CN103142300B - A kind of Novel multifunctional bone plate and application thereof - Google Patents

A kind of Novel multifunctional bone plate and application thereof Download PDF

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CN103142300B
CN103142300B CN201310046605.XA CN201310046605A CN103142300B CN 103142300 B CN103142300 B CN 103142300B CN 201310046605 A CN201310046605 A CN 201310046605A CN 103142300 B CN103142300 B CN 103142300B
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blade plate
hole
degradable
plate
magnesium
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CN103142300A (en
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任伊宾
邵传伟
肖克沈
杨柯
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Institute of Metal Research of CAS
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Abstract

The object of this invention is to provide a kind of Novel multifunctional bone plate, this blade plate is thin strip-plate, its plate face have 2 nail at least, fixing for blade plate, it is characterized in that: there is the through hole run through wherein described blade plate inside, through hole inside is filled and can be promoted the various medicine of bone healing or reparation and/or similar implant, gives blade plate multi-functional characteristic.Be mainly used in human or animal's fractured type internal fixtion or Plastic renovation use.The blade plate of contrast clinical practice, blade plate of the present invention runs through through hole by inner, reduces the cross-sectional area of blade plate, reduces the modulus of blade plate, effectively reduce stress-shielding effect, help lend some impetus to the healing of fracture.Meanwhile, fill functional material in blade plate through hole inside and make it have multi-functional characteristic.

Description

A kind of Novel multifunctional bone plate and application thereof
Technical field
The invention belongs to the fixed apparatus field of orthopaedics in medical apparatus and instruments, particularly a kind of Novel multifunctional bone plate and range of application thereof.
Background technology
At present widely used various orthopedic fixer tool mainly adopts the inert metal materials such as rustless steel, cobalt-base alloys and titanium alloy to make clinically, and the subject matter existed clinically comprises not the mating of material and tissue mechanical property, non-degradable etc.The elastic modelling quantity of normal person's osseous tissue is about 20GPa, and the elastic modelling quantity of conventional metals bone fixture is all higher than 100Gpa, and in the elastic modelling quantity caused thus and intensity, notable difference can produce stress shielding effect, affects symphysis, even again damages.
316L rustless steel blade plate compares titanium alloy blade plate clinically at present, maximum inferior position is exactly that its higher elastic modelling quantity brings obvious stress-shielding effect, and the intensity namely caused skeleton due to the mechanics shunting of immobilization material reduces and the biological impact such as healing delay.There are some researches show, the stress shielding under blade plate loading conditions is relevant with the cross-sectional area of blade plate, and cross-sectional area is less, and stress-shielding effect is less.The new medical high nitrogen and nickel-less austenitic stainless steel developed in recent years has excellent mechanical property relative to conventional medical 316L rustless steel, while the excellent plasticity and toughness of maintenance, intensity improves nearly more than one times, therefore medical embedded material is under intensity meets prerequisite, completely can optimized dimensions and structural design, realize lightweight.So suitably reduce hone lamella cross-sectional area, completely can ensure, under the condition that safety is on active service, suitably to reduce the stress-shielding effect of rustless steel blade plate, improve the healing effect of fracture.
Summary of the invention
The object of this invention is to provide a kind of Novel multifunctional bone plate, be mainly used in human or animal's fractured type internal fixtion or Plastic renovation use.
The present invention specifically provides a kind of Novel multifunctional bone plate, blade plate is thin strip-plate, its plate face have 2 nail at least, fixing for blade plate, it is characterized in that: there is the through hole run through wherein described blade plate inside, through hole inside is filled and can be promoted the various medicine of bone healing or reparation and/or similar implant, gives blade plate multi-functional characteristic.
This blade plate base body material can be the medical metal materials such as medical stainless steel, Medical Cobalt-Based Alloys, medical titanium alloy, also can be other Srgery grafting material such as medical macromolecular materials and medical composite material.Blade plate can be fracture bone plate, and hone lamella etc. is fixed by pressurized bone plate and dynamic pressurization hone lamella or Wicresoft.
Novel multifunctional bone plate provided by the invention, it is characterized in that: according to the thickness of blade plate, between 0.5mm-4mm, (namely thin plate adopts minor diameter through hole to the diameter of described through hole, slab adopts the combination of diameter through hole or large and small diameter through hole), the minimum dimension of through hole outer rim and surrounded surface is not less than 25% of hone lamella thickness or width.Blade plate inner via hole generally adopts circular hole, electric spark perforate can be adopted to obtain, through hole also can be obtained by depth drill boring, through-hole inner surface must use after pickling and polishing, longer size through hole can obtain through mechanical pull in electric spark perforate or boring basis, and through hole also can adopt specific process to be processed into square hole, elliptical aperture or irregularly-shaped hole etc.
In order to ensure the intensity that blade plate is enough, the minimum dimension of blade plate through hole outer rim and surrounded surface is more than or equal to 25% of hone lamella thickness or width, namely the through hole in blade plate mainly concentrates on the centre of blade plate, such as 1mm is thick, the clear size of opening that the wide miniplate of 5mm can be processed is not more than 0.5mm, can have 3 through holes side by side, at least blade plate top and bottom at least retain 0.25mm thickness, and the left and right sides at least retains 1.25mm width.
Novel multifunctional bone plate provided by the invention, it is characterized in that: in order to reduce the cross-sectional area of blade plate, effective reduction stress-shielding effect, there is the through hole run through wherein Novel multifunctional bone plate inside of the present invention, and described number of openings is more than or equal to 1, and the arrangement mode of through hole can be evenly distributed, also can according to certain way arrangement or random alignment, can be single and through hole that is hone lamella thickness matching, also can be the orderly or lack of alignment of many row's apertures, pitch of holes be more than or equal to 0.5mm.
For apertures biological bone substitution material, the internal connectivity in aperture, porosity and hole is the determiner of Bone Ingrowth mode and quantity.Porosity size should meet the space needed for osteon and bone cell growth, when implantation body's inside connection pore and aperture are 5-40 μm, allows fibrous tissue to grow into; Aperture allows the osteoid tissue of non-mineralising to grow into when being 40-100 μm; When aperture size is greater than 150 μm, ideal place can be provided for growing into of osseous tissue; When hole dimension is greater than 200 μm, bone conduction reaches basic demand; 200-400 μm is conducive to new bone growth most.Blade plate interior bone of the present invention does not wish that osseous tissue is grown into, minimum-value aperture of the present invention appears on the thick miniature hone lamella of 1mm, be not less than 0.5mm, the selection in aperture selects larger aperture as far as possible so that processing reduces new bone and inwardly grows simultaneously in a word, meanwhile, being usually filled with functional material in blade plate through hole of the present invention also can prevent new bone from inwardly growing.
In order to realize the multi-functional characteristic of blade plate, blade plate inner via hole inside is filled and can be promoted the various medicine of bone healing or reparation or similar degraded or nondegradable implant, described promote the various medicines of bone healing or reparation be anti-inflammatory drugs, analgesic drug, blood-activating stasis-removing kind medicine, other functional drug one or more.Wherein, other functional drug can be trace element or Osteoinductive Factor.
Such as fill the infection inflammation etc. in antibiotics reduction bone healing process, as gentamycin, tobramycin, vancomycin etc., fill the pain in analgesic drug reduction of patient union of fracture early stage, fill blood-activating stasis-removing kind medicine accelerated bone folding part and divide the rapid metabolization such as soft tissue injury, fill the trace element such as calcium phosphorus, Osteoinductive Factor etc. accelerate the healing etc. of fracture, also can be the functions that the mixing of these medicines reaches compound Promotive union.Filled drug, except clinical Western medicine, also with clinical Chinese medicine, can comprise nourshing blood and promoting blood circulation class Chinese medicine as Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, Radix Paeoniae Rubra etc.; Blood circulation promoting and blood stasis dispelling class Chinese medicine is as Rhizoma Chuanxiong, Flos Carthami, Pollen Typhae etc.; Stasis-dispelling and pain-killing class Chinese medicines is as Olibanum, Myrrha, Rhizoma Corydalis etc.; Removing blood stasis eliminating stagnation class Chinese medicine is as three rib, Rhizoma Curcumae, Semen Persicae etc.
Except filled drug, also can fill similar degraded or nondegradable implant, described implant be degradable embedded material, nondegradable embedded material, various bone cement material one or more.
Wherein, described degradable embedded material is one or more of the degradation materials such as degradable high polymer material, degradable Inorganic Non-metallic Materials, the pure Mg-based hydrogen storage of degradable, degradable composite material, degradable bone cement.The ion discharged by degradable product or beneficiating ingredient, promote healing or the reparation of skeleton.
In order to ensure the safety and health of patient, the degradable high polymer material of filling is natural degradable macromolecular material or synthesized degradable macromolecular material as far as possible; Wherein, natural degradable macromolecular material is collagen protein, gelatin and/or chitin; Synthesized degradable macromolecular material is that polylactide, PGA, polybutylcyanoacrylate, polycaprolactone, condensing model, poe and/or poly-phosphorus are fine, or copolymer between above-mentioned polymer and other degradable high polymer material;
Described degradable Inorganic Non-metallic Materials is the bioactive ceramics such as non-stoichiometric apatites, tricalcium phosphate;
The pure Mg-based hydrogen storage of described degradable is a kind of of magnesium strontium alloy, magnesium-manganese alloy, magnesium-zinc alloy, Mg-Zr alloys, magnesium-rare earth alloy, magnesium lithium alloy, magnesium calcium alloy and magnalium or by the ternary system of these system combinations or polynary system magnesium alloy.
Novel multifunctional bone plate provided by the invention, is characterized in that: described blade plate is straight type thin plate, trilobal cross thin plate, Y type thin plate, drum thin plate, L-type thin plate, T-shaped thin plate or other special-shaped thin plate customized according to needs of patients; The face of blade plate is plane, concave surface, cambered surface, noncontinuity Limited contact plate face or have the shaped face being beneficial to Rehabilitation.
The advantage of Novel connecting hone lamella provided by the present invention
1, the blade plate of clinical practice is contrasted, blade plate of the present invention runs through through hole by the inner varying number of blade plate and size, reduces the cross-sectional area of blade plate, reduces the modulus of blade plate, effective reduction stress-shielding effect, helps lend some impetus to the healing of fracture.
2, blade plate of the present invention has multi-functional characteristic by its inner functional material of filling of blade plate interior bone, first be fill the healing that variety classes medicine promotes fracture, next fills slow degraded of degradation material one side ensures the slow reduction of blade plate modulus, to make after fracture stressed transfers to skeleton from blade plate gradually, reduce and avoid stress shielding, the part ion on the other hand in catabolite and beneficiating ingredient can promote the healing of fracturing.
Range of application:
Novel multifunctional bone plate provided by the invention, be mainly used in human or animal's fractured type internal fixtion or Plastic renovation use, can be used for the internal fixtion of the long bone fractures such as fracture of upper limb, fracture of the lower limb, spinal fracture, jaw fracture, os pelvicum fracture, clavicular fracture, fracture of rib, short bone fracture, flat bone fracture and irregular bone fracture.
Accompanying drawing explanation
Fig. 1 miniplate structural representation;
Fig. 2 internal rigid fixation structural representation;
The T-shaped blade plate structural representation of Fig. 3;
Fig. 4 L-type blade plate structural representation;
Fig. 5 cambered surface straight type blade plate structural representation.
Detailed description of the invention
Embodiment 1:
As shown in Figure 1, multifunctional access hone lamella of the present invention is that 1mm is thick, and 5mm is wide, the miniplate that 25mm is long, plate face has 4 nail 1, there are 3 through holes 2 run through wherein the inside of blade plate, and through-hole diameter is 0.5mm, hole wall spacing is about 0.5mm, the existence of blade plate interior bone makes blade plate sectional area reduce 15.7%, effectively can reduce stress-shielding effect, is filled with implant 3 in through hole simultaneously, described implant is the mixture of gentamycin and starch, gives the characteristic of blade plate anti-inflammation.
Embodiment 2:
As shown in Figure 2, multifunctional access hone lamella of the present invention is that 2mm is thick, 6mm is wide, the internal rigid fixation that 30mm is long, plate face there are 4 nail 1, there are 2 through holes 2 run through wherein blade plate inside, through-hole diameter is 1mm, hole wall spacing is about 1.5mm, the existence of blade plate interior bone makes blade plate sectional area reduce 12.1%, effectively can reduce stress-shielding effect, be filled with implant 3 in through hole simultaneously, described implant is the mixture of collagen protein and hydroxyapatite powder, by the slow degraded of collagen protein and hydroxyapatite, for fracture repair provides nutrient, give blade plate multi-functional characteristic.
Embodiment 3:
As shown in Figure 3, multifunctional access hone lamella of the present invention is that 5mm is thick, and 16mm is wide, the T-shaped blade plate that 200mm is long, plate face has 10 nail 1 at least, there are 10 through holes 2 run through wherein blade plate inside, is arranged in 2 rows, through-hole diameter is 1mm, often arrange inner hole wall spacing and be about 1mm, the hole wall spacing between 2 exhausting holes is 0.5mm, and 2 through holes run through wherein are arranged at blade plate top, through-hole diameter is 3mm, spacing 2mm.The existence of blade plate interior bone makes blade plate sectional area reduce 9.8%-17.6%, effectively can reduce stress-shielding effect, be filled with implant 3 in through hole simultaneously, described implant is 1mm magnesium calcium alloy silk, by the slow degraded of magnesium calcium alloy silk, for fracture repair provides magnesium ion and calcium ion, promote union of fracture, give blade plate multi-functional characteristic.
Embodiment 4:
As shown in Figure 4, multifunctional access hone lamella of the present invention is that 5mm is thick, and 16mm is wide, the L-type blade plate that 150mm is long, plate face has 10 nail 1 at least, and there are 2 through holes 2 run through wherein blade plate inside, and through-hole diameter is 3mm, and hole wall spacing is about 3mm.The existence of blade plate interior bone makes blade plate sectional area reduce 8.83%, effectively can reduce stress-shielding effect, be filled with implant 3 in through hole simultaneously, described implant is calcium phosphate bone cement material, slowly degraded by calcium phosphate bone cement, for fracture repair provides calcium and phosphorus ions, promote union of fracture, give blade plate multi-functional characteristic.
Embodiment 5:
As shown in Figure 5, multifunctional access hone lamella of the present invention is that 5mm is thick, 16mm is wide, the straight type blade plate of cambered surface that 200mm is long, plate face has 10 nail 1 at least, and there are 9 through holes 2 run through wherein blade plate inside, through hole is respectively aperture that 8 diameters are 1.5mm and a diameter is the macropore of 3mm, macropore is placed in the middle, and the uniform both sides of aperture, hole wall spacing is about 1mm.The existence of blade plate interior bone makes blade plate sectional area reduce 26.5%, effectively can reduce stress-shielding effect, be filled with implant 3 in 3mm through hole simultaneously, described implant is the mixture of vancomycin antibiotic and degradable poly lactic acid, magnesium zinc strontium calcium alloy silk is filled in 1.5mm through hole 2, by the degraded of degradable poly lactic acid, antibiotic discharges, magnesium zinc strontium calcium alloy is slowly degraded simultaneously, simultaneously for fracture repair provides the metal ion such as antiinflammatory and magnesium zinc strontium calcium, promote union of fracture, give blade plate multi-functional characteristic.
Embodiment 6
Difference from Example 2 is:
What fill in blade plate through hole 2 is the mixture of Radix Salviae Miltiorrhizae, degradable gelatin and hydroxyapatite powder, provides aminoacid and apatite to provide calcium and phosphorus ions, promote union of fracture, give blade plate multi-functional characteristic by the blood circulation promoting and blood stasis dispelling of Radix Salviae Miltiorrhizae and gelatin.
Embodiment 7
Difference from Example 5 is:
Antibiotic-loaded bone cement material is filled in 3mm through hole 2, filling degradable magnesium-zinc alloy silk in 1.5mm through hole 2, provide antiinflammation by antibiotic-loaded bone cement degraded, magnesium-zinc alloy is slowly degraded to the metal ions such as fracture repair magnesium zinc, promote union of fracture, give blade plate multi-functional characteristic.
Embodiment 8
Difference from Example 4 is:
Fill the mixture of tricalcium phosphate and polylactic acid in through hole 2, be degraded to the metal ions such as fracture repair calcium phosphorus by tricalcium phosphate, promote union of fracture, give blade plate multi-functional characteristic.
Above-described embodiment, only for technical conceive of the present invention and feature are described, its object is to person skilled in the art can be understood content of the present invention and implement according to this, can not limit the scope of the invention with this.All equivalences done according to spirit of the present invention change or modify, and all should be encompassed within protection scope of the present invention.

Claims (7)

1. a multifunctional access hone lamella, described blade plate is thin strip-plate, its plate face has 2 nail at least, it is characterized in that: blade plate inside has runs through through hole wherein along blade plate length direction, and through hole is connected with nail; Various medicine and/or other implant that can promote bone healing or reparation are filled in through hole inside; The diameter of described through hole is between 0.5mm-4mm, and the distance on through hole outer rim and blade plate surface is not less than 25% of blade plate thickness or width, and through hole can be circular hole, square hole, elliptical aperture or irregularly-shaped hole; Other implant described be degradable embedded material, nondegradable embedded material, various bone cement material one or more.
2. according to multifunctional access hone lamella described in claim 1, it is characterized in that: described number of openings is more than or equal to 1, adopt electric spark perforate or boring, and cooperative mechanical drawing obtains; The arrangement mode of through hole can be evenly distributed, also can according to certain way arrangement or random alignment, and pitch of holes is more than or equal to 0.5mm.
3., according to multifunctional access hone lamella described in claim 1, it is characterized in that: described promote the various medicines of bone healing or reparation be anti-inflammatory drugs, analgesic drug, blood-activating stasis-removing kind medicine, other functional drug one or more.
4. according to multifunctional access hone lamella described in claim 3, it is characterized in that: other functional drug described is trace element or Osteoinductive Factor.
5., according to multifunctional access hone lamella described in claim 1, it is characterized in that: described degradable embedded material be degradable high polymer material, degradable Inorganic Non-metallic Materials, the pure Mg-based hydrogen storage of degradable, degradable composite material, degradable bone cement one or more.
6. according to multifunctional access hone lamella described in claim 5, it is characterized in that: described degradable high polymer material is natural degradable macromolecular material or synthesized degradable macromolecular material; Wherein, natural degradable macromolecular material is collagen protein, gelatin and/or chitin; Synthesized degradable macromolecular material is that polylactide, PGA, polybutylcyanoacrylate, polycaprolactone, condensing model, poe and/or poly-phosphorus are fine, or copolymer between above-mentioned polymer and other degradable high polymer material;
Described degradable Inorganic Non-metallic Materials is non-stoichiometric apatites, tricalcium phosphate;
The pure Mg-based hydrogen storage of described degradable is a kind of of magnesium strontium alloy, magnesium-manganese alloy, magnesium-zinc alloy, Mg-Zr alloys, magnesium-rare earth alloy, magnesium lithium alloy, magnesium calcium alloy and magnalium or by the ternary system of these system combinations or polynary system magnesium alloy.
7. according to the described multifunctional access hone lamella of one of claim 1 ~ 6, it is characterized in that: described blade plate is straight type thin plate, trilobal cross thin plate, Y type thin plate, drum thin plate, L-type thin plate, T-shaped thin plate or other special-shaped thin plate customized according to needs of patients; The face of blade plate is plane, concave surface, cambered surface, noncontinuity Limited contact plate face or have the shaped face being beneficial to Rehabilitation; Blade plate base body material is medical metal material, medical macromolecular materials or medical composite material, and wherein medical metal material is medical stainless steel, Medical Cobalt-Based Alloys or medical titanium alloy.
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CN104083200B (en) * 2014-06-18 2017-08-25 姜玉兰 A kind of Orthopedic fixation device
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CN104042319A (en) * 2014-06-27 2014-09-17 江苏艾迪尔医疗科技股份有限公司 T-shaped maxillofacial bone fracture plate
CN104095674B (en) * 2014-07-15 2016-04-13 东南大学 The absorbable-bone plate of self adaptation attaching type band shirt rim
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CN104825219A (en) * 2015-05-03 2015-08-12 刘乐 Bone plate for minimally invasive surgery
CN106267380A (en) * 2015-06-05 2017-01-04 上海微创医疗器械(集团)有限公司 A kind of blade plate and manufacture method thereof
CN105078558A (en) * 2015-07-13 2015-11-25 济南大学 Novel tibia straight bone plate
CN105167834A (en) * 2015-10-30 2015-12-23 重庆医科大学附属永川医院 Inner fixing steel plate capable of promoting fracture healing for orthopaedics department
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