CN1533747A - In vivo absorbable backbone coalescence apparatus - Google Patents
In vivo absorbable backbone coalescence apparatus Download PDFInfo
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- CN1533747A CN1533747A CNA031078982A CN03107898A CN1533747A CN 1533747 A CN1533747 A CN 1533747A CN A031078982 A CNA031078982 A CN A031078982A CN 03107898 A CN03107898 A CN 03107898A CN 1533747 A CN1533747 A CN 1533747A
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- fusion device
- spinal fusion
- lactic acid
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- polylactone
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Abstract
A spinal fusion device absorbable in human body is made of the biodegradable and mechinable high-molecular material able to be disinfected and has a shape of circular tube, spiral thread on its external surface, the cross slots on its top end face, oblique lower end, and several small holes. Its advantages are high elasticity and toughness, easy transplantation, and high stability and absorbability.
Description
Technical field
The present invention relates to a kind of spinal column and be implanted into device, relate in particular to absorbability spinal fusion device in a kind of body.
Background technology
Spinal fusion device is a kind of medical treatment device that is used for internal fixation of spine, also is to treat a kind of spinal column that the important means-spinal fusion surgery of spinal disease uses always at present to be implanted into device.
Spinal fusion surgery was proposed by Hibbs first in 1911 the earliest, and after the theory that has proposed to merge between vertebral body to Mercer in 1936, spinal fusion surgery has obtained very fast development, become one of most important means of treatment orthopaedic disease so far.Autogenous bone graft is still the most desirable embedded material of the spinal fusion of generally acknowledging at present.Although the bone graft fusion of autologous bone transplanting is at present still in wide clinical application, but for limited, the graft donor site complication in bone source, and because thereby the shape and the defect shape problems such as finiteness inconsistent, bone grafting intensity of implantable bone piece are difficult to solve the fusion rate that is difficult to guarantee the section of fusion, cause postoperative to take place easily that plant bone mass displacement, intervertebral space are subsided, bone grafting is absorbed, or form problem such as pseudarthrosis.Although the use of internal fixation can reduce the incidence rate of pseudarthrosis, the use of internal fixation can cause complication to a certain degree equally.
It is lumbar spinal fusion (lumbar interbody fusion using fusion cage) between the vertebral body that carries out of material with rustless steel and titanium alloy that there is the scholar later 1970s.Bagby in 1979 etc. at first are applied to the rustless steel BAK cylindrical with holes of a kind of being called " Basket " the cervical vertebra treatment Wobbler syndrome of horse.Afterwards, kuslich prepared the BAK system in 1988 with titanium alloy, i.e. titanium alloy open column shape body-Cage, because this Cage surface is threaded, and can be from surely in soleplate up and down; The power that struts during implantation can make fibrous ring, front and back longitudinal ligament be in tension state again, thereby helps to stablize Cage, forms " strutting-the compressive tension band " effect, and is through clinic trial, respond well.Because good organization's compatibility of titanium alloy material, acidproof, corrosion-resistant and stronger mechanical strength, " Cage " can be played well to spinal column temporary transient stable, the effect that promotes to merge between vertebral body, reduce complication is provided, so soon by clinical acceptance, and obtained using widely.Yet, because rustless steel and titanium alloy are metal, elastic modelling quantity is far above normal bone tissues (titanium is 10 times of bone), retains for a long time to cause stress shielding in bone, thereby causes implant site to produce osteanabrosis, osteoporosis, the implant site complication that mechanical performance descends such as sink to subsiding.Simultaneously, can cause the release of media such as the generation of macrophage and il-1, interleukin-6, PGE2, tumor necrosis factor by the metal fragment that metal implant produced, thereby influence the activity of skeletonization and osteoclast, finally cause molten bone, cause that implant is loosening.The result of clinical observation shows the sinking of metal Invasive lumbar fusion device Cage, the loosening release that reaches inflammatory mediator, may be the main cause that causes patient's postoperative lumbago and backache.In addition, use rustless steel and titanium alloy metal fusion device after, also can be, and the observation of situation is merged in influence to patient's postoperative owing to the metal material X-ray opaque.
Biodegradable high molecular be a class its strand under physiological environment can rupture automatically, from macromole become micromolecule, never the dissolving become solubilized, finally can be gradually by the material of organism metabolism or absorption.Polylactone class Biodegradable high molecular, as poly-Acetic acid, hydroxy-, bimol. cyclic ester, polylactide, polycaprolactone, and their copolymer or blends natural with other or synthetic high polymer (as polyethers, polyamino acid, poly, chitin, alginate etc.), be the important Biodegradable high molecular of a class.By regulating and control material composition and molecular weight, can guarantee that material reaches certain mechanical strength.Therefore if can then be expected to satisfy simultaneously and can prevent the requirement of complication again with this material preparation BAK for spinal column provides temporary transient stablizing, promote to merge between vertebral body.Owing to have biodegradability with the BAK of this material preparation, the As time goes on new bone BAK of gradually growing into, fusion device self then can constantly degrade, by macromolecule become middle molecule, down to micromolecule; And the final catabolite of poly-Acetic acid, hydroxy-, bimol. cyclic ester and polylactide is glycolic and lactic acid, and they can finally become water by tricarboxylic acid cycle in vivo and carbon dioxide is absorbed or excretes; Polycaprolactone then can be engulfed by phagocyte less than 5000 o'clock being degraded to molecular weight, finally can both disappear in the body and can not stay in the body.Therefore use BAK by polylactone class Biodegradable high molecular and their copolymer or blend preparation, the stress shielding and the metal fragment problem of rustless steel and titanium alloy metal fusion device both can have been avoided, again can be because of its X-ray thoroughly, and do not influence the observation of postoperative.This kind material can synthesize in a large number, also can be processed to the shape identical with defect in addition, is expected to solve the limited for the bone source of autologous bone transplanting, for problems such as bone district complication.
Summary of the invention
The objective of the invention is to disclose absorbability spinal fusion device and preparation method thereof in a kind of body, this fusion device is simple in structure, it is convenient and time-saving to settle during operation; Both can avoid using the existing stress of metal fusion device to block and produce problems such as metal fragment, the patient be can not influence again and X-ray and NMR inspection further accepted, also can avoid limited, the graft donor site complication in bone grafting source of autogenous bone graft simultaneously, and plant bone mass displacement, intervertebral space are subsided, bone grafting is absorbed, or problem such as pseudarthrosis.
Spinal fusion modulator material of the present invention has biodegradability, can be in vivo along with the formation of bone, and himself is constantly degraded, and finally is absorbed and excretes; Or engulfed by phagocyte, therefore finally can both disappear in the body and can not stay in the body.
Spinal fusion device of the present invention is the garden cast, outer wall is threaded, and there is the insertion of cross recess, able to hold device the upper end, and the lower end has the inclined-plane can make things convenient for fusion device to enter the vertebral body defect.Because both certain mechanical strength of tool of spinal fusion modulator material of the present invention has certain elasticity and toughness again, so spinal fusion device can be combined closely with vertebral body, have self-stable function after being screwed into soleplate downwards; The power of strutting when inserting can make the fibrous ring of intervertebral disc, front and back longitudinal ligament be in tension state, and the latter helps to stablize fusion device again, produces " strutting-the compressive tension band " effect.In addition, the dynamic shrinkage of muscle and vertically help lumbar fusion cages to keep stable again from heavy sensation of the whole body.
The physical dimension of spinal fusion device of the present invention has different according to the defect size of vertebral body.In general, the external diameter of fusion device is 5～20mm, and wall thickness is 1～5mm, and length is 5～20mm, and pitch is 0.5～3.0mm.
Spinal fusion device of the present invention has the aperture of some on the tube wall of garden cast, be beneficial to growing into of osteocyte and entering of body fluid and nutrient substance.The aperture of aperture is 1～3mm, and quantity is 6～20, and is different and different according to the physical dimension of fusion device.
Spinal fusion device of the present invention can adopt the method machine-shaping of extrusion molding, machining or mold pressing.Adopt the sterilization of radiation or oxirane vapor sterilization.
Spinal fusion device of the present invention is by having biological degradability, sterilizability and biodegradated polymer materal preparation that can processability.Described biodegradable polymer is meant the aliphatic poly lactone, as polyglycolic acid (PGA), poly (l-lactic acid) (PLLA), poly-DL-lactic acid (PDLLA), polycaprolactone (PCL); Copolymer between lactone, as copolymerization (L-lactic acid/DL-lactic acid) (PLLA-co-PDLLA), copolymerization (lactic acid/glycolic) bipolymer (PLGA), copolymerization (lactic acid/caprolactone) bipolymer (PLC), copolymerization (glycolic/lactic acid/caprolactone) terpolymer (PGLC); Lactone is with the copolymer of polyethers, as polycaprolactone/polyether block copolymer (PCE), polycaprolactone/polyethers/polylactic acid terpolymer (PCEL), polylactic acid/polyether bipolymer (PLE); The copolymer of the same aminoacid of lactone, maleic acid; And the polylactone family macromolecule is with natural macromolecule, as the copolymer of chitin, alginate etc.; Between various polylactones or the blend between the same chitin of polylactone, alginate, and the blend of inorganic material such as the same hydroxyapatite of polylactone family macromolecule, Corallium Japonicum Kishinouye, tricalcium phosphate.Do not have strict proportion requirement between the blend of above-mentioned biodegradable polymer, need only require to select the ratio of blend to get final product according to the intensity and the degradation time of operative site material.That is, when needing fusion device degraded slow, the slower polymeric biomaterial or strengthen the ratio of this material of then can selecting to degrade, otherwise the material faster or strengthen the ratio of this material of selecting to degrade.
The characteristics of spinal fusion device of the present invention are to contain infection and cancer therapy drug in the fusion device material.Described anti-infectives is that streptomycin, penicillin, gentamycin, mitomycin, erythromycin, metronidazole, norfloxacin, 5-fluorouracil, paclitaxel, thunder are sent mycin.
Description of drawings
Fig. 1 is the structural representation of spinal fusion device of the present invention.
The specific embodiment
Embodiment 1:
As shown in Figure 1, be the structural representation of spinal fusion device of the present invention, material is a poly (l-lactic acid).This spinal fusion device 1 is cylindric, is that 300,000 PLLA machining forms by molecular weight, and outer wall is threaded 2, and there is cross recess 3 upper end, and for the insertion of setting device, the fusion device lower end has the inclined-plane 4 of a lead angle shape can make things convenient for fusion device to enter the vertebral body defect.The fusion device external diameter is 10mm, and wall thickness is 2mm, and height is 12mm, and outer wall has the screw thread 2 that pitch is 2mm, the circular hole 5 that it is 1.5mm that its perisporium is distributed with 10 apertures.
The male little tail of the body weight 45Kg sheep that trembles with fear, right arm reclining, sterilization, drape.At the other camber otch of the left side of sheep 12 rib spinal columns, cut skin, subcutaneous tissue and muscular fascia successively, then cut obliquus externus abdominis m. and rectus abdominis m. to peritoneum, cut off the 12nd rib, passivity is separated to the psoas major leading edge, separates the vertebral body that psoas major exposes the rear, the sections tremulous pulse of ligation vertebral body.Bore an aperture with trepan in breast 12 waists 1 gap, empty intercalated disc and little broken bone after, adopt setting device to settle fusion device, fusion device is placed in breast 12 waists 1 gap of sheep, again the rib of cutting off is shredded the hole of putting into fusion device central authorities, compress slightly, the layer-by-layer suture otch.Postoperative fasting 6 hours gives intramuscular injection 2,400,000 unit penicillins twice at postoperative three day every day; Observe wound, and use the povidone iodine clean wound.
The result shows: fusion device has the favorable tissue compatibility, does not see the tissue necrosis phenomenon that implant site is not seen rejection phenomenon.Mirror is observed down: have a large amount of osseous tissues to generate, do not have fibrous membrane around the fusion device and form, also do not have macrophage and foreign-body giant cell and granulation tissue, do not see various inflammatory cells.Iconography shows: postoperative fusion device part degraded in 6 months, osseous tissue are grown in the fusion device, osseous tissue density is passed in time and obviously increase, and osseous tissue passes in the aperture that merges on the wall, the fusion device of growing into, and the inside and outside osseous tissue of fusion device is linked to each other; Remaining fusion device combine tight with osseous tissue and.The disc height of postoperative fusion in 6 months sections is not seen significant change, and the mechanical strength that fusion device is stronger is described, can play effective supporting to the intervertebral space that merges sections.Before fusion device absorbs, CT and nuclear-magnetism inspection there is not influence.
Embodiment 2:
With embodiment 1 structure, but fusion device is that 400,000 PDLLA machining forms by molecular weight, and external diameter is 15mm, and wall thickness is 3mm, and height is 15mm, and outer wall has the screw thread that pitch is 2.5mm, and its perisporium has the hole, garden that to be evenly distributed with 14 apertures be 2.0mm.Undergo surgery with embodiment 1 same operation method then and observe surgical outcome.Observed result shows that surgical effect is identical with embodiment 1.
Embodiment 3:
With embodiment 1 structure,, fusion device processes with the method for mold pressing but being the blend of 1: 1 PLLA (molecular weight is 300,000) and PDLLA (molecular weight is 400,000) by weight ratio.The fusion device external diameter is 20mm, and wall thickness is 4mm, and height is 20mm, and outer wall has the screw thread that pitch is 2.5mm, and its perisporium has the hole, garden that to be evenly distributed with 18 apertures be 2.0mm.Undergo surgery with embodiment 1 same operation method then and observe surgical outcome.Observed result shows that surgical effect is identical with embodiment 1.
Embodiment 4:
The material of fusion device, structure and size are identical with embodiment 1, but are processed by extrusion molding.Undergo surgery with embodiment 1 same operation method then and observe surgical outcome.Observed result shows that surgical effect is identical with embodiment 1.
Embodiment 5:
The material of fusion device, structure and size are identical with embodiment 1, are processed by extrusion molding, but contain 1 milligram of 5-fluorouracil.Undergo surgery with embodiment 1 same operation method then and observe surgical outcome.Observed result shows that surgical effect is identical with embodiment 1.
Embodiment 6:
The material of fusion device, structure and size are identical with embodiment 1, are processed by extrusion molding.But contain 1 milligram of mitomycin.Undergo surgery with embodiment 1 same operation method then and observe surgical outcome.Observed result shows that surgical effect is identical with embodiment 1.
Embodiment 7:
The fusion device material is the mixture that contains the PLLA (molecular weight is 300,000) of 10% (weight) calcium phosphate, and structure is identical with embodiment 1 with size, is processed by extrusion molding.But contain 1 milligram of gentamycin.Undergo surgery with embodiment 1 same operation method then and observe surgical outcome.Observed result shows that surgical effect is identical with embodiment 1.
Reference examples 1:
With embodiment 1 structure and size, but with titanium alloy (model is Ti-6A1-4V) preparation fusion device, undergo surgery with embodiment 1 same operation method then and observe surgical outcome.
Observed result shows: titanium fusion device X-ray opaque, long-term existence and not changing in vivo.
Claims (8)
1, absorbability spinal fusion device in a kind of body is prepared from by having biological degradability, sterilizability and biodegradated polymer materal that can processability, is tubular type, and outer wall is threaded, and there are cross recess, the insertion of able to hold device in its upper end; There is the inclined-plane lower end, can make things convenient for fusion device to enter the vertebral body defect;
The physical dimension of described BAK is decided according to the defect size of vertebral body;
Have some apertures on the tube wall of described BAK, be beneficial to growing into of osteocyte and entering of body fluid and nutrient substance, the quantity of this aperture is decided according to the physical dimension of fusion device;
Because the flexible and toughness of spinal fusion utensil, can combine closely with vertebral body, have self-stable function after being screwed into soleplate downwards; The power of strutting when inserting can make the fibrous ring of intervertebral disc, front and back longitudinal ligament be in tension state, and the latter helps to stablize fusion device again, produces " strutting-the compressive tension band " effect; Simultaneously, the dynamic shrinkage of muscle and vertically help lumbar fusion cages to keep stable again from heavy sensation of the whole body.
2, spinal fusion device as claimed in claim 1, it is characterized in that, described biodegradated polymer materal be copolymer, lactone between aliphatic poly lactone, lactone with the same aminoacid of copolymer, lactone of polyethers, the copolymer of maleic acid, and the polylactone family macromolecule is with between natural macromolecule, various polylactone or the blend of the blend between the same chitin of polylactone, alginate or the same hydroxyapatite of polylactone, Corallium Japonicum Kishinouye, tricalcium phosphate.
3, spinal fusion device as claimed in claim 1 or 2, it is characterized in that described biodegradated polymer materal is one or two or more kinds the blend in polyglycolic acid, poly (l-lactic acid), poly-DL-lactic acid, polycaprolactone, copolymerization (L-lactic acid/DL-lactic acid), copolymerization (lactic acid/glycolic) bipolymer, copolymerization (lactic acid/caprolactone) bipolymer, copolymerization (glycolic/lactic acid/caprolactone) terpolymer, polycaprolactone/polyether block copolymer, polycaprolactone/polyethers/polylactic acid terpolymer, the polylactic acid/polyether bipolymer.
4, spinal fusion device as claimed in claim 1 is characterized in that, contains infection and cancer therapy drug in the described fusion device material.
5, spinal fusion device as claimed in claim 4 is characterized in that, described medicine is that streptomycin, penicillin, gentamycin, mitomycin, erythromycin, metronidazole, norfloxacin, 5-fluorouracil, paclitaxel or thunder are sent mycin.
6, spinal fusion device as claimed in claim 1 is characterized in that, the external diameter of described fusion organ pipe is 5～20mm, and wall thickness is 1～5mm, and length is 5～20mm, and pitch is 0.5～3.0mm.
7, BAK as claimed in claim 1 is characterized in that, the aperture of aperture is 1～3mm on the described tube wall, and quantity is 6-20.
8, a kind of method for preparing above-mentioned spinal fusion device adopts the method machine-shaping of extrusion molding, machining or mold pressing; Adopt the sterilization of radiation or oxirane vapor sterilization.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03107898 CN1239129C (en) | 2003-04-01 | 2003-04-01 | In vivo absorbable backbone coalescence apparatus |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03107898 CN1239129C (en) | 2003-04-01 | 2003-04-01 | In vivo absorbable backbone coalescence apparatus |
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| CN1533747A true CN1533747A (en) | 2004-10-06 |
| CN1239129C CN1239129C (en) | 2006-02-01 |
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| CN 03107898 Expired - Fee Related CN1239129C (en) | 2003-04-01 | 2003-04-01 | In vivo absorbable backbone coalescence apparatus |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102085387A (en) * | 2010-12-20 | 2011-06-08 | 苏州奥芮济医疗科技有限公司 | In vivo absorbable metal intervertebral fusion cage |
| CN101002703B (en) * | 2007-01-23 | 2012-06-13 | 成都军区昆明总医院 | Absorbable intrapyramidal stent |
| CN104758095A (en) * | 2015-04-16 | 2015-07-08 | 倪文飞 | Oblique interbody fusion cage |
| CN112998917A (en) * | 2021-02-19 | 2021-06-22 | 陈赞 | Lower cervical vertebra lateral mass prosthesis |
-
2003
- 2003-04-01 CN CN 03107898 patent/CN1239129C/en not_active Expired - Fee Related
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101002703B (en) * | 2007-01-23 | 2012-06-13 | 成都军区昆明总医院 | Absorbable intrapyramidal stent |
| CN102085387A (en) * | 2010-12-20 | 2011-06-08 | 苏州奥芮济医疗科技有限公司 | In vivo absorbable metal intervertebral fusion cage |
| CN104758095A (en) * | 2015-04-16 | 2015-07-08 | 倪文飞 | Oblique interbody fusion cage |
| CN104758095B (en) * | 2015-04-16 | 2016-08-31 | 倪文飞 | A kind of oblique Invasive lumbar fusion device |
| CN112998917A (en) * | 2021-02-19 | 2021-06-22 | 陈赞 | Lower cervical vertebra lateral mass prosthesis |
| CN112998917B (en) * | 2021-02-19 | 2024-05-28 | 首都医科大学宣武医院 | Lower cervical vertebra side block prosthesis |
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| Publication number | Publication date |
|---|---|
| CN1239129C (en) | 2006-02-01 |
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