A kind of bone anchoring device by degradable hone lamella and the combination of non-degradable nail
Technical field
The present invention relates to orthopedic medical device, particularly a kind of bone anchoring device by degradable hone lamella and the combination of non-degradable nail.
Background technology
At present, clinical is mainly metal material for material fixing in bone, as internal fixation plate, screw, rod and intramedullary needle etc.Reason is that metal material has good mechanical property, can realize early stage strong fixing, especially load-bearing bone, and curative effect is reliable, is accepted.But because mechanical property is not mated, metal internal fixation material elastic modelling quantity is that human body compact bone is as the 10-20 of long bone, femur times, and mechanical property can not change with knitting process dynamics, there is " stress-shielding effect " medically, cause osteoporosis or self bone deterioration, affect the intensity after knitting and need second operation to remove, increase the burden on patient's economy, psychology and health, and because becoming flexible and deteriorating of metal inside-fixture causes the local phenomenon such as inflammatory reaction and tissue necrosis.
Magnesium alloy bone immobilization material is a kind of new medical material, and it can substitute the bone immobilizing materials such as the steel nail in traditional medicine.Meet most in theory fracture fixing requirement biology, use high-intensity degradable absorbent material to make bone internal fixation material, can realize in early days strong fixing in fracture, along with self symphysis, intensity, the rigidity of degradation material constantly decay, its load can progressively forward in area of new bone, meets union of fracture power
The requirement of learning, has overcome stress shielding, has improved the repairing effect of self bone, and has overcome the various drawbacks of conventional metals internal fixation material without the advantages such as taking-up of again performing the operation.Utilize magnesium alloy corrodible degraded and the nontoxic characteristic of catabolite in human body simultaneously, after skeleton heals substantially, bone fixation means can be degraded into nontoxic product, and excrete the painful and burden of having avoided patient's second operation to take out the body and mind of bone fixture and bring economically through human recycle system.
But, the problem that magnesium alloy faces is at present that corrosion degradation rate is too fast, therefore cause the quick decay of mechanical property, can not match with the speed of knitting, before skeleton heals completely, can not keep enough intensity, can there is fast degradation in magnesium alloy nail particularly, especially the degradation rate of threaded portion is faster, threaded portion, because degraded becomes gently, may cause the fastening force of bone screw to decline, thereby causes the inefficacy of whole bone fixation system.
Summary of the invention
The object of the invention is the problem for above-mentioned existence, a kind of bone anchoring device by degradable hone lamella and the combination of non-degradable nail is provided, this bone anchoring device is simple in structure, easy to implement, degradable hone lamella in vivo corrodible degraded and catabolite nontoxic, can get rid of by metabolism external, the secondary insult of avoiding second operation to bring, non-degraded bone screw can guarantee the bond strength between bone screw and hone lamella.
Technical scheme of the present invention:
A kind of bone anchoring device by degradable hone lamella and the combination of non-degradable nail, be made up of hone lamella, nail and nail jacket, hone lamella upper surface is plane, and hone lamella lower surface mates with the appearance profile of fracture, hone lamella is provided with circular hole, and hone lamella adopts degradation material preparation; Nail is bolt structure, adopts the preparation of non-degradable material; Nail jacket is cylinder, and cylinder upper end is provided with cap and joins with hone lamella upper surface, and lower end is arranged with two swollen grooves, and cylinder is provided with center screw and coordinates with nail, and cylindrical thickness is identical with hone lamella thickness, and nail jacket adopts polylactic acid preparation; Circular hole on nail jacket cylinder and hone lamella closely cooperates, and nail is fixedly connected with fracture through the cylindrical center screw of nail jacket, and the outer support of two swollen grooves by nail jacket lower end is simultaneously fixed nail jacket and hone lamella swelling.
The described degradation material of preparing hone lamella is magnesium metal or magnesium alloy, alloying element in magnesium alloy is one or more arbitrary proportion mixture in one or more and rare earth element y, Nd and the Gd in Zn, Ca, Mn, Zr, Sn, Si and Sr, wherein the mass percentage content of alloying element is: Zn 1-6%, Ca 0.2-1%, Mn 0.2-1.5%, Zr 0.2-1%, Sn0.5-5%, Si0.5-5%, Sr 0.5-5%, rare earth element 0.2-3%.
The described non-degradable material of preparing nail is rustless steel, titanium or cobalt alloy.
Described nail sheath material is polylactic acid-based material, and its molecular weight is more than 100,000.
Advantage of the present invention is: the bone anchoring device that adopts degradable hone lamella and the combination of non-degraded nail, hone lamella adopts magnesium or magnesium alloy preparation, because density and the mechanical property of magnesium or magnesium alloy and bone are close, " stress shielding " effect that can avoid traditional bone bone fixation strip, in addition magnesium alloy in vivo corrodible degraded and catabolite nontoxic, can get rid of by metabolism external, the secondary insult of avoiding second operation to bring; Adopt non-degraded metal material to manufacture nail, can avoid, because the degrade nail constant intensity decline that causes of threaded portion is too fast, guaranteeing the constant intensity in knitting process; The nail jacket that adopts degradable poly lactate material to make, be placed between nail and hone lamella, can avoid direct contact of material of two kinds of Different electrodes current potentials of nail and hone lamella and the cell reaction that causes and cause quick corrosion degraded, guarantee the bond strength between nail and hone lamella.
Accompanying drawing explanation
Accompanying drawing 1 is this bone anchoring device structural representation.
In figure: 1. the swollen groove of hone lamella 2. nail 3. nail jacket 4. circular hole 5. cap 6.
7. center screw.
The specific embodiment
Embodiment:
A kind of bone anchoring device by degradable hone lamella and the combination of non-degradable nail, as shown in Figure 1, formed by hone lamella 1, nail 2 and nail jacket 3, hone lamella 1 upper surface is plane, lower surface mates with the appearance profile of cortex fracture, hone lamella 1 is provided with circular hole 4, and hone lamella 1 adopts degradation material preparation; Nail 2 is bolt structure, adopts the preparation of non-degradable material; Nail jacket 3 is cylinder, cylinder upper end is provided with cap 5 and joins with hone lamella 1 upper surface, and lower end is arranged with two swollen grooves 6, and cylinder is provided with center screw 7 and coordinates with nail 2, cylindrical thickness is identical with hone lamella thickness, and nail jacket 3 adopts polylactic acid preparation; Circular hole 4 on nail jacket 3 cylinders and hone lamella 1 closely cooperates, and nail 2 is fixedly connected with fracture through the cylindrical center screw 7 of nail jacket 3, and the outer support of two swollen grooves 6 by nail jacket 3 lower ends is simultaneously fixed nail jacket 3 and hone lamella 1 swelling.
In this embodiment, be the fixture for cortical bone, the degradation material of preparing hone lamella is magnesium alloy, and the alloying element in magnesium alloy is Zn, Ca, Zr, and wherein the mass percentage content of alloying element is: Zn 3%, Ca 0.3%, Zr 0.5%, and surplus is magnesium; Hone lamella standard thickness is 4mm.Nail material is pure titanium, and specification is M3, and length is 30 ㎜.Nail sheath material is the poly-Poly-L-lactic acid class of PLLA, molecular weight 400,000, and its external diameter is that 4mm, internal diameter M3, thickness are 4.5 ㎜, nail quantity is 4.
Adopt goat to carry out zoopery, this bone anchoring device process certain hour, knitting, hone lamella absorbs, and pure titanium bone nail can take out by Minimally Invasive Surgery (also can not take out), and result of use is good.