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WO2018143841A2 - Bone tissue augmentation for cancellous bone and articular surface replacement - Google Patents

Bone tissue augmentation for cancellous bone and articular surface replacement Download PDF

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Publication number
WO2018143841A2
WO2018143841A2 PCT/RU2018/000040 RU2018000040W WO2018143841A2 WO 2018143841 A2 WO2018143841 A2 WO 2018143841A2 RU 2018000040 W RU2018000040 W RU 2018000040W WO 2018143841 A2 WO2018143841 A2 WO 2018143841A2
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WO
WIPO (PCT)
Prior art keywords
bone
polished
augment
flat surfaces
articular surface
Prior art date
Application number
PCT/RU2018/000040
Other languages
French (fr)
Russian (ru)
Other versions
WO2018143841A3 (en
Inventor
Александр Александрович ВЕТОШКИН
Дмитрий Николаевич БОГОСЛОВСКИЙ
Original Assignee
ПОПОВ, Дмитрий Александрович
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
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Application filed by ПОПОВ, Дмитрий Александрович filed Critical ПОПОВ, Дмитрий Александрович
Publication of WO2018143841A2 publication Critical patent/WO2018143841A2/en
Publication of WO2018143841A3 publication Critical patent/WO2018143841A3/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/28—Bones

Definitions

  • the utility model relates to the field of medicine, namely to orthopedics and can be used to replace bone defects of the cancellous bone.
  • a known implant for replacing a bone defect, containing a layer of grains of porous titanium nickelide further comprises a monolithic part of porous titanium nickelide mounted on the above layer of grains of porous titanium nickelide, forming a spongy part of the implant, while both parts of the implant are pre-saturated with an antibiotic diluted with rich platelet autoplasma (RF patent Ns105584, published 06/20/2011).
  • the closest analogue of the patented product is an element of the tibia of the hip joint made of forged titanium alloy, having a shaft that is designed for cementless insertion into the femur of a human or animal, and which has a porous metal surface obtained by firing and / or in the proximal region fusion, as well as a region with a polished surface (WO2015144129, published 01.10.2015).
  • the technical problem solved by the proposed utility model is to create a new tool for replacing a defect in the spongy bone and part of the articular surface, which is characterized by high survival rate and low trauma for the tissues surrounding the augmented defect.
  • the proposed tool is intended to fill a defect in bone tissue and articular surface with augment made by the additive technology of titanium alloy Ti 6AI 4V.
  • the technical result of the patented solution is to increase the survival rate of the augmentation element of bone tissue with the articular surface by eliminating rejection and additional injury to others tissues, provided by the adhesion of the porous surfaces of the augment element with the walls of the bone defect without the use of cement, negatively acting on the surrounding tissue.
  • the specified technical result is achieved due to the construction of bone augment for replacing the defect in the tubular bone, made using additive technology of titanium alloy Ti 6AI 4V and including curved and flat surfaces, where the flat surfaces are made porous and the curved is polished, and includes two through holes for mounting screws made in such a way that the screw caps are flush with the polished surface.
  • the proposed element is made of a titanium alloy in accordance with GOST R ISO 5832-3-2014 (Implants for surgery. Metallic materials. Part 3. Deformable alloy based on titanium, 6-aluminum and 4-vanadium).
  • the element is made according to individual anthropometric data using the ZR-print method using MSCT and MRI data, while the size of the finished product corresponds to the dimensions of the model obtained in the STL format.
  • the set of essential features of the product is aimed at reducing the invasiveness of tissues surrounding the bone, which increases the likelihood of engraftment of a fragment of a titanium alloy to the bone.
  • Flat surfaces of the structure are made porous, which allows not using cement to adhere the augment to the walls of the bone defect and ensures the gradual ingrowth of living tissue into the augment material.
  • the curved augment surface forming the articular surface is polished, which ensures good sliding of the friction pair in the joint.
  • the screw holes with recesses for the screw caps are made so that the surfaces of the caps are flush with the polished augment surface, which prevents contact of the screw caps in a friction pair.
  • the direction of the holes is designed in such a way as to ensure easy installation of screws in a minimally invasive surgical manner using arthroscopy.
  • the direction of insertion of the screws is perpendicular to the curved articular surface of the augment and is directed to the projection of the center of the bone metaphysis.
  • FIG. 1 - a general view of augmentation of bone tissue.
  • FIG. 2 the position of the screws in the augment.
  • the prosthesis element for replacing bone defects in the tubular bone is made by selective laser melting (SLM) and includes flat surfaces 1 made of porous. Porosity is obtained due to 3D printing by means of layer-by-layer growth of the cellular structure, the unit cell of which is the dodecahedron.
  • the holes 3 are made through and aligned with the screws 5, and also include recesses 4 under the caps of the screws 5 so that the caps of the screws are flush with the polished surface 2 of the part.
  • the overall overall dimensions of the part are individual for each application.
  • Titanium augment is made by the method of ZR-printing of titanium alloy.
  • the printing process begins with the separation of the digital three-dimensional model into layers with a thickness of 20 to 100 microns.
  • the production cycle consists of applying a thin layer of powder on the work surface - usually a metal table that can move in the vertical direction.
  • the printing process takes place in a working chamber filled with inert gases.
  • the lack of oxygen avoids the oxidation of the consumable, which makes printing possible with materials such as titanium.
  • Each layer of the model is fused, repeating the contours of layers of a digital model. Melting is carried out using a laser beam guided along the X and Y axes by two mirrors with a high deflection rate.
  • the power of the laser emitter is high enough to melt the powder particles into a homogeneous material.

Landscapes

  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

The utility model relates to the field of medicine, specifically to orthopaedics, and can be used for replacing cancellous bone defects. The technical result of the solution being patented is an increase in the survival rate of a prosthetic element by preventing rejection and additional traumatization of the surrounding tissues. A bone tissue augmentation is formed from titanium alloy and comprises a curvilinear surface and flat surfaces, wherein the flat surfaces are porous, and the curvilinear surface is polished, and two through openings for fastening screws which are formed such that the screw heads are arranged flush with the polished surface.

Description

АУГМЕНТ КОСТНОЙ ТКАНИ ДЛЯ ЗАМЕЩЕНИЯ ГУБЧАТОЙ КОСТИ И  BONE TISSUE AUGMENT FOR SUBSTITUTION OF SPONGE AND
СУСТАВНОЙ ПОВЕРХНОСТИ  JOINT SURFACE
Полезная модель относится к области медицины, а именно к ортопедии и может быть использована для замещения костных дефектов губчатой кости. The utility model relates to the field of medicine, namely to orthopedics and can be used to replace bone defects of the cancellous bone.
УРОВЕНЬ ТЕХНИКИ  BACKGROUND
Из уровня техники известны следующие технические решения.  The following technical solutions are known from the prior art.
Известен имплантат для замещения костного дефекта, содержащий слой из крупинок пористого никелида титана, дополнительно содержит монолитную часть из пористого никелида титана, установленную на вышеуказанный слой из крупинок пористого никелида титана, образующий губчатую часть имплантата, при этом обе части имплантата предварительно насыщены антибиотиком, разведенным богатой тромбоцитами аутоплазмой (патент РФ Ns105584, опубликован 20.06.2011).  A known implant for replacing a bone defect, containing a layer of grains of porous titanium nickelide, further comprises a monolithic part of porous titanium nickelide mounted on the above layer of grains of porous titanium nickelide, forming a spongy part of the implant, while both parts of the implant are pre-saturated with an antibiotic diluted with rich platelet autoplasma (RF patent Ns105584, published 06/20/2011).
Наиболее близким аналогом патентуемого изделия является элемент протеза берцовой кости тазобедренного сустава, выполненного из кованного титанового сплава, имеющий вал, который предназначен для бесцементной вставки в бедренную кость человека или животного, и который имеет в проксимальной области пористую металлическую поверхность, полученную путем обжига и/или сплавления, а также область с полированной поверхностью (WO2015144129, опубликована 01.10.2015).  The closest analogue of the patented product is an element of the tibia of the hip joint made of forged titanium alloy, having a shaft that is designed for cementless insertion into the femur of a human or animal, and which has a porous metal surface obtained by firing and / or in the proximal region fusion, as well as a region with a polished surface (WO2015144129, published 01.10.2015).
РАСКРЫТИЕ ИЗОБРЕТЕНИЯ  SUMMARY OF THE INVENTION
Техническая проблема, решаемая предлагаемой полезной моделью, заключается в создании нового средства для замещения дефекта губчатой кости и части суставной поверхности, отличающегося высокой приживаемостью и малой травматичностью для тканей, окружающих аугментированный дефект.  The technical problem solved by the proposed utility model is to create a new tool for replacing a defect in the spongy bone and part of the articular surface, which is characterized by high survival rate and low trauma for the tissues surrounding the augmented defect.
Предлагаемое средство предназначено для восполнения дефекта костной ткани и суставной поверхности аугментом, выполненным по аддитивной технологии из титанового сплава Ti 6AI 4V.  The proposed tool is intended to fill a defect in bone tissue and articular surface with augment made by the additive technology of titanium alloy Ti 6AI 4V.
Техническим результатом патентуемого решения является повышение приживаемости элемента аугмента костной ткани с суставной поверхностью за счет исключения отторжения и дополнительного травмирования окружающих тканей, обеспечиваемого сцеплением пористых поверхностей элемента аугмента со стенками костного дефекта без использования цемента, негативно действующего на окружающие ткани. The technical result of the patented solution is to increase the survival rate of the augmentation element of bone tissue with the articular surface by eliminating rejection and additional injury to others tissues, provided by the adhesion of the porous surfaces of the augment element with the walls of the bone defect without the use of cement, negatively acting on the surrounding tissue.
Указанный технический результат достигается за счет конструкции аугмента костной ткани для замещения дефекта трубчатой кости, выполненного по аддитивной технологии из титанового сплава Ti 6AI 4V и включающего криволинейную и плоские поверхности, где плоские поверхности выполнены пористыми, а криволинейная - полированной, и включающего два сквозных отверстия для крепежных винтов, выполненных таким образом, что шляпки винтов располагаются заподлицо с полированной поверхностью.  The specified technical result is achieved due to the construction of bone augment for replacing the defect in the tubular bone, made using additive technology of titanium alloy Ti 6AI 4V and including curved and flat surfaces, where the flat surfaces are made porous and the curved is polished, and includes two through holes for mounting screws made in such a way that the screw caps are flush with the polished surface.
Предлагаемый элемент изготовлен из титанового сплава, соответствующего ГОСТ Р ИСО 5832-3-2014 (Имплантаты для хирургии. Металлические материалы. Часть 3. Деформируемый сплав на основе титана, 6- алюминия и 4-ванадия).  The proposed element is made of a titanium alloy in accordance with GOST R ISO 5832-3-2014 (Implants for surgery. Metallic materials. Part 3. Deformable alloy based on titanium, 6-aluminum and 4-vanadium).
Элемент изготавливается по индивидуальным антропометрическим данным методом ЗР-печати с использованием данных МСКТ и МРТ, при этом размер готового изделия соответствует размерам модели, полученной в формате STL.  The element is made according to individual anthropometric data using the ZR-print method using MSCT and MRI data, while the size of the finished product corresponds to the dimensions of the model obtained in the STL format.
Совокупность существенных признаков изделия направлена на снижение травматичности окружающих кость тканей, что повышает вероятность приживления фрагмента из титанового сплава к кости.  The set of essential features of the product is aimed at reducing the invasiveness of tissues surrounding the bone, which increases the likelihood of engraftment of a fragment of a titanium alloy to the bone.
Плоские поверхности конструкции выполнены пористыми, что позволяет не использовать цемент для сцепления аугмента со стенками костного дефекта и обеспечивает постепенное врастание живой ткани в материал аугмента. Криволинейная поверхность аугмента, образующая суставную поверхность, выполнена полированной, что обеспечивает хорошее скольжение пары трения в суставе. Отверстия под винты с углублениями под шляпки винтов выполнены таким образом, чтобы поверхности шляпок были заподлицо с полированной поверхностью аугмента, что предотвращает контакт шляпки винта в паре трения. Направление отверстий спроектированы таким образом, чтобы обеспечить простую установку винтов малоинвазивным оперативным способом с использованием артроскопии. Направление введения винтов перпендикулярно к криволинейной суставной поверхности аугмента и направлено в проекцию центра метафиза кости. ОПИСАНИЕ ЧЕРТЕЖЕЙ Flat surfaces of the structure are made porous, which allows not using cement to adhere the augment to the walls of the bone defect and ensures the gradual ingrowth of living tissue into the augment material. The curved augment surface forming the articular surface is polished, which ensures good sliding of the friction pair in the joint. The screw holes with recesses for the screw caps are made so that the surfaces of the caps are flush with the polished augment surface, which prevents contact of the screw caps in a friction pair. The direction of the holes is designed in such a way as to ensure easy installation of screws in a minimally invasive surgical manner using arthroscopy. The direction of insertion of the screws is perpendicular to the curved articular surface of the augment and is directed to the projection of the center of the bone metaphysis. DESCRIPTION OF DRAWINGS
Далее решение поясняется ссылками на фигуры, на которых приведено следующее.  Next, the solution is illustrated by reference to the figures, which show the following.
Фиг. 1 - общий вид аугмента костной ткани.  FIG. 1 - a general view of augmentation of bone tissue.
5 Фиг. 2 - положение винтов в аугменте. 5 FIG. 2 - the position of the screws in the augment.
ОСУЩЕСТВЛЕНИЕ ИЗОБРЕТЕНИЯ  DETAILED DESCRIPTION OF THE INVENTION
Элемент протеза для замещения костных дефектов в трубчатой кости выполнен методом выборочной лазерной плавки (SLM) и включает плоские поверхности 1 , выполненные пористыми. Пористость получается за счет 3d ю печати посредствам послойного роста ячеистой структуры, единичная ячейка которой является додекаэдр. Также аугмент включает криволинейную суставную поверхность 2, выполненную полированной. Полировка осуществляется физическим путем, с применением шлифовальных инструментов и полировочной пасты. Аугмент костной ткани фиксируется в области дефекта посредством The prosthesis element for replacing bone defects in the tubular bone is made by selective laser melting (SLM) and includes flat surfaces 1 made of porous. Porosity is obtained due to 3D printing by means of layer-by-layer growth of the cellular structure, the unit cell of which is the dodecahedron. The augment also includes a curved articular surface 2 made of polished. Polishing is carried out physically, using grinding tools and polishing paste. Bone augment is fixed in the area of the defect by
15 винтов 5 в отверстиях 3. Отверстия 3 выполнены сквозными и соосны винтам 5, а также включают углубления 4 под шляпки винтов 5 для того, чтобы шляпки винтов располагались заподлицо полированной поверхности 2 детали. 15 screws 5 in the holes 3. The holes 3 are made through and aligned with the screws 5, and also include recesses 4 under the caps of the screws 5 so that the caps of the screws are flush with the polished surface 2 of the part.
Общие габаритные размеры детали индивидуальны для каждого случая применения.  The overall overall dimensions of the part are individual for each application.
20 Аугмент костной ткани производят следующим образом.  20 Augmentation of bone tissue is as follows.
Пациенту проводят исследование- МРТ или МСКТ, по результатам которых получают параметры костного дефекта. Титановый аугмент изготавливают методом ЗР-печати из титанового сплава. Процесс печати начинается с разделения цифровой трехмерной модели на слои толщиной от 20 до 100 микрон. The patient undergoes an MRI or MSCT study, according to the results of which the parameters of the bone defect are obtained. Titanium augment is made by the method of ZR-printing of titanium alloy. The printing process begins with the separation of the digital three-dimensional model into layers with a thickness of 20 to 100 microns.
25 Готовый файл в стандартном формате STL используется в качестве чертежей для построения физической модели. 25 The finished file in the standard STL format is used as drawings for building a physical model.
Производственный цикл состоит из нанесения тонкого слоя порошка на рабочую поверхность - как правило, металлический стол, способный передвигаться в вертикальном направлении. Процесс печати протекает в рабочей зо камере, заполняемой инертными газами. Отсутствие кислорода позволяет избегать оксидации расходного материала, что делает возможной печать такими материалами, как титан. Каждый слой модели сплавляется, повторяя контуры з слоев цифровой модели. Плавка производится с помощью лазерного луча, направляемого по осям X и Y двумя зеркалами с высокой скоростью отклонения. Мощность лазерного излучателя достаточно высока для плавки частиц порошка в гомогенный материал. The production cycle consists of applying a thin layer of powder on the work surface - usually a metal table that can move in the vertical direction. The printing process takes place in a working chamber filled with inert gases. The lack of oxygen avoids the oxidation of the consumable, which makes printing possible with materials such as titanium. Each layer of the model is fused, repeating the contours of layers of a digital model. Melting is carried out using a laser beam guided along the X and Y axes by two mirrors with a high deflection rate. The power of the laser emitter is high enough to melt the powder particles into a homogeneous material.

Claims

ФОРМУЛА ПОЛЕЗНОЙ МОДЕЛИ USEFUL MODEL FORMULA
Аугмент костной ткани для замещения дефекта губчатой кости и суставной поверхности, характеризующийся тем, что выполнен из титанового сплава посредством выборочной лазерной плавки и включает криволинейную и плоские поверхности, при этом плоские поверхности выполнены пористыми, а криволинейная - полированной, и два сквозных отверстия для крепежных винтов, выполненных таким образом, чтобы шляпки винтов располагались заподлицо с полированной поверхностью аугмента.  Bone tissue augment to replace a defect in the cancellous bone and articular surface, characterized in that it is made of titanium alloy by means of selective laser melting and includes curved and flat surfaces, while the flat surfaces are made porous and the curved is polished, and two through holes for mounting screws made so that the screw caps are flush with the polished augment surface.
PCT/RU2018/000040 2017-02-01 2018-01-29 Bone tissue augmentation for cancellous bone and articular surface replacement WO2018143841A2 (en)

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RU2220682C2 (en) * 2002-01-10 2004-01-10 Ланшаков Виталий Алексеевич Implant for performing making plastic repair of bone defects of bearing articulation surfaces
AU2003261497B2 (en) * 2002-11-08 2009-02-26 Howmedica Osteonics Corp. Laser-produced porous surface
GB0717692D0 (en) * 2007-09-11 2007-10-17 Roberts Paul Acetabular component

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