CN101283922A - Biological and adsorbable bone internal fixation implantation instrument - Google Patents
Biological and adsorbable bone internal fixation implantation instrument Download PDFInfo
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- CN101283922A CN101283922A CNA200810011500XA CN200810011500A CN101283922A CN 101283922 A CN101283922 A CN 101283922A CN A200810011500X A CNA200810011500X A CN A200810011500XA CN 200810011500 A CN200810011500 A CN 200810011500A CN 101283922 A CN101283922 A CN 101283922A
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Abstract
The invention relates to a bone implanting and internal fixation appliance with bioactivity and absorbability, which belongs to the field of bio-medical appliances, particularly to the field of medical appliances used for bone wound surgery, reparative and reconstructive surgery and plastic and cosmetic surgery. The appliance includes bone nails and a bone plate made of magnesium and the alloy thereof with bioactivity and absorbability. The bone implanting and internal fixation appliance is a bone internal fixation device, which comprises a blade plate and matched screws, intramedullary nails, a fracture and dislocation fixing device of vertebral column, bone nails or screws having individual fixation effect, wherein the bone internal fixation device is made of magnesium and the alloy thereof with bioactivity and absorbability. The bone internal fixation device can solve the problem in bioactivity of prior bone internal fixation device and promote healing the tissue where the device in implanted. The device also includes a protection layer prepared on the surface of the internal fixation device for controlling the degradation rate of magnesium alloy and the dissolution rate of magnesium ions, thus controlling the bioactivity and the absorption speed of the magnesium alloy device in an organism.
Description
Technical field
The present invention relates to orthopedic fixation device spare in the medical apparatus and instruments, belong to the biologic medical instrument field, be specially adapted to bone wound surgery, reconstruction surgery, shaping and beauty medical instruments field; Be specially a kind of biological and adsorbable bone internal fixation implantation instrument, it is by the magnesium metal of biologically active and absorbability and prepared nail, the hone lamella medical apparatus and instruments of alloy thereof.
Background technology
Biological activity is to promote cytoactive or the regenerated performance of new organization, is an important indicator in the bone implanting appliance.The bone implanting appliance of biologically active after the implantable bioartificial body, can promote osteoblastic propagation, differentiation on every side, accelerates the regeneration of cambium, reduces the healing time of both injured bones tissue; Simultaneously can form chemical bond and combine or be called synosteosis, make institute's implantation instrument combine with osseous tissue firmly, the increase success rate of operation with surrounding tissue.
Clinical applied biological activity internal fixation device spare is mainly the titanium alloy internal fixation device through surface-active-treatment at present, and it mainly relies on the employing prepared biological activity hydroxyapatite of distinct methods and shows biological activity.Realize high molecular bioactivation though also have at present by blend, surface adsorption or coating etc., and adopt copolymerization, crosslinked, finishing etc., give the macromolecular material biological activity by changing polymer macromolecule or surface texture, but because its technology unstability, present clinical the application can absorb the high-molecular bone immobilising device and still not possess biological activity.Simultaneously, (be difficult to satisfy clinical requirement as β-TCP) and the mechanical property of bioactivity glass and processability, nail, the hone lamella developed of two class bioactive materials do not have clinical practice as yet thus because bioactive ceramics.
Magnesium is mammal and human trace elements necessary, plays an important role in human body.When magnesium ion concentration is controlled within limits, not only can not produce cytotoxic effect; On the contrary, can promote the propagation and the differentiation of chondrocyte, help cartilage and form.After magnesium alloy implanted, the surface had phosphate to generate, and new bone formation is arranged between phosphate and osseous tissue.Along with the magnesium alloy prolongation of implantation time, phosphate layer constantly changes to new bone tissue, and so new bone is just grown on the magnesium alloy implant.Implanting the comparative study discovery of testing with titanium alloy, there are a large amount of osteoblast and freshman bone tissue around the magnesium alloy implant, a spot of osteoblast and freshman bone tissue are then only arranged around the titanium alloy implant, illustrate that magnesium alloy has more excellent biological activity than titanium alloy, can promote the healing of impaired bones tissue, improve the therapeutic effect of internal fixation device spare.
Magnesium alloy is can absorb embedded material in a kind of body, compares with existing absorbable material, has better mechanical property and biological activity.With biological active titanium alloy phase ratio, magnesium alloy has excellent bio-absorbable performance; Simultaneously, titanium alloy costs an arm and a leg, and China produces magnesium big country, magnesium mineral products amount is abundant, and the magnesium alloy price is much lower than titanium alloy and degradable high polymer material, so the magnesium alloy implant devices has great advantage on price, can reduce the price of implant devices significantly, reduce patient's financial burden.At present, yet there are no the biological activity that utilizes magnesium alloy and the bone internal fixation implantation instrument that designs.
Summary of the invention
It is fixing low or do not possess bioactive problem with adsorbable bone internal fixation product biological activity that the present invention is intended to solve present bone, proposed a kind of Absorbale magnesium alloy bone internal fixation implantation instrument of biologically active.
Technical scheme of the present invention is:
A kind of biological and adsorbable bone internal fixation implantation instrument, this bone internal fixation implantation instrument is an internal fixation device spare, comprise blade plate and supporting screw, intramedullary pin, fracture dislocation of spine fixation device, spicule or play the screw of fixation separately, internal fixation device spare is made by the magnesium metal and the alloy thereof of biologically active and absorbability.
Described magnesium alloy is: the alloy system that magnalium series alloy, magnesium manganese series alloy, magnesium zinc series alloy, magnesium zirconium series alloy, magnesium rare earth metal alloy, magnesium lithium series alloy, magnesium calcium series alloy or magnesium silver series alloy etc. are different a kind of or the ternary system or the polynary system magnesium alloy that are formed by these system combinations.
Related magnesium alloy comprises that mainly magnalium series (mainly comprises Mg-Al-Zn except that binary system, Mg-Al-Mn, Mg-Al-Si, four ternary systems of Mg-Al-RE and other multicomponent systems, alloy representative such as AZ31, AZ61, AM60, AM50, AE21, AS21 etc., wherein the aluminum weight content requires≤10%, Zn, Mn, Si and/or RE weight content≤5%); Magnesium manganese series (mainly be binary Mg-0.1～2.5%Mn and add elementary composition ternary system or polynary systems such as a small amount of rare earth, calcium, zinc, represent alloy such as domestic trade mark MB1 and MB8); Magnesium zinc series (except that binary system, mainly comprising Mg-Zn-Zr and Mg-Zn-Cu series, alloy representative such as ZK21, ZK60, ZC62 etc.); Magnesium zirconium series (mainly be binary Mg-0.1～1%Zr and add elementary composition ternary system or polynary systems such as a small amount of rare earth, zinc, represent alloy such as K1A etc.); Magnesium rare earth metal (mainly being elementary composition ternary system or polynary systems such as binary Mg-0.1～5%RE and interpolation small amount of aluminum, zirconium, calcium, zinc); Magnesium lithium series (mainly be binary Mg-1～15%Li and elementary composition ternary system or polynary systems such as interpolation small amount of aluminum, rare earth, zinc and silicon, represent alloy such as LA91, LAZ933 etc.); Magnesium calcium series (mainly be binary Mg-0.1～10%Ca and add elementary composition ternary system or polynary systems such as a small amount of rare earth, zirconium, zinc); The alloy system that magnesium silver series (mainly be binary Mg-0.1～12%Ag and add elementary composition ternary system or polynary systems such as a small amount of rare earth, zirconium, zinc, represent alloy such as QE22 etc.) etc. are different a kind of or the ternary system and the polynary system magnesium alloy that form by these system combinations.
Among the present invention, internal fixation device spare comprise blade plate and supporting screw, intramedullary pin, fracture dislocation of spine fixation device, spicule with or play the screw of fixation separately.
Among the present invention, internal fixation blade plate device places bone surface with blade plate, by screw fracture site is connected, and reaches the reduction of the fracture, fixing, thereby promotes the purpose of healing.According to different fracture sites and needs, comprise pressurization hone lamella (being mainly used in long bone shaft fracture), rebuild hone lamella (being used for pelvis, distal humerus, clavicle or outer fracture of ankle etc.), privileged sites hone lamella (having the femur ankle to support that hone lamella, calcaneus and toe (finger) bone blade plate, repair of cranial defects hone lamella, the facial blade plate of jaw or defect repair hone lamella are supported in the outside in hone lamella, the tibial plateau outside or the far-end) or special shape hone lamella (S shape, directly the special-shaped blade plate of shape, arc, L shaped, T shape, Y shape, trilobal, X-shaped, I-shaped hone lamella or other special requirements).
Among the present invention, intramedullary pin is to be used in the far-end and near-end pulp cavity of implantable bone, reach fracture site connection, reset and fixing, but comprise single nail, many nails, strong intramedullary pin or tropism intramedullary pins.
Among the present invention, the fracture dislocation of spine fixation device is to utilize tension band, support, neutralization, rectification and lag screw principle, purpose provides adequate stability, keep the complete of a motion segment, and physiological three dimensional form of whole spinal column and balance, equipment comprises hone lamella, hold-down bars, screw, hook or steel wire etc.
Among the present invention, spicule is used for fixing, the bone traction of brothers' short tubular bone.
Among the present invention, nail is mainly used in the internal fixation of supporting hone lamella, also can be used as pulling force nail, an interface nail fixation separately, comprise and matching used screw of hone lamella and independent lag screw or the interference screw that plays fixation, be divided into self thread-cutting screw or non-self thread-cutting screw, and os integumentale screw or cancellous bone screw.Os integumentale screw is the full thread nail, and cancellous bone screw divides screw rod and screw thread two parts.
Among the present invention, biological activity magnesium alloy bone immobilising device surface can prepare one deck overcoat by ion implantation, thermal spraying, ion plating, sputter, chemical vapour deposition (CVD), laser melting coating, plasma technique, electrochemical method or biochemical method, the degradation speed of control magnesium alloy and the dissolution rate of magnesium ion, and portability bioactie agent, further improve the biological activity between itself and the organism, thus control magnesium alloy device biological activity and infiltration rate in vivo; Overcoat thickness is 0.1-200 μ m, and overcoat is hydroxyapatite (HA) coating, bata-tricalcium phosphate (β-TCP) coating, magnesium oxide coating, fluorine-containing overcoat or phosphorous overcoat.
Characteristics of the present invention are:
1. biological activity.The present invention utilizes the biological activity characteristics of the excellence of magnesium alloy, make that promptly there be Ca-P layer deposition the short period to designed internal fixation device spare in vivo, and, around implant devices, form freshman bone tissue with the prolongation of implanting the time, promote the healing of damaged part.
2. controlled degradation.The present invention is fully in conjunction with the advantage of degradable magnesium alloy and surface modification, select and optimize surface reforming layer according to the military service phase needs of internal fixation device spare, control its early stage degradation process, make the degraded of the early stage under arms slowly homogeneous corrosion of blade plate, avoid local corrosion phenomenons such as spot corrosion, guarantee the blade plate excellent mechanical property; Fast and safely degrade at degraded later stage (being that implant is near designing military service during the phase) magnesium alloy materials.
3. elastic modelling quantity is low.Relative conventional metals internal fixation device spare, the degradable magnesium alloy material has density and the elastic modelling quantity approaching with people's bone.The density of magnesium alloy is 1.74g/cm
3About, with the Compact bone density (1.75g/cm of people's bone
3) very approaching, the elastic modelling quantity of magnesium alloy is about 45GPa, about the elastic modelling quantity 20GPa near people's bone, can avoid stress-shielding effect as the bone fixture.
4. safe, practical property is good.Magnesium is the macroelement that is only second to calcium, sodium and potassium in the human body, and everyone the daily requirement amount of being grown up is greater than 350mg, and it participates in a series of metabolic processes in the body.Finally be corroded under the physiological environment in vivo degraded and absorbed or metabolism of degradable magnesium and magnesium alloy blade plate and bone screw by body, its catabolite mainly is the magnesium ion of needed by human body, magnesium is the needed by human body macroelement, and contained other alloying element contents are all within the bio-medical scope; Therefore, it is safe adopting degradable magnesium alloy blade plate of the present invention and bone screw, has very big advantage and application prospect.
5. price is low.China produces magnesium big country, and magnesium mineral products amount is abundant, and the magnesium alloy price is much lower than titanium alloy and degradable high polymer material, so the magnesium alloy implant devices has great advantage on price, can reduce the price of implant devices significantly, reduces patient's financial burden.
6. applied widely.The present invention is applicable in the human or animal body by the prepared blade plate of the magnesium alloy of biologically active and absorbability and supporting screw, intramedullary pin, fracture dislocation of spine fixation device, spicule and the screw that plays fixation separately, can promotes the organization healing of device implant site.Simultaneously, also be included in described internal fixation device surface preparation one deck overcoat, the degradation speed of control magnesium alloy and the dissolution rate of magnesium ion, thereby control magnesium alloy device biological activity and infiltration rate in vivo.
Description of drawings
Fig. 1 is the designed internal fixation device spare structural representation of the embodiment of the invention 1.Among the figure, 1 blade plate; 2 holes; 3 bone screw.
Fig. 2 is the biological activity device of employing the present invention preparation soaks 3 days rear surface deposition Ca-P layers in simulated body fluid an X-ray spectra.
Fig. 3-Figure 11 is an embodiment of the invention structural representation.Wherein, Fig. 3 is L shaped blade plate; Fig. 4 is a T shape blade plate; Fig. 5 is the trilobal blade plate; Fig. 6 is a Y shape blade plate; Fig. 7 is special-shaped blade plate; Fig. 8 is the arc blade plate; Fig. 9 is a S shape blade plate; Figure 10 is special-shaped blade plate; Figure 11 is special-shaped blade plate.Among the figure, 1 blade plate; 2 holes.
Figure 12 is the structural representation of nail in the embodiment of the invention.
Figure 13 adopts the biological activity device that has β-TCP coating of the present invention's preparation to soak in simulated body fluid 1 day, the new scanned photograph that forms osteoid apatite in surface.
The specific embodiment
As shown in Figure 1, adopt AZ31B (magnesium-aluminum system) magnesium alloy to be made into blade plate 1 and bone screw 3, hone lamella 1 is shaped as straight shape plate, and bone screw 3 is by hole 2 fixation bone fracture plate 1.As shown in Figure 2, soaked 3 days in simulated body fluid, there is Ca-P layer deposition on the surface, illustrates that this blade plate and screw have good biological activity.Implant animal body in the time of interior back 1 month, around blade plate, have a large amount of cambiums to surround, and cambium is less relatively around the titanium alloy blade plate, fails to wrap up blade plate.Proof, this magnesium alloy blade plate have excellent biological activity.
Shown in Fig. 3-12, ZK60 (magnesium-zinc system) magnesium alloy is made into L shaped, T shape, trilobal, Y shape, abnormity, arc, S shape blade plate and nail to be soaked in simulated body fluid 3 days, there is Ca P layer deposition on the surface, illustrates that this blade plate has good biological activity.
AM60 (magnesium-aluminum system) magnesium alloy is processed into intramedullary pin, after polishing, ultrasonic cleaning 5 minutes in acetone, ethanol respectively, at the vacuum drying oven inner drying, adopt the apatite layer of heat spraying method then, further improve the osteoinductive energy of intramedullary pin at the thick 5 μ m of magnesium alloy blade plate surface spraying.
Embodiment 4
Adopt Mg94-Ca5-Zn1 (magnesium-calcium system) preparation lag screw, (bionical solution composition is: Na to adopt bionic method
2HPO412H
2O:20-60gg/l, Ca (NO
3)
2: 30-50g/l, all the other are water; Temperature: 25-90 ℃, the time: 2-48h) surface preparation goes out β-TCP coating outside, and its thickness is 100 μ m.Prepared lag screw soaked 1 day in simulated body fluid, and the surface has osteoid apatite to form, as shown in figure 13.Along with the prolongation of soak time, surperficial β-TCP coating is degraded gradually, and magnesium alloy substrate continues to interact with simulated body fluid, and the surface continues to have biological activity Ca-P layer to form.
Embodiment 5
Adopt ZAC8502 (magnesium-zinc system) magnesium alloy to prepare interference screw, behind the implantable bioartificial body damaged part, be organized within the two weeks and heal, and along with the prolongation of the time of implantation, interference screw is absorbed in vivo.
Embodiment 6
Adopt MB1 (magnesium-manganese system) magnesium alloy to prepare the pulling force nail, implantable bioartificial body damaged part is after 1 month, the pulling force nail is firm with the surrounding bone tissue bond, and around the pulling force nail, there is freshman bone tissue to form, analyze through section, in freshman bone tissue, have bone trabecula to exist, and do not have bone trabecula in the freshman bone tissue around the titanium alloy pulling force nail, prove that this magnesium alloy pulling force nail has excellent biological activity, can induce freshman bone tissue to form.
Embodiment 7
Adopt K1A (magnesium-zirconium alloying) magnesium alloy to prepare the fracture dislocation of spine fixation device, implantable bioartificial body damaged part is after 1 month, and is firm with the surrounding bone tissue bond, and has freshman bone tissue to form around, analyze through section, in freshman bone tissue, have bone trabecula to exist.
Embodiment 8
Adopt WE43 (magnesium-rare earth system) magnesium alloy to prepare spicule, (with the platinized platinum is anode, and spicule is a negative electrode, and electrolyte is the CaCl of 10-4mol/L to adopt electrochemical deposition technique
2And Na
2The mixed solution of HPO4, pH are 5.5-7.0, and temperature is 90-100 ℃, and electric current density is 0.25-1.75mA/cm
2, sedimentation time is 25-180min, dries in the air) and surface preparation hydroxyapatite coating layer outside, its thickness is 150 μ m.Implantable bioartificial body damaged part is after 1 month, and is firm with the surrounding bone tissue bond, and has freshman bone tissue to form around, analyzes through section, has bone trabecula to exist in freshman bone tissue.
Embodiment 9
Adopt LA141 (magnesium-lithium system) magnesium alloy to prepare biological activity hone lamella, nail, adopt vacuum plasma spray coating technology (Ar, H
2Be plasma gas, vacuum chamber pressure is 150mbar, and the powder feeding rate is 20g/min, electric current 650A, voltage 60V), utilize the hydroxyapatite powder of particle size range for 10-100 μ m, surface preparation goes out hydroxyapatite outside, gained hydroxyapatite coating layer thickness is 130 μ m.Implantable bioartificial body damaged part is after 1 month, and is firm with the surrounding bone tissue bond, and has freshman bone tissue to form around, analyzes through section, has bone trabecula to exist in freshman bone tissue.
Claims (9)
1, a kind of biological and adsorbable bone internal fixation implantation instrument is characterized in that: this bone internal fixation implantation instrument is an internal fixation device spare, and internal fixation device spare is made by the magnesium metal and the alloy thereof of biologically active and absorbability.
2, biological and adsorbable bone internal fixation implantation instrument as claimed in claim 1 is characterized in that: the magnesium alloy of biologically active and absorbability is: the alloy system that magnalium series alloy, magnesium manganese series alloy, magnesium zinc series alloy, magnesium zirconium series alloy, magnesium rare earth metal alloy, magnesium lithium series alloy, magnesium calcium series alloy or magnesium silver series alloy etc. are different a kind of or the ternary system or the polynary system magnesium alloy that are formed by these system combinations.
3, according to claim 1 or 2 described biological and adsorbable bone internal fixation implantation instruments, it is characterized in that: in the magnesium alloy, the weight content 0～10% of aluminum; The weight content 0～5% of Zn, Mn, Si and/or RE; The weight content 0～1% of Zr; The weight content 0～15% of Li; The weight content 0～10% of Ca; The weight content 0～12% of Ag.
4, biological and adsorbable bone internal fixation implantation instrument as claimed in claim 1, it is characterized in that: biological activity magnesium alloy bone immobilising device surface prepares one deck overcoat by ion implantation, thermal spraying, ion plating, sputter, chemical vapour deposition (CVD), laser melting coating, plasma technique, electrochemical method or biochemical method, the degradation speed of control magnesium alloy and the dissolution rate of magnesium ion, thereby control magnesium alloy device biological activity and infiltration rate in vivo; Overcoat thickness is 0.1-200 μ m, and overcoat is hydroxyapatite coating layer, bata-tricalcium phosphate coating, magnesium oxide coating, fluorine-containing overcoat or phosphorous overcoat.
5, biological and adsorbable bone internal fixation implantation instrument as claimed in claim 1 is characterized in that: internal fixation device spare comprises blade plate and supporting screw, intramedullary pin, fracture dislocation of spine fixation device, spicule or plays the screw of fixation separately.
6, biological and adsorbable bone internal fixation implantation instrument as claimed in claim 5 is characterized in that: described blade plate comprises the pressurization hone lamella that is used for long bone shaft fracture; Perhaps, the reconstruction hone lamella that is used for pelvis, distal humerus, clavicle or outer fracture of ankle; Perhaps, the femur ankle supports that hone lamella, calcaneus and toe (finger) bone blade plate, repair of cranial defects hone lamella, the facial blade plate of jaw or defect repair hone lamella privileged sites hone lamella are supported in the outside in hone lamella, the tibial plateau outside and the far-end; Perhaps, the special-shaped blade plate of herringbone, arc, L shaped, T shape, Y shape, trilobal, I-shaped hone lamella or other special requirements.
7, biological and adsorbable bone internal fixation implantation instrument as claimed in claim 5 is characterized in that: but described intramedullary pin comprises single nail, many nails, strong intramedullary pin or tropism intramedullary pins.
8, biological and adsorbable bone internal fixation implantation instrument as claimed in claim 5 is characterized in that: described fracture dislocation of spine fixation device comprises hone lamella, hold-down bars, screw, hook or steel wire.
9, biological and adsorbable bone internal fixation implantation instrument as claimed in claim 5 is characterized in that: described screw comprises and matching used screw of hone lamella and independent lag screw or the interference screw that plays fixation; Screw is divided into self thread-cutting screw or non-self thread-cutting screw, and os integumentale screw or cancellous bone screw, and os integumentale screw is the full thread nail, and cancellous bone screw divides screw rod and screw thread two parts.
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