RU2218242C2 - Method for making medical implants from biologically compatible materials - Google Patents
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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Изобретение относится к технологии лазерного синтеза объемных изделий (ЛСОИ), в том числе к способам скоростного изготовления из порошковых материалов точных биосовместимых пористых медицинских имплантатов для протезирования, в том числе с внутренними пустотами, методом селективного лазерного спекания (СЛС) порошковых композиций. The invention relates to a technology for laser synthesis of bulk products (SALI), including methods for high-speed production of powder materials of accurate biocompatible porous medical implants for prosthetics, including with internal voids, by the method of selective laser sintering (SLS) of powder compositions.
Известны результаты многочисленных работ /см. например труды Всесоюзной научной конференции "Сверхупругость, эффект памяти формы и их применение в новой технике". Тезисы докладов, Томск, 1985/, в которых раскрываются широкие перспективы по использованию в качестве биосовместимого материала для медицинских имплантатов интерметаллида - никелида титана (NiTi), обладающего даже в пористом состоянии крайне полезным для медицины свойством памяти формы. Традиционно никелид титана получают как минимум двойным переплавом расходуемого электрода в вакуумно-дуговой печи или в режиме самораспространяющегося высокотемпературного синтеза (СВС) горения порошковой смеси Ni и Ti. Использование данных методик получения этого материала для нужд медицины имеет существенный недостаток - трудоемкость процесса создания функциональных медицинских имплантатов с заранее заданными индивидуальными форморазмерами. Сам материал также оказывается загрязнен примесями из-за выгорания и ликвации компонентов, что ухудшает параметры формовосстановления и другие свойства этого интерметаллида. The results of numerous works / cm are known. for example, the proceedings of the All-Union Scientific Conference "Superelasticity, the effect of shape memory and their application in new technology." Abstracts, Tomsk, 1985 /, which disclose broad prospects for using intermetallide - titanium nickelide (NiTi) as a biocompatible material for medical implants, which even has a form-memory property that is extremely useful for medicine. Traditionally, titanium nickelide is produced by at least double remelting of a consumable electrode in a vacuum arc furnace or in the mode of self-propagating high-temperature synthesis (SHS) of burning a powder mixture of Ni and Ti. The use of these methods of obtaining this material for the needs of medicine has a significant drawback - the complexity of the process of creating functional medical implants with predetermined individual sizes. The material itself also appears to be contaminated with impurities due to burnout and segregation of components, which worsens the parameters of the form restoration and other properties of this intermetallic compound.
Наиболее близкими к заявляемому изобретению прототипом является способ изготовления объемных изделий из порошковой композиции (Шишковский И. В., Куприянов Н. Л. Патент РФ 2145269, B 22 F 3/105), включающий последовательное послойное размещение порошковой композиции в станке для СЛС, обработку каждого слоя лазерным излучением (ЛИ) по заданному контуру и извлечение полученного изделия из станка с удалением порошковой композиции, не принявшей участия в формировании объемного изделия. По этому способу возможно изготовление изделий из металлполимерных порошковых композиций путем реализации процесса жидкофазного спекания. Closest to the claimed invention, the prototype is a method of manufacturing bulk products from a powder composition (Shishkovsky I.V., Kupriyanov N.L. RF Patent 2145269, B 22 F 3/105), including sequential layer-by-layer placement of the powder composition in the machine for SLS, processing each layer by laser radiation (LI) along a given contour and extracting the obtained product from the machine with the removal of the powder composition, which did not take part in the formation of the bulk product. By this method, it is possible to manufacture products from metal-polymer powder compositions by implementing a liquid phase sintering process.
Следующим логичным шагом является синергетическое совмещение процессов СЛС и СВС новых интерметаллидных фаз в контролируемом ЛИ пространстве. Формирование из порошков Ni и Ti в едином технологическом процессе интерметаллидной фазы - пористого никелид титана позволяет рекомендовать такой процесс для создания медицинских имплантатов заданных индивидуальных форм с использованием методов трехмерного компьютерного моделирования. The next logical step is the synergistic combination of the SFS and SHS processes of new intermetallic phases in controlled LI space. The formation of Ni and Ti powders in a single technological process of the intermetallic phase - porous titanium nickelide allows us to recommend such a process for creating medical implants of specified individual shapes using three-dimensional computer simulation methods.
Задачей заявляемого изобретения является реализация скоростного синтеза пористых функциональных медицинских имплантатов заданных индивидуальных форм методом СЛС из предлагаемой порошковой композиции Ni - Ti. The task of the invention is the implementation of high-speed synthesis of porous functional medical implants of predetermined individual forms by the SLS method of the proposed powder composition Ni-Ti.
Поставленная задача достигается тем, что в способе изготовления медицинских имплантатов заданных индивидуальных форм из биосовместимых материалов методом селективного лазерного спекания порошковых композиций, включающем последовательное послойное размещение порошковой смеси, обработку каждого слоя сканирующим лазерным излучением, в качестве исходной порошковой композиции используют смеси металлических порошков на основе никеля и титана при их весовом соотношении 1:1 с реализацией контролируемой лазерным излучением реакции самораспространяющегося высокотемпературного синтеза пористой интерметаллидной фазы - никелида титана (NiTi) в защитной газовой среде. This object is achieved by the fact that in the method of manufacturing medical implants of predetermined individual forms from biocompatible materials by the method of selective laser sintering of powder compositions, including sequential layer-by-layer placement of the powder mixture, processing of each layer with scanning laser radiation, nickel-based metal powder mixtures are used as the initial powder composition and titanium at a weight ratio of 1: 1 with the implementation of a self-controlled laser radiation reaction the spreading high-temperature synthesis of the porous intermetallic phase - titanium nickelide (NiTi) in a protective gas environment.
При этом для повышения биосовместимости синтезированных медицинских имплантатов исходная смесь порошков никеля и титана дополнительно содержит гидроксиаппатит (-акрилат). Moreover, to increase the biocompatibility of the synthesized medical implants, the initial mixture of nickel and titanium powders additionally contains hydroxyappatite (α-acrylate).
При этом для ускорения процесса вживления в поры синтезированных медицинских имплантатов инфильтруют биостимулирующие добавки. At the same time, biostimulating additives are infiltrated into the pores of the synthesized medical implants to accelerate the process of implantation.
Защитная среда позволяет избежать окисления частиц титана. Предварительное просеивание смешиваемых порошков необходимо для усреднения гранулометрического состава, что улучшает однородность материала изготавливаемого имплантата. При этом важно выбирать размер фракции (дисперсность) обрабатываемого порошка так, чтобы она была соизмерима или меньше диаметра пятна ЛИ. Этим достигается одновременное воздействие ЛИ на несколько частиц порошковой смеси, что обеспечивает их надежное сцепление в процессе реакции контролируемого горения. С другой стороны, соотношение размеров каждой фракции в смеси предпочтительно подбирать так, чтобы частицы титана несколько превосходили по размеру частицы никеля. Это связано с тем, что диффузия из более мелких частиц Ni в сторону частиц Ti происходит активней в контролируемой ЛИ реакции СВС интерметаллида, поскольку коэффициент диффузии Ni больше чем соответствующий коэффициент диффузии Ti. Крупно зернистость частиц Ti по сравнению с частицами Ni минимизирует также его неблагоприятную химическую активность со следами остатков газов - О2, N2, Н3, которые могут оказаться в защитной среде по тем или иным причинам. Использование хорошо апробированной СВС композиции Ni:Ti стехиометрического состава 1:1 позволяет обеспечить не просто спекание порошинок друг с другом, но и одновременно синтезировать интерметаллидную фазу - никелид титана NiTi. Его высокая биосовместимость и возможность использования в медицине достоверно доказана в многочисленных публикациях. Экзотермичность реакции горения СВС композиции вносит дополнительный энерговклад в зону лазерного воздействия (ЛВ). С учетом высокой поглощательной способности металлических систем на длинах волн технологических лазерных установок, интервал оптимальных режимов комбинированного процесса СЛС и СВС практически не смещается в область более высоких плотностей мощности ЛИ, что позволяет уменьшить деформации формы имплантата и избежать его расслоения.The protective environment avoids the oxidation of titanium particles. Preliminary screening of the mixed powders is necessary to average the particle size distribution, which improves the uniformity of the material of the manufactured implant. It is important to choose the size of the fraction (dispersion) of the processed powder so that it is comparable or less than the diameter of the spot LI. This achieves the simultaneous effect of LI on several particles of the powder mixture, which ensures their reliable adhesion during the controlled combustion reaction. On the other hand, the size ratio of each fraction in the mixture is preferably selected so that the titanium particles are slightly larger than the nickel particles. This is due to the fact that diffusion from smaller Ni particles toward Ti particles occurs more actively in the LI controlled SHS reaction of the intermetallic compound, since the diffusion coefficient of Ni is greater than the corresponding diffusion coefficient of Ti. Coarse-grained Ti particles as compared to Ni particles also minimize its unfavorable chemical activity with traces of gas residues - О 2 , N 2 , Н 3 , which can be in a protective environment for one reason or another. The use of a well-tested SHS composition of Ni: Ti stoichiometric composition 1: 1 allows not only sintering the powders with each other, but also at the same time synthesize the intermetallic phase - titanium nickelide NiTi. Its high biocompatibility and the possibility of use in medicine are reliably proven in numerous publications. The exothermicity of the combustion reaction of the SHS composition makes an additional energy input into the zone of laser exposure (LP). Given the high absorption capacity of metal systems at the wavelengths of technological laser systems, the interval of optimal modes of the combined SLS and SHS process practically does not shift to the region of higher power densities of the laser radiation, which allows to reduce the deformation of the shape of the implant and to avoid delamination.
Как известно, процесс СВС может протекать либо в режиме неконтролируемого теплового взрыва, либо в поддающемся контролю диффузионном режиме горения, характеризующемся стационарным распространением волны синтеза. Поскольку ЛСОИ требует прецизионного селективного воздействия на порошковую композицию с целью послойного синтеза строго заданной формы имплантата, принципиальным является выбор параметров ЛВ (плотность мощности ЛИ, скорость сканирования луча, диаметр пятна фокусировки, коэффициент его перекрытия) такими, чтобы имел место именно диффузионный режим. В условиях экзотермичности реакции СВС это достигается экспериментальным подбором, например, скорости сканирования ЛИ, при прочих фиксированных параметрах ЛВ. Визуально реакция горения при оптимальной скорости сканирования должна наблюдаться лишь в зоне прохода лазерного луча. As is known, the SHS process can proceed either in an uncontrolled thermal explosion mode or in a controlled diffusion combustion mode characterized by stationary propagation of a synthesis wave. Since SALF requires a precise selective effect on the powder composition in order to layer-by-layer synthesis of a strictly defined implant shape, it is important to choose the parameters of the drug (power density of the laser beam, scanning speed of the beam, diameter of the focus spot, coefficient of overlap) so that the diffusion mode takes place. Under the exothermicity of the SHS reaction, this is achieved by experimental selection, for example, of the scanning speed of the LI, with other fixed parameters of the drug. Visually, the combustion reaction at the optimum scanning speed should be observed only in the zone of passage of the laser beam.
Для заявляемого изобретения характерен следующий отличительный признак. Формирование биосовместимых функциональных медицинских пористых имплантатов заданных индивидуальных форм реализуется путем синергетического совмещения СЛС и СВС процессов. Управление этим сложным комбинированным процессом надежно осуществляется необходимым изменением параметров ЛВ. Никелид титана, в том числе и в пористом виде, обладает известным свойством памяти формы. Наличие этого свойства при синтезе методом СЛС медицинских имплантатов позволяет перевести на качественно новый уровень ортопедию путем создания самосрабатывающих, самофиксирующихся, саморазворачивающихся протезных элементов при температуре живого организма. Наличие пористости здесь может оказаться еще одним положительным фактором, так как позволяет обеспечить прорастание мягких тканей в имплантат, инфильтровать поры стерилизующими препаратами, способствовать повышению биологической совместимости и активизировать процесс заживления. For the claimed invention is characterized by the following distinguishing feature. The formation of biocompatible functional medical porous implants of predetermined individual forms is realized by synergistic combination of SLS and SHS processes. The management of this complex combined process is reliably carried out by the necessary change in the parameters of the drug. Titanium nickelide, including in a porous form, has a well-known property of shape memory. The presence of this property during the synthesis by the SLS method of medical implants allows to translate orthopedics to a qualitatively new level by creating self-working, self-fixing, self-unfolding prosthetic elements at a temperature of a living organism. The presence of porosity here may turn out to be another positive factor, since it allows the soft tissue to grow into the implant, infiltrate the pores with sterilizing agents, help increase biological compatibility and activate the healing process.
Предлагаемый способ реализован следующим образом. The proposed method is implemented as follows.
Пример 1. Порошки предварительно просеивались на системе сит 005-05 (ГОСТ 3584-73). Наплавочный порошок ПГ-СР4 на основе (Ni, Cr, В, Si сплава) с размером фракции <50 мкм смешивали механически с порошком титана марки ПТОМ с размером фракции <40 мкм в весовой пропорции 1:1 до равномерного распределения. Совмещение СЛС и СВС процессов осуществлялось в операционном поле лазерной установки КВАНТ-60 при параметрах ЛИ: мощность ЛВ Р=10,8-14,7 Вт, скорость сканирования лазерного луча v=2-3 см/с, диаметр пятна ЛИ d=50 мкм. ЛСОИ на основе интерметаллида NiTi реализовывался в среде защитного газа Аr при компьютерном управлении процессом. Example 1. Powders were pre-sieved on a sieve system 005-05 (GOST 3584-73). PG-CP4 surfacing powder based on (Ni, Cr, B, Si alloy) with a fraction size <50 μm was mixed mechanically with PTOM grade titanium powder with a fraction size <40 μm in a weight ratio of 1: 1 until uniform distribution. The combination of SLS and SHS processes was carried out in the operating field of the KVANT-60 laser unit with LI parameters: LV power Р = 10.8-14.7 W, laser beam scanning speed v = 2-3 cm / s, LI spot diameter d = 50 microns. SALS based on the NiTi intermetallic compound was implemented in a protective gas Ar with computer control of the process.
Пример 2. Процесс реализовывался по примеру 1 с использованием в качестве исходных компонент порошка никеля ПНК 1 с размером фракции <40 мкм и порошка титана марки ПТХ с размером фракции <45 мкм, смешиваемых механически в весовой пропорции 1:1. Example 2. The process was carried out as in example 1, using PNK 1 nickel powder as a starting component with a fraction size <40 μm and PTX grade titanium powder with a fraction size <45 μm, mixed mechanically in a weight ratio of 1: 1.
Изменение марок исходных порошковых компонент смеси отражается на полноте протекания реакции синтеза основного продукта - никелида титана. Так в примере 1 синтез NiTi достигал практически 100%, тогда как при исходном составе порошков в примере 2 в спеченном 3-х мерном изделии рентгенофазовым анализом выявляется образование и других интерметаллидных фаз - NiTi2, Ni3Ti.The change in the grades of the initial powder components of the mixture is reflected in the completeness of the synthesis of the main product - titanium nickelide. Thus, in Example 1, NiTi synthesis reached almost 100%, while with the initial composition of the powders in Example 2, the formation of other intermetallic phases — NiTi 2 , Ni 3 Ti — is revealed in the sintered 3-dimensional product by X-ray analysis.
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