JP5311457B2 - Molding method and a sliding member for a prosthesis which is molded by the method of artificial joint sliding element - Google Patents

Molding method and a sliding member for a prosthesis which is molded by the method of artificial joint sliding element Download PDF

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JP5311457B2
JP5311457B2 JP2008161372A JP2008161372A JP5311457B2 JP 5311457 B2 JP5311457 B2 JP 5311457B2 JP 2008161372 A JP2008161372 A JP 2008161372A JP 2008161372 A JP2008161372 A JP 2008161372A JP 5311457 B2 JP5311457 B2 JP 5311457B2
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直秀 富田
孝一 藏本
邦彦 藤原
靖雄 宅間
聡 寺村
康 大久保
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ナカシマメディカル株式会社
直秀 富田
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本発明は、膝関節や股関節に置換される人工関節に用いられる超高分子量ポリエチレンからなる摺動部材の成形方法及びこの方法で成形される人工関節用摺動部材に関するものである。 The present invention relates to a molding method and the sliding member for a prosthesis to be molded in this way of a sliding member made of ultra high molecular weight polyethylene used in the artificial joint to be replaced in the knee or hip.

人工関節は、一対の可動部材が互いに摺動するものであるが、一方は金属やセラミックといった部材で構成され、もう一方は金属やセラミックと摺動相性のよい樹脂で構成されるのが一般的である。 Artificial joint is one in which a pair of movable members slide together, one is composed of members such as metal or ceramic, for the other is made of metal or ceramic and sliding good compatibility resins generally it is. この樹脂は、靱性と粘性に優れる超高分子量ポリエチレン(以下、UHMWPE)が多く用いられる。 This resin is ultra-high molecular weight polyethylene which is excellent in toughness and viscosity (hereinafter, UHMWPE) is often used. この場合、UHMWPEには、摺動による摩耗が生じる他に酸素と反応して酸化する。 In this case, the UHMWPE, oxidized by reacting with oxygen in addition to abrasion due to sliding occurs. また、関節に置換されて使用されている間にも体液等と反応して酸化する。 Also oxidation react with body fluids or the like while being replaced in the joint is used.

酸化が起ると、UHMWPEが劣化してUHMWPE粒子相互或いは相手方部材との間で界面破壊を引き起こすことが知られている。 When oxidation occurs, are known to cause interfacial failure between the UHMWPE is deteriorated UHMWPE particles mutually or thrust bearing. この破壊は、荷重と相関性があり、荷重が大きいほど大きな破壊を起こすことから、股関節や膝関節において問題となる。 This destruction is correlative with a load, since it causes a large disruption higher load is large, a problem in the hip and knee joints. このため、酸化抑制の手段が種々試みられて来たが、下記特許文献1では、UHMWPEにビタミンE(以下、VE)を0.001〜10Wt%添加することが提案されている。 Therefore, although means of the oxidation suppression came been various attempts, in Patent Document 1, UHMWPE vitamin E (hereinafter, VE) has been proposed that the addition of 0.001 to 10%. これによると、VEには顕著な酸化抑制効果があり、かつ、人体に無害であることから、好適な添加物質である旨が述べられている。 According to this, the VE has remarkable oxidation inhibiting effect, and, because it is harmless to the human body, that is a preferred additive material is described.

一方で、UHMWPEは、高温下での流動性が低くて成形性がよくないことも知られている。 On the other hand, UHMWPE has fluidity at high temperatures it is also known in the moldability is poor low. UHMWPEを特定の形状に成形するには、通常は、型によるプレス成形で成形するが、成形性が悪いと、成形する形状に制約を受けたりすることがある。 To mold the UHMWPE to a specific shape, typically it is molded by press molding with the mold, Poor moldability and may or restricted in shape to mold. そこで、本発明者等は成形性の向上に努めて来たが、VEはUHMWPE粒子同士及び成形型との流動を容易にすることを見出して成形性を向上させるとともに、この成形を減圧下で行えば、更に一層の成形性が向上できることがわかり、下記特許文献2として提案している。 Accordingly, the present inventors have come efforts to improve moldability, with VE improve formability found to facilitate the flow of the UHMWPE particles with each other and the mold, the molded under reduced pressure by performing found to be capable of further improving further the moldability is proposed as the following patent document 2.

しかし、VEを添加したUHMWPEは酸化が抑制されて界面破壊を引き起し難いとはいっても、相手方金属やセラミックとたえず摺動するから、それに伴って摩耗し、摩耗粉を発生させる。 However, UHMWPE with added VE can be said that hardly oxidized is suppressed cause interfacial failure, because to constantly sliding with the counterpart metal or ceramic, worn with it, to generate abrasion powder. そこで、下記非特許文献1では、VEが無添加のものと0.3Wt%添加したものとの比較の下で摩擦回数と摩耗粉の発生の関係を調べたものが報告されている。 Therefore, in the following Non-Patent Document 1, VE has been reported that examined the relationship between the occurrence of the lower friction times the abrasion powder of comparison and addition as a 0.3 wt% of the additive-free. これによると、VEが添加されたものの方が無添加のものに比べて摩耗粉の発生が少ないことが示されており、その差は摩擦回数が多いほど大きくなっている。 According to this, towards which VE is added has shown that the generation of abrasion powder is smaller than that of no addition, the difference is greater the larger the friction times.

ところで、発生した摩耗粉は摺動面に留まらず周囲に拡散し、金属又はセラミックと骨との境界面にも浸透して行く。 Meanwhile, the generated abrasion powder is diffused around not only on the sliding surface, it also penetrates the boundary surface between the metal or ceramic and bone. 生体内に摩耗粉が存在していると、これを捕食するマクロファージが寄集して来ることが知られており、マクロファージはサイトカイン(TNFα等)を産出し、サイトカインは骨の吸収に関与しているといわれている。 If wear powder in the body is present, it has been known that macrophages prey come to Yadorikishu and macrophages produce cytokines (TNF [alpha], etc.), cytokines involved in bone resorption It is said that there.

この結果、金属やセラミックと接する骨が溶解し、人工関節が強度を保てずにグラグラする、所謂、ルーズニングという現象を呈すことがある。 As a result, dissolved bone in contact with the metal or ceramic, artificial joints is loose without keep the strength, so-called, may Teisu the phenomenon loosening. ルーズニングが生ずると、場合によっては、再手術が必要なことがある。 When loosening occurs, in some cases, re-operation is necessary. 再手術ということになれば、患者、特に、高齢者にとっては多大な負担となる。 When it comes to re-surgery, the patient, in particular, becomes a heavy burden for the elderly.
特開平11−239611号公報 JP 11-239611 discloses 特開2001−212837号公報 JP 2001-212837 JP

本発明は、以上の課題を解決したものであり、要するに、VEを均一に分散させたUHMWPEを素材として人工関節用摺動部材を製作すれば、摩耗粉にもVEは均一に含まれることになり、この均一化が高いほどVEの作用による蛋白等の隣在物質への表面吸着が制御されることがわかったのである. The present invention has solved the above problems, in short, if manufacturing the sliding member for a prosthesis of UHMWPE prepared by uniformly dispersing the VE as a material, VE to abrasion powder to be included in the uniform will, than is surface adsorption to an adjacent standing substances of protein or the like was found to be controlled by the action of higher this uniform high VE. 蛋白等の表面吸着が制御されると、当然ながらマクロファージによる捕食も少なくなり、ルーズニングが抑制される。 When the surface adsorption of the proteins and the like are controlled, even less predation course macrophages, loosening is suppressed. さらに、VEには炎症抑制作用があり、この作用に基づいて摩耗紛の生物活性が抑制されることも判明し、この効果からもルーズニングの抑制が期待できる。 Further, the VE has anti-inflammatory effect was found also that the biological activity of the wear powder can be suppressed on the basis of this effect can be expected inhibition of loosening from the effects.

以上の課題の下、本発明は、請求項1に記載した、所定の形状に成形されて相手方金属又はセラミックと摺動する超高分子量ポリエチレンからなる人工関節用摺動用部材の成形方法において、 粒子状の超高分子量ポリエチレンにビタミンEを0.01〜0.3Wt%添加するとともに、成形中に 80〜140℃の温度で少なくとも30分保持してビタミンEを超高分子量ポリエチレン中に均一に分散させる均一分散化処理を行うことを特徴とする人工関節用摺動用部材の成形方法を提供するとともに、これにおいて、請求項2に記載した、成形及び均一分散化処理を一定の減圧下又は不活性ガス雰囲気内で行う手段を提供する。 Under the above object, the present invention is set forth in claim 1, in the molding method of a predetermined molded into shape mating metal or ceramic and the sliding is made of ultra high molecular weight polyethylene prosthesis for sliding member, particles to Jo ultra high molecular weight polyethylene with vitamin E added 0.01~0.3Wt%, uniformly dispersed in ultra high molecular weight polyethylene and vitamin E by at least 30 minutes holding at a temperature of 80 to 140 ° C. during the molding while providing method of forming a prosthesis for sliding member which is characterized in that the homogeneous dispersion treatment for, in which, according to claim 2, shaping and homogeneous dispersion process the constant vacuum or under an inert It provides a means for performing in a gas atmosphere. また、請求項3に記したように、請求項1及び2の成形方法で成形された人工関節用摺動用部材をを提供する。 Moreover, as noted in claim 3, it provides a sliding member for a prosthesis which is molded in the molding method according to claim 1 and 2.

請求項1の発明、すなわち、VEを添加したUHMWPEを素材として人工関節用摺動部材を成形すると、ビタミンEの炎症抑制作用や表面吸着制御作用により、結果的にルーズニングを抑制するのである。 The invention of claim 1, i.e., when forming the sliding member for a prosthesis a UHMWPE with added VE as the material, the anti-inflammatory effects or surface adsorption control action of vitamin E, is to consequently suppress loosening. これにおいて、VEの添加量はUHMWPEに対して0.01〜0.3Wt%が適切であり、加えて、均一分散化処理を行うと、この効果をより完全にすることが解明できたのである。 In this, the amount of VE is 0.01~0.3Wt% is appropriate for UHMWPE, in addition, when a uniform dispersion treatment, than it was revealed that to this effect more complete . この均一分散化処理がルーズニングの抑制に関与する仕組みについてであるが、一般に、樹脂等の熱可塑性物質は高温であるほど、粒子の流動性、整列性、配向性は向上する。 This uniform dispersion treatment is about how to participate in the suppression of loosening, generally, a thermoplastic material such as resin as the temperature is high, the fluidity of the particles, the alignment properties, orientation is improved. これらが向上すると、これにVEを添加する場合も、高温ほど分散は均一化するのである When these are improved, even if this is added to VE, the dispersion at higher temperatures is to homogenization.

しかし、あまり高温であれば、VEが失活して添加の役割を果さなくなる。 However, if it is too hot, will not play a role of added VE is deactivated. そこで、本発明の手法であるVEを添加したUHMWPEを80〜140℃で30分以上保持するという均一分散化処理がこれを代替するのである。 Therefore, it is the uniform dispersion process of keeping technique UHMWPE prepared by adding VE is the present invention 80 to 140 ° C. for 30 minutes or more to replace it. 実際、この処理を行うと、蛋白等の表面吸着が制限されることが確認されている。 In fact, after this process, the surface adsorption of proteins and the like is limited has been confirmed. さらに、この処理を減圧下や不活性ガス雰囲気中で行うと、分散を促進して均一化をより高めるし、酸化も抑制することが確認されている。 Furthermore, after this process at reduced pressure or an inert gas atmosphere, to improve the uniform to promote dispersion, it has been confirmed that also inhibit oxidation. なお、この処理は、UHMWPEの物理的特性を高め、成形性を向上させるという一面もある。 This process enhances the physical properties of UHMWPE, is also one aspect of improving the formability.

以下、本発明の実施の形態を説明するが、まず、UHMWPEの特性やVEを添加することの意義について説明しておく。 Hereinafter will be described an embodiment of the present invention, first, previously described significance of the addition of characteristics and VE of UHMWPE. ここでいうUHMWPEとは、分子量が300〜650万g/molの範囲のものをいう。 The UHMWPE here, the molecular weight refers to the range of 300 to 6,500,000 g / mol. このようなUHMWPEを使用するのは、これらが稠密性に富んで耐摩耗性、機械的強度に優れているからであるが、難成形性の材料であることが問題である。 The use of such UHMWPE is that they wear resistance rich in compactness, but because has excellent mechanical strength, it is hardly formable materials is a problem.

人工関節用摺動部材に使用するUHMWPEは、医療用に適応されたものである必要があり、これには、Ticona社製のGUR1020、1050があり、これらはいずれもパウダーの形態で市販されているが、ペレット、タブレットの形態のものもある。 The UHMWPE used in artificial joints sliding element, must be one which is adapted to the medical, This has the GUR1020,1050 of from Ticona, it is commercially available either in the form of powder there, but pellets, also in the form of a tablet. そのいずれを使用してもよいが、成形時の熱による溶解性、気泡の生成性、添加物との均一な混合性の観点から、パウダー状のものがもっとも優れている。 As both the may be used, the solubility by heat during molding, generation of bubbles, from the viewpoint of uniform mixing with the additive, those powder form are best.

成形は加圧成形によるが、樹脂を加圧成形するには、加熱下におけるプレスとインジェクションとがあり、そのいずれであってもよいが、種々の形状のものを少量生産するにはプレスによるものの方が適する。 Molding depends on pressing, the resin to compression molding, there is a pressing and injection in the heating under the may be any, but although According to the press to produce a small amount of various shapes it is suitable. 加えて、本例では、この加圧成形を減圧下又は不活性ガス雰囲気内で行うようにしている。 In addition, in this example, the pressure forming as carried out under reduced pressure or in an inert gas atmosphere. UHMWPEを減圧下で成形すると、減圧に基づいてUHMWPEの粒子の流動性が高まり、成形が容易になって成形時間が短縮できるということがわかってきている。 If the UHMWPE molded under reduced pressure, reduced pressure increases the fluidity of UHMWPE particles based on, it has been found that molding can be shortened molding time becomes easy. また、粒子や粒子間に存在する気泡が抜け、残存する酸素量を減らして酸化による弊害を少なくするという効果もあり、残存酸素量を減らす効果からいえば、不活性ガス雰囲気内で成形するのも適する。 Also, omission bubbles existing between the particles and the particles, to reduce the amount of oxygen remaining also effect of reducing the adverse effects of oxidation, speaking from the effects of reducing the residual amount of oxygen, to mold in an inert gas atmosphere also suitable.

さらに、減圧下又は不活性ガス雰囲気内で成形や均一分散化処理をすることは、上記したVEの効果を減殺しないことにも寄与する。 Furthermore, to the molding or homogeneous dispersion treatment under reduced pressure or in an inert gas atmosphere also contributes to not diminish the effect of VE as described above. 加えて、残存酸素量を減少させることは、製品にして使用中の酸化も抑制できるものとなる。 In addition, to reduce the residual oxygen content, also oxidation during use in the product becomes to be suppressed. この他、気泡の抜けによって稠密性が増し、衝撃強度も向上する。 In addition, compactness is increased by omission of the bubble, the impact strength is also improved. この意味から、減圧の程度は大きいほどよいが、0.1気圧以下であっても相当な効果があり、0.01気圧以下であればほぼ十分である。 In this sense, the degree of vacuum is preferably larger, but there are considerable effect even more than 0.1 atm, it is substantially sufficient if more than 0.01 atm.

また、VEを添加すると、成形性が更に優れたものとなる。 Further, the addition of VE, becomes the moldability is further improved. このVEは、和光純薬工業株式会社から日本薬局方トコフェロール(dl−α−TocopherolJ.P)として液状又はパウダー状で市販されており、ここでのVEには、αートコフェロール、βートコフェロール、γートコフェロール、δートコフェロールとこれらの異性体、誘導体、混合物を含む。 The VE is, Wako Pure Chemical Industries, are commercially available in liquid or powder form from the Corporation as Japan Pharmacopoeia tocopherol (dl-α-TocopherolJ.P), the VE of here, α over-tocopherol, β over tocopherol, including γ over tocopherol, [delta] over tocopherols and isomers thereof, derivatives, a mixture. これらVEを添加するのは、ビタミンEの炎症抑制作用や表面吸着制御作用、抗酸化作用を期してのことは勿論のこと、成形時のUHMWPEからなる素材の流動性を高める目的も有する。 The addition of these VE are anti-inflammatory effects or surface adsorption control action of vitamin E, of course it is possible for the sake of antioxidant action, also has the purpose of enhancing the fluidity of the material consisting of UHMWPE during molding. この点で、本発明におけるVEの添加は重要な意義を有し、単なる酸化防止に限らず、摩耗粉の減少及び生物活性の抑制、ひいてはこれを捕食するマクロファージが産出するTNFαを減少せしめ、人工関節のルーズニングを抑制するためでもある。 In this respect, the addition of VE in the present invention has great significance, not only a mere antioxidant, reduction and inhibition of the biological activity of abrasion powder, allowed reducing TNFα that is macrophages that in turn feed on this yields, artificial also because suppressing joint loosening.

UHMWPEに配合するVEの割合は、0.01〜0.3Wt%が適する。 Ratio of VE formulated into UHMWPE is suitably in 0.01~0.3Wt%. 図2は種々の添加量で添加したUHMWPEの板を作製し、その酸化度(カルボニル基、ケトン基の検出)と酸化の浸透深さの関係を示すものであるが、0.01〜0.3Wt%では深部までほぼ一様な酸化抑制効果が見られる。 2 to prepare a plate of UHMWPE were added at various addition amount, the degree of oxidation (carbonyl group, the detection of ketone groups), but shows the penetration depth of the relationship oxide, from 0.01 to 0. substantially uniform oxidation inhibiting effect to 3 wt% in the deep is seen. しかし、0.005Wt%以下であるとあまり効果がないことが示されている。 However, it has been shown that less effective is not more than 0.005 wt%. なお、0.3Wt%を超える添加量のものについては示されていないが、0.01〜0.3Wt%の範囲ではほとんど差がないことから、これ以上添加したとしても、それほどの有位性は見られないと思われる。 Although not shown for those of the addition amount of more than 0.3 wt%, since there is little difference in the range of 0.01~0.3Wt%, even when added more, less chromatic coordinating It does not appear to be seen. 一方で、酸化抑制と蛋白の吸着及び摩耗粉の発生とは相関していることは明らかであるので、蛋白吸着の抑制に基づくルーズニングの抑制を目的とするVEの添加の割合も上記した範囲のものが適する。 On the other hand, since the occurrence of adsorption and abrasion powder of the oxidation control and protein it is clear that correlates, range rate of addition of the VE for the purpose of suppression of loosening based on the suppression of protein adsorption was also the It is suitable ones.

UHMWREに対するVEの添加の方法は、成形前のUHMWREにVEを添加して混合すればよい。 The method of addition of VE for UHMWRE may be mixed by adding VE to UHMWRE before molding. この混合は、VEの分布を均一にするために室温〜80℃で行うが、VEの浸透性を考えれば、高い温度で行うのが望ましい。 The mixing is carried out at room temperature to 80 ° C. in order to equalize the distribution of VE, given the permeability of VE, carried out at high temperatures is desirable. しかし、混合時に発熱したりすることもあるので、あまり長時間かけて行うと、VEを失活させる虞があるのは上述のとおりである。 However, since also or heat during mixing, performed over a very long time, there is a possibility to inactivate VE are as described above.

攪拌が終了すると、UHMWPEを一旦溶解させる。 When the agitation is completed, to once dissolve the UHMWPE. この溶解は、UHMWPE粒子の表面を溶解させてその粒子同士を接着させるとともに、この溶解部分にVEを浸透させるものであり、UHMWPEを成形素材とする場合には欠かせない操作である。 The dissolution together to adhere the particles to each other by dissolving surfaces of the UHMWPE particles, which infiltrate VE to the dissolution portion, an operation which is indispensable in the case of the UHMWPE and the molding material. 溶解温度は、UHMWPEが溶解する160〜180℃以上は必要であるが、200℃以上の温度で長時間置いておくと、VEを失活させるから、220℃程度で20分弱加熱するのが適する。 Dissolution temperature is UHMWPE is necessary 160 to 180 ° C. or higher for the dissolution and keep a long time at 200 ° C. or higher, because deactivate the VE, is to heat 20 minutes a little less than about 220 ° C. Suitable.

溶解が完了すると、成形操作に入るのであるが、この成形前、成形中、成形後いずれかで次の処理を行う。 When dissolution is complete, although entering the molding operation, prior to the molding, during molding, the following processing is performed either after molding. それは、VEをUHMWPEの粒子内に均一に分散させる上記した均一分散化処理を行うことであり、摩耗紛の減少及び生物活性を下げるためには不可欠な処理である。 It is to perform uniform dispersion process described above to uniformly disperse the VE in the particles of the UHMWPE, it is an essential process for decreasing the reduction and biological activity of the wear powder. VEは溶解時にUHMWPEの粒子間に取り込まれて分散するが、粒子内への分散を均一にするためにこの処理が必要になるのである。 VE is dispersed is incorporated between the particles of the UHMWPE during dissolution, but is becoming necessary this process in order to equalize the dispersion into particles. 均一分散化はVEが添加されたUHMWPEを所定の温度で所定の時間置くことで可能になる。 Homogeneous dispersion is made possible by placing a predetermined time UHMWPE that VE is added at a predetermined temperature.

UHMWPEの溶解は圧力の小さい状況の下で行うのが適するのは当然であるから、これらの操作・処理は成形前に行うのがもっとも好ましい。 Since dissolution of the UHMWPE is natural that suitable performed under a small situations pressure that these operations and processing are performed before forming the most preferred. ただし、あまり圧力をかけない状況であれば、成形中に行ってもよいことが確認されており、この加熱を成形型で行ってもよく、この場合は、成形時間を短縮できる利点がある。 However, if the situation does not apply excessive pressure, that may be carried out during molding have been identified, may be performed with this heated mold, in this case, there is an advantage of shortening the molding time. また、成形後に行っても効果は得られる。 The effects can be obtained be carried out after molding. さらに、上述したように、この成形を減圧下又は不活性ガス雰囲気中で行えば、一層の好結果が得られる。 Further, as described above, by performing the molding under a reduced pressure or in an inert gas atmosphere, the resulting further successful.

図3は以上の処理をしたUHMWPEの板を作製してこれを金属と摩擦してどれくらい摩耗粉が発生したかをVEの添加量との関係で調べたものであるが(摩耗粉は電子顕微鏡で観察)、0.3Wt%のものは無添加のものに比べて摩耗粉の発生量が少なくなっている。 Although FIG. 3 was investigated how much abrasion powder is generated by rubbing it with a metal to prepare a plate of UHMWPE that the above processing in relation to the amount of VE (wear powder electron microscopy in observation), those of 0.3 wt% is generation of abrasion powder than that of no addition is low. 一方で、3Wt%のものは添加量が多すぎてかえって摩耗粉の発生が増えている。 On the other hand, occurrence of rather to those of the 3 wt% additive amount is too much abrasion powder is increasing. このことから、VEの添加量にも適量があることがわかり、多すぎると、不純物的な働きをしてかえって耐摩耗性、耐強度を低下させるのではないかと思われる。 Therefore, you notice that there is an appropriate amount to the addition amount of the VE, is too large, rather wear resistance impurities workings seems that it would be reducing the Resistant degree. ただ、0.3Wt%は適切であるのは確かである。 However, 0.3Wt% is certainly to be appropriate.

図4はUHMWPE表面に吸着した蛋白質の分布状態を評価したものである。 Figure 4 is obtained by evaluating the distribution of proteins adsorbed on the UHMWPE surface. 実験は血漿蛋白成分の中で最も存在割合の多いアルブミンを用い、実験器具へのアルブミン吸着を抑制するために、MPCポリマーで表面処理された製品を使用し、蛍光色素であるFITCをアルブミンに標識して蛍光顕微鏡で観察した(蛍光観察像の撮影条件は統一してある)。 Labeling experiment using the most existing ratio of greater albumin in plasma protein components, in order to suppress the albumin adsorption to labware, using products that are surface treated with MPC polymer, the FITC is a fluorescent dye to albumin and observed under a fluorescence microscope with (photographing condition of the fluorescence observation image are unified). dl−α−Tocopherolの含有量が増加すると背景のアルブミンの吸着量がほぼ均一に減少している(一部に表面粗さによると思われる不整像が見られる)。 When the content of dl-α-Tocopherol increases the amount of adsorption of albumin in the background is reduced substantially uniformly (irregular image that seems to be due to the surface roughness seen in part).

図5はUHMWPE表面上へのアルブミン吸着量を相対蛍光輝度で定量評価したグラフである。 Figure 5 is a graph quantitatively evaluated albumin adsorption onto UHMWPE surfaces in relative fluorescence intensity. 蛍光観察像の全ピクセルを輝度分類(分解能:8ビット)して平均輝度と標準偏差を算出し、VEを添加しない試料の平均輝度を1として、VE添加試料の輝度と相対比較した。 All pixel intensity sort (resolution: 8 bits) of the fluorescence observation image and calculates an average brightness and standard deviation, as one of the average luminance of the sample without addition of VE, and comparison of the brightness and relative VE added sample. ここに示されるように、VEを添加して分散させた試料では,UHMWPE原材料粒子の大きさである100ミクロン以下のオーダーにおいてもUHMWPE表面への蛋白質の吸着がほぼ均一に抑制されている。 As shown here, the sample is dispersed by the addition of VE, protein adsorption is substantially uniformly suppressed to a size of 100 microns or less of the UHMWPE surface even in the order of UHMWPE raw material particles.

このことは、数十ミクロン以下の摩耗紛の大きさのレベルにおいてもVEが均一に分布していることが窺い知れ、これによって、VEの炎症抑制作用や表面吸着制御作用が最大限に期待できるのである。 This may ask that VE also in magnitude level of several tens of microns or less of the wear powder is uniformly distributed, thereby, anti-inflammatory effects or surface adsorption control action of VE can be expected to maximize than is. VEがUHMWPE中に均一に分散されていないと、UHMWPEの摩耗粉によっては、VEの含有が過小のものもあれば、過大のものもあり、いずれの場合も、VE添加の効果が十分でないことが推察できる。 If VE is not uniformly dispersed in the UHMWPE, by the abrasion powder of UHMWPE, some are contained in the VE is too small, some are excessively large, in any case, the effect of VE addition is not sufficient There can be inferred. 大事なのは、摩耗粉にVEが均一に含有されていることであり、これが蛋白吸着の抑制、発生した摩耗粉の生物活性を下げることに寄与するのである。 What matters is that the VE is uniformly contained in the abrasion powder, which is to contribute to lowering the biological activity of inhibition of protein adsorption, generated abrasion powder.

次に、成形について図面を参照して説明するが、本例のものは成形型によってUHMWPEの溶解とVEの均一分散化(熱)処理をするものであるが、本発明はこれに限定されるものではない。 Will now be described with reference to the drawings molding, those of this example is to uniformly dispersed (heat) treatment of dissolution and VE of UHMWPE by mold, the invention is not limited thereto not. 図1は本発明に係る成形方法を具現するための成形装置の一例の説明図であるが、この装置は、所要の形状の成形空間(雌型)1と成形体(雄型)2とが対向して装設される上下一対の金型3、4とからなり、これら金型3、4を密閉した成形室5内に上下二つの加熱冷却盤6、7で挟んで配置できるように収容する。 Figure 1 is an illustration of an example of a molding device for implementing a molding method according to the present invention, the apparatus, a molding space (female) 1 and the molded body of the required shape (male) 2 and is opposite it a pair of upper and lower molds 3 and 4 Metropolitan being So設 with, accommodated in the molding chamber 5 a sealed these molds 3 and 4 to be placed across the upper and lower two heating cooling platen 6 to. なお、この成形室5には、真空ポンプ(図示省略)に連結される吸気ダクト8が連通されているし、上加熱冷却盤6の上方には加圧器(図示省略)も装備されている。 Note that this molding chamber 5, to the intake duct 8 which is connected to a vacuum pump (not shown) is communicated, above the upper heating and cooling plate 6 pressurizer (not shown) is also equipped.

成形に際しては、まず、成形室5を室温にしておき、上加熱冷却盤6と上金型3を上昇させて成形空間1を露出させ、この空間1にVEを添加して混合したUHMWPEを充填する。 In molding, filling first the molding chamber 5 Leave room temperature, raise the upper heating cooling plate 6 and the upper mold 3 to expose the molding space 1, the UHMWPE adding and mixing VE into the space 1 to. 次いで、上金型3の成形体2が成形空間1に作用するように降ろしてその上に上加熱冷却盤6を載せ、この状態で真空ポンプを作動させて成形室5内の空気を吸引して減圧する。 Then placed on the heating and cooling plate 6 thereon molded body 2 of the upper die 3 is lowered to act on the molding space 1, the air in the molding chamber 5 and the suction by operating the vacuum pump in this state vacuum Te to. なお、成形室5内を減圧にしてから金型3、4や加熱冷却盤6、7を操作するものであってもよい。 Incidentally, the forming chamber 5 may be configured to operate the molds 3 and 4 and heated cooling plate 6 after the vacuum. そして、加熱冷却盤6、7で金型3、4の温度を上げてUHMWPEを溶解させるが、この温度があまり高いとVEを失活させるから、約220℃で20分弱の状況に置いておけばよい。 And while raising the temperature of the mold 3 and 4 are dissolved UHMWPE with heat cooling plate 6, because the temperature to inactivate the VE and too high, at the situation of 20 minutes a little less than about 220 ° C. Okebayoi. この雰囲気であれば、VEを失活させないことが確認されている。 If this atmosphere, it has been confirmed that does not deactivate the VE.

以上の溶解処理が終了すると、加熱冷却盤6、7を冷却させて金型3、4の温度を100℃程度に下げ、この状態で少なくとも30分保持する。 When the dissolution process has been completed or, allowed to cool heated cooling plate 6 to lower the temperature of the mold 3 and 4 to approximately 100 ° C. and, at least 30 minutes and held at this state. これによって、VEは溶解したUHMWPEの粒子間に均一に分散される。 Thus, VE is uniformly dispersed between the particles of the UHMWPE dissolved. このときの条件は100℃で30分以上が適当であるが、80〜140℃の温度或いは30分以下の時間でも許容される。 The conditions at this time is more than 30 minutes at 100 ° C. is appropriate, is allowed even temperature or 30 minutes or less of 80 to 140 ° C.. また、これら温度や時間の条件は、成形時の減圧条件又は不活性ガスの充密度によって調整が可能である。 Further, these temperature and time conditions can be adjusted according to the charge density of the vacuum conditions or inert gas during molding.

本発明に係る成形方法を具現するための成形装置の一例の説明図である。 Is an illustration of an example of a molding device for implementing a molding method according to the present invention. VEの種々の添加量に基づく酸化度と酸化の浸透深さの関係を示す特性である。 They are a characteristic showing degree of oxidation and the penetration depth of the relationship oxide based on various amount of VE. 均一分散化処理をしたUHMWPEの板に金属を擦ってどれくらい摩耗粉が発生したかを添加量との関係で見た特性である。 Is how much abrasion powder rub metal plate of the UHMWPE where the homogeneous dispersion process is seen in the relationship between the addition amount or has occurred properties. 均一分散化処理をした各試料表面への端白質吸着状態を示す結果である。 Was uniformly distributed processing is a result indicating Tanshiro quality adsorption state to each sample surface. 均一分散化処理をした各試料表面への蛋白質吸着を定量測定したものの結果である。 The results of those quantified measure protein adsorption to the surface of the sample was uniformly dispersed treatment.

1 成形空間(雌型) 1 molding space (female)
2 成形体(雄型) 2 moldings (male)
3 金型 4 金型 5 成形室5 3 mold 4 mold 5 forming chamber 5
6 加熱冷却盤 7 〃 6 heating cooling plate 7 〃
8 吸気ダクト 8 intake duct

Claims (3)

  1. 所定の形状に成形されて相手方金属又はセラミックと摺動する超高分子量ポリエチレンからなる人工関節用摺動用部材の成形方法において、 粒子状の超高分子量ポリエチレンにビタミンEを0.01〜0.3Wt%添加するとともに、成形中に 80〜140℃の温度で少なくとも30分保持してビタミンEを超高分子量ポリエチレン中に均一に分散させる均一分散化処理を行うことを特徴とする人工関節用摺動用部材の成形方法。 In the molding method of a predetermined molded into shape mating metal or ceramic and consists sliding ultra high molecular weight polyethylene prosthesis for sliding member, 0.01~0.3Wt vitamin E into particles of ultra high molecular weight polyethylene % with the addition of at least 30 minutes holding to a sliding prosthesis and performing uniform dispersion process for uniformly dispersing the vitamin E into UHMWPE at a temperature of 80 to 140 ° C. during the molding method of molding member.
  2. 成形及び均一分散化処理を一定の減圧下又は不活性ガス雰囲気内で行う請求項1の人工関節用摺動用部材の成形方法。 Molding method according to claim 1 of the prosthesis for sliding member for shaping and uniform dispersion treatment within a certain reduced pressure or an inert gas atmosphere.
  3. 請求項1又は2いずれかの方法で成形された人工関節用摺動部材。 Claim 1 or 2 either prosthetic joint sliding element molded by the method.
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