 μm) composite manufacture, PLLA:HA=6:4 (w/w); Fusion device main body 1 is of a size of long 14.0-16.0mm, wide 12.5-13.5mm, high 6.0-8.0mm; The upper and lower end face of fusion device main body 1 has that the degree of depth is 0.35mm, spacing is the dentalation of 2.0mm; The center ofthe of fusion device main body 1 is near the cylindrical orthogonal through hole 21 below with diameter 4.6-5.2mm, and the center of circle of vertical through hole 21 is 6.3-6.6mm to the distance of fusion device main body 1 rear end face.After tested, the fusion device main body 1 of the present embodiment comprcssive strength is vertically 122.8 ± 7.4MPa.
Anterior approach fixing head 2 is pure PDLLA (molecular weight is 350,000) material manufacture; The two ends up and down of anterior approach fixing head 2 are circular arc, and all there is 1 fixing hole top and bottom; The height of anterior approach fixing head 2 is 22.0-26.0mm, and width is 9.0mm, and thickness is 1.8mm.After tested, anterior approach fixing head 2 bending strength of the present embodiment is 53.4 ± 3.1MPa.
The cervical fusion cage of the present embodiment is implanted respectively neck 3/4 intervertebral space in 36 healthy goats (each 18 of male and female, age 2-3 year), be fixed with polylactic acid screw.Postoperative normal raising, observes the degraded of Invasive lumbar fusion device and the bone syncretizing effect of operative site.
Observe and continue 2 years, period does not have the disease that sheep is dead or appearance is relevant to the cervical fusion cage implanted, and all healthy survival of all sheep terminated to the observation period.All there is not slippage forward or backward in the Invasive lumbar fusion device of all sheep et al. Ke.Disc height does not have significant change relative to before implantation Invasive lumbar fusion device.The fusion rate of postoperative 6 months, 12 months and 24 months is respectively 51%, 84% and 96%.The degraded of anterior approach fixing head 2 starts from postoperative 3.2 ± 0.1 months, and the degradable time is postoperative 7.1 ± 0.4 months; The degraded of fusion device main body 1 starts from postoperative 9.1 ± 0.8 months, and the degradable time is postoperative 22.6 ± 1.4 months.Cervical fusion cage in all sheep bodies is all degradable.
The present invention is described according to specific embodiment, but it will be understood by those skilled in the art that when not departing from the scope of the invention, can carry out various change and equivalent replacement.In addition, for adapting to specific occasion or the material of the technology of the present invention, can many amendments be carried out to the present invention and not depart from its protection domain.Therefore, the present invention is not limited to specific embodiment disclosed herein, and comprises all embodiments dropping into claims.
Claims (10)
1. a cervical fusion cage, it is characterized in that, comprise fusion device main body and anterior approach fixing head, described fusion device main body and anterior approach fixing head are made by medical degradable material, described fusion device main body is wedge shape low after front height, have the first fixing hole for being connected with described fusion device body front end in the middle part of described anterior approach fixing head, the described upper and lower two ends of anterior approach fixing head are also respectively equipped with the second fixing hole for being connected with cervical vertebra.
2. cervical fusion cage according to claim 1, is characterized in that, described fusion device principal length is 14.0-16.0mm, and width is 12.0-14.0mm, is highly 6.0-9.0mm; And the difference in height of described fusion device body front end and rear end is more than 1mm.
3. cervical fusion cage according to claim 1, is characterized in that, the upper surface of described fusion device main body and lower surface are provided with that the degree of depth is 0.3-0.8mm, spacing is the dentalation of 1.5-2.5mm.
4. cervical fusion cage according to claim 1, is characterized in that, described fusion device main body is provided with the vertical through hole penetrating described upper surface and lower surface; Described vertical through hole is the cylindrical of diameter 3-6mm or is the square of length of side 3-6mm; And described vertical through hole edge is not less than 3mm to the distance in described fusion device body rear face.
5. cervical fusion cage according to claim 4, is characterized in that, described fusion device main body is also provided with and penetrates left and right side and the horizontal through hole be communicated with described vertical through hole; Described horizontal through hole is the cylindrical of diameter 3-4mm.
6. cervical fusion cage according to claim 1, is characterized in that, the height of described anterior approach fixing head is 20.0-28.0mm, and width is 8.0-12.0mm, and thickness is 1.5-3.0mm; The two ends up and down of described anterior approach fixing head are circular arc or square.
7. cervical fusion cage according to claim 1, is characterized in that, described fusion device main body is 80-140MPa along the comprcssive strength of short transverse; The bending strength of described anterior approach fixing head is 40-70MPa.
8. cervical fusion cage according to claim 1, is characterized in that, the degradation time of described fusion device main body is 6-24 month, and the degradation time of described anterior approach fixing head is 3-12 month.
9. cervical fusion cage according to claim 1, is characterized in that, described fusion device main body is made up of one or more medical degradable polymeric materials following: polylactic acid, polyglycolic acid, Poly(D,L-lactide-co-glycolide and polycaprolactone; The molecular weight of described medical degradable polymeric material is 50,000-800,000; Or
The composite that described fusion device main body is made up of these medical degradable polymeric materials and bioceramic is made; The mass ratio of described medical degradable polymeric material and bioceramic is 3:7-7:3; And described medical degradable polymeric material forms continuous phase; With the formal distribution of microgranule in the composite, the particle diameter of described microgranule is 2-20 μm to described bioceramic.
10. cervical fusion cage according to claim 1, is characterized in that, described anterior approach fixing head is made up of one or more medical degradable polymeric materials following: polylactic acid, polyglycolic acid and Poly(D,L-lactide-co-glycolide; The molecular weight of described medical degradable polymeric material is 100,000-500,000; Or
The composite that described fusion device main body is made up of these medical degradable polymeric materials and bioceramic is made; The mass ratio of described medical degradable polymeric material and bioceramic is 3:7-7:3; And described medical degradable polymeric material forms continuous phase; With the formal distribution of microgranule in the composite, the particle diameter of described microgranule is 2-20 μm to described bioceramic.
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| CN201410635830.1A CN104434346A (en) | 2014-11-12 | 2014-11-12 | Cervical vertebra interbody fusion cage |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN112535555A (en) * | 2020-05-21 | 2021-03-23 | 冯世庆 | Lumbar interbody fusion fixing device |
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