CN107841646A - A kind of porous tantalum - Google Patents

A kind of porous tantalum Download PDF

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Publication number
CN107841646A
CN107841646A CN201610834435.5A CN201610834435A CN107841646A CN 107841646 A CN107841646 A CN 107841646A CN 201610834435 A CN201610834435 A CN 201610834435A CN 107841646 A CN107841646 A CN 107841646A
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China
Prior art keywords
porous tantalum
vestibule
tantalum
bone tissue
porous
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CN201610834435.5A
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Chinese (zh)
Inventor
叶雷
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Chongqing Runze Pharmaceutical Co Ltd
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Chongqing Runze Pharmaceutical Co Ltd
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Priority to CN201610834435.5A priority Critical patent/CN107841646A/en
Publication of CN107841646A publication Critical patent/CN107841646A/en
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    • C—CHEMISTRY; METALLURGY
    • C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22C—ALLOYS
    • C22C27/00—Alloys based on rhenium or a refractory metal not mentioned in groups C22C14/00 or C22C16/00
    • C22C27/02—Alloys based on vanadium, niobium, or tantalum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02—Inorganic materials
    • A61L27/04—Metals or alloys
    • A61L27/047—Other specific metals or alloys not covered by A61L27/042 - A61L27/045 or A61L27/06
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56—Porous materials, e.g. foams or sponges
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B22—CASTING; POWDER METALLURGY
    • B22F—WORKING METALLIC POWDER; MANUFACTURE OF ARTICLES FROM METALLIC POWDER; MAKING METALLIC POWDER; APPARATUS OR DEVICES SPECIALLY ADAPTED FOR METALLIC POWDER
    • B22F3/00—Manufacture of workpieces or articles from metallic powder characterised by the manner of compacting or sintering; Apparatus specially adapted therefor ; Presses and furnaces
    • B22F3/10—Sintering only
    • B22F3/11—Making porous workpieces or articles
    • B22F3/1121—Making porous workpieces or articles by using decomposable, meltable or sublimatable fillers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Materials Engineering (AREA)
  • Metallurgy (AREA)
  • Organic Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Manufacturing & Machinery (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)

Abstract

The invention discloses a kind of medical porous tantalum, the material body of the porous tantalum is formed by vestibule and around the cavity wall of vestibule, vestibule is insertion, the porous tantalum absorbs energy and is not less than 3.58 × 10 when strain reaches 50% when strain reaches 50% still in plateau stress stage, the unit volume of porous tantalum‑4J/mm3, this kind of medical porous tantalum have good energy absorption capability, can meet the needs of body bone tissue is grown into, and for bearing the spongiosa Bone Defect Repari implant of side crops industry, osteanagenesis effect is good after implantation.

Description

A kind of porous tantalum
Technical field
The present invention relates to porous material, more particularly to a kind of porous tantalum for medical embedded material.
Background technology
Tantalum metal is due to relative inertness and to biological properties such as body tissue nonhazardous, becoming manufacture Srgery grafting Ideal material, and entity tantalum modulus of elasticity is excessive relative to bone tissue, and be unfavorable for it is effectively combined with bone tissue, therefore, People start to develop porous tantalum.Researcher thinks that porous tantalum possesses the advantages of both porous metal material and metal tantalum, not only There can be good mechanical property but also suitable modulus of elasticity can be possessed, like this, be easy to induction and produce bone tissue； Because porous tantalum can have the characteristics such as higher porosity and skin-friction coefficient so that porous tantalum is expected to should as Orthopedic Clinical There is a kind of new material of good development prospect with field.
Although people have carried out many researchs to porous tantalum, as Zhang Y et al. have carried out the research of porous tantalum friction behavior （Interfacial frictional behavior；cancellous bone, cortical bone, and a novel porous tantalum biomaterial. J Musculoskeletal Res. 1999）；Jia Xiaojun is to porous tantalum elasticity Modulus is studied（Porous tantalum metal bar implantation joint core decompression treatment femoral head osteonecrosis [J] medical cares forum, 2009,16 (25): 145-146.）；Chen Changjun etc. has carried out the method for fast mfg system using laser multilayer cladding microsecond delay The research of standby porous tantalum（The preparation method and device of CN102409195A porous tantalums)；But this series of studies achievement is made Medical embedded material, practical application effect is bad all the time.At present, it is porous either seen by the still in the market of document report Tantalum medical embedded material, after being implanted into human body, body bone tissue can not be normally grown into implantation material, namely this implantation material is not Bone tissue regeneration can be realized, cannot also turn into bone renovating material truly.
The content of the invention：
Be advantageous to the good medical embedded regrown material of bone growth, Bone Defect Repari effect it is an object of the invention to provide a kind of --- Porous tantalum material.
It has been recognised by the inventors that being implanted into regrown material as bone, it does not need only to have certain impact resistance to avoid tying Structure collapses, it is often more important that energy absorption possessed by it will be more beneficial for the growing into meet that bone renovating material should of bone tissue The real regeneration function having.
The object of the invention is achieved through the following technical solutions：
A kind of porous tantalum, the material body of the porous tantalum are mainly formed by vestibule and around the cavity wall of vestibule, and vestibule is insertion, The porous tantalum is not more than 95% when strain reaches 50% still in plateau stress stage, the porosity of the porous tantalum, unit Volume-absorption energy is not less than 3.5 × 10 when strain reaches 50%-4 J/mm3.Such porous tantalum is as bone implantation piece, especially Be advantageous to bone tissue to start to grow.After the implantation, because it has more appropriate energy absorption capability, there is appropriate buffering effect Fruit, remain to be in the plateau stress stage when strain reaches 50%, the good growth ring that bone tissue can be supplied to just to grow into after implantation Border, be advantageous to bone tissue regeneration, this porous tantalum is applied to the small spongiosa Bone Defect Repari implant of stress, such as cheekbone, skull, phalanges Deng the cancellous bone of bone.
Furtherly, described porous tantalum, its porosity are not more than 90%, and aperture is 400-500 μm, and unit volume absorbs Energy is not less than 0.70 × 10 when strain reaches 50%-3 J/mm3.The unit volume absorption energy of such porous tantalum is higher, Buffering effect is preferable, this porous tantalum spongiosa Bone Defect Repari implant small as stress, is more beneficial for bone tissue and grows into.
Furtherly, described porous tantalum, its porosity are not more than 85%, and aperture is 400-500 μm, and unit volume absorbs Energy is not less than 0.10 × 10 when strain reaches 50%-2 J/mm3.Such porous tantalum, its unit volume absorb energy and enter one Step improves, and the spongiosa Bone Defect Repari implant small for stress, bone tissue grows into better.
Beneficial effects of the present invention：
Porous tantalum provided by the invention, due to having done preferable selection to its energy absorption capability, it not only has appropriate delay Rush effect, impact resistance, it is often more important that its first growth to bone tissue, the speed of growth for growing into effect and bone tissue have Help.It can meet what the small spongiosa Bone Defect Repari implant bone tissue of the needs of body bone tissue is grown into, particularly stress was grown into Demand, the osteanagenesis after implantation work well, and are a kind of ideal bone renovating materials.
Porous tantalum provided by the invention is implanted into material, is mutually communicated between its vestibule, and vestibule is also insertion with external environment, The porous tantalum of this structure is particularly conducive to the transmission of tissue fluid, and bone tissue is grown into, as implant and body bone tissue knot Close firmly, good biocompatibility, function admirable, be a kind of bone-regeneration material of real meaning.
It is also known that body bone tissue is often in motion, so also can after being implanted into human body as bone implant material It is often subject to the effect of power.And porous tantalum implantation material provided by the invention, there is suitable energy absorption capability, not only have Good buffering effect, stronger impact resistance, external force can be avoided to cause implant and bone tissue damages and structural collapse, dimension Hold normal physiological function；And these active forces can be transferred to body bone tissue by it, bone cell growth is stimulated so that bone tissue It can grow into and implant, and upgrowth situation is good, realizes osteanagenesis；Patient generally produces foreign body sensation in vivo for implant It has been mitigated that, improve the postoperative life quality of patient.
Embodiment
The embodiment of the present invention will be explained below, embodiment is given premised on technical solution of the present invention Detailed embodiment and specific operating process are gone out, but protection scope of the present invention is not limited only to embodiment disclosed below.
Embodiments of the invention are given in detail below.
Embodiment 1：
The porous tantalum of the present embodiment, it is mutually communicated between its vestibule and vestibule, vestibule is also insertion with the external world, the porous tantalum The aperture of vestibule is 400 μm -500 μm, and porosity 95%, preparation method is as follows：
It is 5 ± 1 μm of tantalum powder to take particle diameter, particle diameter be 500-600 μm of polymethyl methacrylate as pore creating material, according to volume Compare tantalum powder：Polymethyl methacrylate powder is 1：19 mixing, repeatedly stirring make it that mixed powder uniformly are put into sintered carbide die Tool, apply 500MPa pressure compactions, pressurize 20s, the sample of compacting is taken out, is put into vacuum drying oven, start cryopumping：With FF-160/620 types molecular pump+mechanical pump vacuum systems vacuumize and reach 10-4Pa, risen to 1 DEG C/min speed from room temperature 300 DEG C, it is incubated 90min；Then 400 DEG C are risen to same firing rate, is incubated 60min；Again 500 are risen to same firing rate DEG C, it is incubated 60min；Then same firing rate rises to 600 DEG C, is incubated 40min；Then high temperature sintering is carried out：With 8 DEG C/min Speed rise to 1200 DEG C from room temperature, be incubated 30min；Then 1600 DEG C are risen to 10 DEG C/min speed, is incubated 40min；With 40 DEG C/min speed rises to 2300 DEG C, is incubated 140min；1400 DEG C are cooled to 10 DEG C/min speed again, insulation 30min；1150 DEG C are cooled to 10 DEG C/min speed, is incubated 60min；750 DEG C are cooled to 10 DEG C/min speed；So Furnace cooling afterwards.Made annealing treatment：Sample is put into vacuum annealing furnace, vacuum is reached 10-4Pa, with 120 DEG C/min Speed rise to 1250 DEG C from room temperature, be incubated 280min；1000 DEG C are cooled to 5 DEG C/min speed again, is incubated 200min； 700 DEG C are cooled to 10 DEG C/min speed, is incubated 160min；Room temperature is cooled to 16 DEG C/min speed, finally carried out normal Porous tantalum is made in rule post processing.
The porosity of the present invention refers to that material internal pore volume accounts for the percentage of its cumulative volume.Porosity is according to direct body Product weight method measures, and first measures the quality of sample, then measures the volume of sample, according to the volume of sample and sample material dense body Density draws the quality of the dense body suitable with the volume of sample, and the difference of the quality and sample mass is again divided by the volume with sample The quality of suitable dense body, then it is multiplied by 100% porosity for being sample.Porosity is measured as 95%.
The aperture of above-mentioned porous tantalum finished product is measured by GB/T5249-1985, it is 400 μm of -500 μ to measure aperture m。
Test percent opening according to GB/T5163-2006, according to the standard, after sample complete wetting the volume of contained oil divided by The volume of sample multiplied by with 100% be material percent opening, calculated after test further according to porosity, draw percent opening with The ratio of porosity is 98.6%.Illustrate inside vestibule and be to penetrate with external world.
Experiment is compressed with the testing machines of Instron 8801 according to GB/T 31930-2015, sample takes Φ 4mm × 6mm, 26 DEG C of test temperature, it is 3.585 × 10 to measure unit volume when strain reaches 50% to absorb energy value-4J/mm3, it is of the present invention Unit volume absorb energy and refer in porous material compressive stress strain curve from zero to 50% at strain or plateau stress knot The energy value obtained by domain integral at beam.
With above-mentioned similar preparation method and method of testing, will cancel in the wherein 1600-2300 DEG C of stage in preparation method, It is constant to prepare the ratio of porosity, aperture, percent opening and porosity, unit volume absorption energy value is when strain reaches 50% 1.643×10-4J/mm3Porous tantalum.
Above two porous tantalum is made to the particle of Φ 4 × 6mm sizes, packed after gamma-radiation sterilizes, it is stand-by.
The common experimental dog 4 of stone age maturation is chosen, male and female are regardless of body weight 14-16Kg, with 3% yellow Jackets in abdominal cavity Injecting anesthetic animal, after general anesthesia, hair at cheekbone is rejected, cuts cheekbone outer skin, hypodermis, muscle, periosteum is peeled off, uses tooth Section's dental drill drills on cheekbone, respectively by the porous tantalum particle of above two（It is a kind of two）Fill in, a dog plug one, Ran Houfen Layer suture.Art finishes intramuscular injection penicillin Incision infection prevention.12 weeks after operation, each execution 2 in 24 weeks（Each two is implanted into two kinds of porous tantalums Each one）, the cheekbone for being implanted into porous tantalum is removed, removes the soft tissue on surface as far as possible.Implantation material is taken out into observation, unit volume It is 3.585 × 10 to absorb energy-4J/mm3Porous tantalum 12 weeks, 24 weeks it is not cracked, damaged the defects of, unit volume is inhaled It is 1.643 × 10 to receive energy-4J/mm3Porous tantalum there are localized crackses within 12 weeks, 24 weeks, test material is fixed, embed, cut Piece, piece is thick 4 μm, area of new bone situation inside Masson trichrome stainings observation porous material.
Observation indicate that it is 3.585 × 10 that unit volume, which absorbs energy,-4J/mm3Porous tantalum 12 weeks after operation bone tissue 5% is grown into, 24 weeks bone tissues grow into 11%, and it is 1.643 × 10 that unit volume, which absorbs energy,-4J/mm3Porous tantalum 12 weeks after operation, It there are no bone tissue within 24 weeks to grow into, it is 3.585 × 10 to illustrate unit volume-absorption energy-4J/mm3Porous tantalum implantation after can be Cheekbone bone tissue, which is just grown into, creates good growing environment, and it is 1.643 × 10 that unit volume, which absorbs energy,-4J/mm3Porous tantalum Unit volume absorption energy is small, local failure occurs, cheekbone has no that bone tissue is grown into after implantation.
Embodiment 2
It is insertion between the vestibule and vestibule of the porous tantalum of the present embodiment, the vestibule of porous tantalum is more with extraneous and insertion The aperture of the vestibule of hole tantalum is 400-500 μm, porosity 90%, preparation method similar embodiment 1, wherein porosity and aperture Pass through Content of Pore-forming Agents and size controlling.
With reference to the same method test of embodiment 1, obtaining unit volume absorption energy when embodiment strain reaches 50% is 0.71×10-3 J/mm3。
Dog Implantation Test is carried out with reference to the same method of embodiment 1, porous tantalum is implanted into cheekbone, the results showed that, it is postoperative more The defects of hole tantalum is not cracked, damaged, 12 weeks after operation bone tissue grow into 36%, and bone tissue grows into 52% within 14 weeks, illustrates with energy The increase of absorption value is measured, bone tissue grows into degree increase, and osteanagenesis effect is more preferable.
Embodiment 3
It is insertion between the vestibule and vestibule of the porous tantalum of the present embodiment, the vestibule of porous tantalum is more with extraneous and insertion The aperture of the vestibule of hole tantalum is 400-500 μm, porosity 85%, preparation method similar embodiment 1, wherein porosity and aperture Pass through Content of Pore-forming Agents and size controlling.
With reference to the same method test of embodiment 1, obtaining unit volume absorption energy when embodiment strain reaches 50% is 0.11×10-2J/mm3。
Dog Implantation Test is carried out with reference to the same method of embodiment 1, porous tantalum is implanted into cheekbone, the results showed that, it is postoperative more The defects of hole tantalum is not cracked, damaged, 12 weeks after operation bone tissue grow into 79%, and bone tissue grows into 100% within 14 weeks, covers with completely, Illustrate the further raising with energy absorption value, bone tissue, which grows into degree, further to be increased, and all covers with implant, osteanagenesis Effect is more preferable.

Claims (3)

1. a kind of porous tantalum, the material body of the porous tantalum is formed by vestibule and around the cavity wall of vestibule, and vestibule is insertion, its It is characterised by：The porosity of the porous tantalum is not more than 95%, when strain reaches 50% still in plateau stress stage, unit bodies Product absorbs energy and is not less than 3.5 × 10 when strain reaches 50%-4 J/ mm3。
2. porous tantalum as claimed in claim 1, it is characterised in that：The porosity of the porous tantalum is not more than 90%, and aperture is 400-500 μm, unit volume absorbs energy and is not less than 0.70 × 10 when strain reaches 50%-3J/mm3。
3. porous tantalum as claimed in claim 1, it is characterised in that：The porosity of the porous tantalum is not more than 85%, and aperture is 400-500 μm, unit volume absorbs energy and is not less than 0.10 × 10 when strain reaches 50%-2J/mm3 。
CN201610834435.5A 2016-09-19 2016-09-19 A kind of porous tantalum Withdrawn CN107841646A (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102205144A (en) * 2010-03-31 2011-10-05 重庆润泽医疗器械有限公司 Porous tantalum serving as medical metal implanted material and preparation method thereof
US20120323323A1 (en) * 2011-06-16 2012-12-20 Zimmer, Inc. Micro-alloyed porous metal having optimized chemical composition and method of manufacturing the same
CN105855553A (en) * 2016-03-30 2016-08-17 山东省立医院 Preparation method of porous tantalum material for mouth cavity implantation

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102205144A (en) * 2010-03-31 2011-10-05 重庆润泽医疗器械有限公司 Porous tantalum serving as medical metal implanted material and preparation method thereof
US20120323323A1 (en) * 2011-06-16 2012-12-20 Zimmer, Inc. Micro-alloyed porous metal having optimized chemical composition and method of manufacturing the same
CN105855553A (en) * 2016-03-30 2016-08-17 山东省立医院 Preparation method of porous tantalum material for mouth cavity implantation

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
王军等: "泡沫浸渍法制备小梁金属及性能", 《中南大学学报(自然科学版)》 *

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Application publication date: 20180327