WO2020139103A1 - Cellule cellulaire pour implants - Google Patents

Cellule cellulaire pour implants Download PDF

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Publication number
WO2020139103A1
WO2020139103A1 PCT/RU2018/000871 RU2018000871W WO2020139103A1 WO 2020139103 A1 WO2020139103 A1 WO 2020139103A1 RU 2018000871 W RU2018000871 W RU 2018000871W WO 2020139103 A1 WO2020139103 A1 WO 2020139103A1
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WO
WIPO (PCT)
Prior art keywords
implants
common axis
nodes
cellular structure
openings
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PCT/RU2018/000871
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English (en)
Russian (ru)
Inventor
Юрий Николаевич ЛОГИНОВ
Антон Игоревич ГОЛОДНОВ
Степан Игоревич СТЕПАНОВ
Сергей Владимирович БЕЛИКОВ
Артемий Александрович ПОПОВ
Original Assignee
Акционерное Общество "Наука И Инновации"
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Application filed by Акционерное Общество "Наука И Инновации" filed Critical Акционерное Общество "Наука И Инновации"
Priority to PCT/RU2018/000871 priority Critical patent/WO2020139103A1/fr
Publication of WO2020139103A1 publication Critical patent/WO2020139103A1/fr

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Classifications

    • 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

Definitions

  • the present invention relates to medicine, namely to traumatology and orthopedics.
  • implants used in traumatology and orthopedics which are rod systems and made of titanium or titanium alloys by casting [1] or rolling [2]. They are used mainly for prosthetics of the knee joints.
  • the structure of titanium casting or rolling is a solid (non-porous) metal obtained by casting in vacuum arc remelting furnaces and subsequent pressure treatment, including pressing, forging and rolling, and, if necessary, hot stamping [3].
  • the disadvantage of these implant structures is the absence of pores that can perform several functions. Firstly, the presence of pores reduces the mass of the implant, bringing it closer to the mass of bone material. Secondly, the specific architecture of the location of the pores allows for improved compatibility with bone due to the germination of bone tissue in the pore space. Thirdly, porous structures provide a more acceptable level of physical and mechanical properties for implants: elasticity, damping, etc. [4].
  • patents US2017252165 [5] and RU2576610 [6] propose a group of inventions in which the porous structure of the implant contains a number of branches, each branch having a first end, a second end and a continuous elongated body between said first and second ends, said body having a thickness and length; and contains a number of nodes, and each node contains the intersection of one of the ends of the first branch with the body of the second branches, while in each node no more than two branches intersect.
  • An implant of this design thereby has open porosity, i.e. all its pores communicate with the external environment either by themselves or through neighboring pores.
  • Patents [7, 8] provide for the creation of a surgical implant that provides improved bone compatibility and / or wear resistance.
  • the implant consists of the surface and central areas.
  • the proportion of pore volume within the porous surface region is from 20 to 50%.
  • the pores are interconnected and substantially uniformly distributed within the porous surface region. At least some of the pores have a size in the range from 100 to about 750 microns.
  • the porous surface region has a thickness of at least about 1 mm, and preferably from about 2 to about 5 mm.
  • the core region has a density of 0.7 to 1.0 of the theoretical density.
  • the core region and / or porous surface region are made of titanium, commercial grade titanium, stainless steel, titanium-based alloys, titanium-aluminum-vanadium alloys, titanium-aluminum-niobium alloys, or cobalt-chromium alloys.
  • the core region and / or porous surface region are made of alloys Ti-6A1-4V, Ti-6Al-7Nb, Stellite 211 or stainless steel 316L.
  • a porous biocompatible metal part (orthopedic implant) contains a metal matrix with pores and other material to be extracted. Recoverable material is removed before sintering the first powder metal.
  • the porosity is from 50% to 90%.
  • the disadvantage of this analogue is the irregular appearance of pores and unevenly distributed porosity.
  • the implant has a porous part, which is determined by the set of solid areas where the material is present, and the remaining set of pore areas where the material is absent, the location of at least most of the multiplicity of solid areas is determined by one or more mathematical functions.
  • the nature of the porous part can be systematically changed by changing one or more constants in the mathematical functions, and the part is performed by the process of manufacturing solid free forms.
  • the implant can be represented as a cellular body, the nodes of which are part of stereographic polygons that repeat crystal lattices, for example, diamond.
  • the geometry of pores and jumpers between them was rationalized, which is described in publications [12–15].
  • the closest analogue to the claimed object is the object described in the source [16].
  • the cellular structure of the implants is made in the form of a volumetric lattice with the arrangement of nodes on the surface of spatial figures connected by jumpers.
  • the spatial figure in this case is a cube in which the nodes are connected by rods, and there is no structural material inside the cube. This allows you to create a material with a low density and a sufficiently small modulus of elasticity.
  • a set of spatial figures is made by the method of electron beam sequential deposition, which is one of the methods of additive technologies.
  • the manufacture of a spatial figure in the form of bar systems has one drawback, which is well known in construction.
  • the face of the cube is a square, and a square, unlike a triangle, does not have a sufficiently high rigidity. It can easily be turned under the influence of even a small effort into a rhombus. This cannot be done for figures such as a triangle or a circle. Therefore, the preferred embodiment of the manufacture of the supporting structure is the use of simple planar figures in the form of a triangle or circle. Accordingly, in the volumetric display in the latter case, it will turn out to be a sphere, which was used in the proposed object.
  • the modulus of elasticity is indicated at a density of about 80% at 5.1 GPa. When creating implants, it is desirable to achieve a lower modulus of elasticity, which brings the material closer to the properties of the bone material. Therefore, the disadvantage of the closest analogue is too high modulus of elasticity.
  • the objective of the invention is to improve the elastic properties of implants.
  • the proposed cellular structure of the implants is made in the form of a volumetric lattice with the arrangement of nodes on the surface of spatial figures connected by jumpers.
  • the structure is characterized in that the spatial figure is a hollow ball having a wall, limited by the outer and inner spherical surfaces.
  • the first and second through holes are made having a first common axis, in the plane orthogonal to this axis and at an angle of 45 ° to the first diametrical section, the third and fourth through holes are made having a second common axis.
  • the fifth and sixth holes are made in the same plane, having a third common axis, which is orthogonal to the second common axis. In this case, the holes form the main through channels.
  • On the surface of the hollow ball there are eight nodes located symmetrically with respect to the center of the hollow ball.
  • additional cells are made, communicating with each other by additional channels.
  • Channels in traumatology serve to germinate bone tissue and provide cross paths for the penetration of these tissues.
  • the proposed porous structure for medical implants is preferably made of titanium or a titanium alloy.
  • FIG. 1 shows a General view of the proposed cellular structure
  • Fig. 3 shows the location of the axes of the channels
  • Fig. 4 shows the intersection of the channels.
  • Figure 5 presents the cellular structure with the location of the main channels in the lumen
  • figure 6 is the same in the orthogonal direction.
  • Figure 7 shows the location of the nodes, in fng.8-additional cells.
  • Figure 9 presents the cellular structure with the location of the main and additional channels to the lumen.
  • Figure 10 shows the design diagram of the implant in the form of a rectangular prism based on the proposed cellular structure.
  • 11 shows an enlarged image of the structure with the distribution of equivalent stresses.
  • the proposed cellular structure of the implants is made in the form of a volumetric lattice 1 with the arrangement of nodes on the surface of spatial figures and connected by jumpers (Fig. 1).
  • the spatial figure is a hollow ball 2 (Fig. 2), limited by the outer 3 and inner 4 spherical surfaces, in the first diametrical section of the hollow ball, the first 5 and second b through holes (Fig. 3) are made, having the first common axis 7 (Fig. 2 and 3).
  • the third 8 and fourth (not shown) through holes are made having a second common axis 9
  • the fifth 10 and the sixth (not shown) are made in the same plane ) openings having a third common axis 11, which is orthogonal to the second common axis 9.
  • the presence of through holes and their relative position allows for the appropriate configuration of the main through channels 12 of the cellular structure when viewed along the length of the implant (figure 5), respectively, the main through channels 13 in the orthogonal plane (Fig.6).
  • Channels in traumatology serve to germinate bone tissue and provide cross paths for the penetration of these tissues.
  • nodes On the surface of the hollow ball 2 (Fig.7) there are eight nodes located symmetrically relative to the center of the hollow ball. Six of them with positions 14 ... 19 are shown in the figure and two nodes are in the background. The presence of these nodes is due to the need to join adjacent outer spherical surfaces of hollow balls. However, the presence of massive nodes makes the structure heavier, increases its density, which also increases the modulus of elasticity of the structure. Therefore, in the nodes, additional cells 20 ... 23 are made (Fig. 8), which are interconnected by additional channels 24 and 25.
  • the location of the cells is such that the main channels 12 (Fig. 9) and additional channels 26 are visible in the lumen. This shows that there is a direct path for the germination of additional bone tissue after implantation.
  • Compression loading was modeled by the finite element method in the Mechanical Structure module of the ANSYS software package.
  • the properties of the titanium alloy Ti-6A1-4V are set by constants: density 4430 kg / m 3 ; modulus of elasticity 1 14 GPa; Poisson's ratio 0.342; tensile and compressive yield strength of 780 MPa; tensile strength of 900 MPa and tensile strength of 1100 MPa in compression.
  • FIG. 10 shows an implant in the form of a rectangular prism based on the proposed cellular structure.
  • the structure was loaded with a pressure of 10 MPa and vertical displacements were calculated, the scale of which is shown in the figure on the right.
  • the elastic modulus was calculated from the known pressure and displacements.
  • the variable parameter was the initial relative density, calculated as the ratio of the density of the cellular structure to the density of the material from which it is made.
  • p 0.2, i.e. porosity of 80%
  • 30 GPa is a popular interval of elastic moduli in the field of implant creation.
  • the obtained value of the modulus of elasticity meets the requirements of medical equipment, while it should be borne in mind that the difficulty is obtaining materials with a sufficiently small modulus of elasticity while maintaining strength properties.
  • FIG. 11 shows an enlarged image of a structure with equivalent stress distribution.
  • the figure shows that despite in the presence of thin sections, the maximum stresses reach a relatively low level of 439 MPa, which does not exceed the yield strength of 780 MPa. This proves the efficiency of the proposed design.
  • the proposed cellular structure can be obtained as follows.
  • a computer volumetric model of the implant is created according to the recommendations described in the claims.
  • a cellular structure is made,
  • the technical result of the proposed design of the cellular structure for medical implants is to improve the elastic characteristics of the implants.
  • Patent RU 2397738 Joint prosthesis made of titanium alloy. Application: 2007135065/14, 02.27.2006. Posted: 08/27/2010 Bull. Ns 24.
  • Patent RU 2383654 Nanostructured technically pure titanium for biomedicine and a method for producing a bar from it. IPC C22F 1/18, B82B 3/00. Application: 2008141956/02, 10.22.2008. Published: March 10, 2010. Bull. Ns 7. Valiev R. 3., Semenova I. P., Yakushina E. B., Salimgareeva G. X. Patent holder: Ufa State Aviation Technical University ", NanoMeT LLC.
  • Patent RU2576610 POROUS IMPLANT STRUCTURES. IPC A61L27 / 56. Authors SHARP Jeffrey (US), JANIE Schelesh (US), GILMOR
  • Patent RU 2305514 A method of manufacturing a surgical implant (options) and a surgical implant.
  • Patent US7674426 Porous metal articles having a predetermined pore character.
  • Patent US2011125284 (A1). Publ. 2011-05-26. Improvements in or Relating to Joints and / or Implants. GABBRIELLI RUGGERO, TURNER IRENE GLADYS, BOWEN CHRISTOPHER RHYS, MAGALINI EMANUELE. Applicant (s): they are also UNIVERSITY OF BATH, RENISHAW PLC. IPC: A61F2 / 02; A61F2 / 30; B23P17 / 00. Application US20080994666, 20080908

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Transplantation (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Dispersion Chemistry (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention se rapporte au domaine des techniques additives utilisées dans la fabrication d'implants, de préférence, en alliages de titane. Cette structure cellulaire d'implants se présente sous forme d'une grille volumétrique avec des noeuds disposés sur la surface de figures tridimensionnelles connectées par des ponts. L'invention est caractérisée en ce que la figure tridimensionnelle est une sphère creuse comprenant une paroi délimitée par des surfaces sphériques externe et interne; dans la première section diamétrale, les sphères comportent des première et seconde ouvertures traversantes possédant un axe commun; dans un plan orthogonal à cet axe et à un angle de 45° par rapport à la première section diamétrale sont formées des troisième et quatrième ouvertures possédant un second axe commun, et dans ce même plan sont formées des cinquième et sixième ouvertures ayant un troisième axe commun qui est orthogonal au second axe commun; les ouvertures définissent des canaux traversants principaux et sur la surface de la boule creuse se trouvent huit noeuds disposés symétriquement par rapport au centre de la boule creuse. Les noeuds comportent des cellules supplémentaires communiquant entre elles par des canaux supplémentaires. Le résultat technique de la construction de cette structure cellulaire pour implants médicaux consiste en une amélioration des caractéristiques élastiques.
PCT/RU2018/000871 2018-12-25 2018-12-25 Cellule cellulaire pour implants WO2020139103A1 (fr)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060241776A1 (en) * 2005-04-21 2006-10-26 Biomet Manufacturing Corp. Method and apparatus for use of porous implants
WO2011022560A1 (fr) * 2009-08-19 2011-02-24 Smith & Nephew, Inc. Structures d’implant poreuses
RU2673795C2 (ru) * 2017-04-12 2018-11-30 Федеральное государственное автономное образовательное учреждение высшего образования "Уральский федеральный университет имени первого Президента России Б.Н. Ельцина" Способ производства пористых имплантатов на основе металлических материалов

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060241776A1 (en) * 2005-04-21 2006-10-26 Biomet Manufacturing Corp. Method and apparatus for use of porous implants
WO2011022560A1 (fr) * 2009-08-19 2011-02-24 Smith & Nephew, Inc. Structures d’implant poreuses
RU2673795C2 (ru) * 2017-04-12 2018-11-30 Федеральное государственное автономное образовательное учреждение высшего образования "Уральский федеральный университет имени первого Президента России Б.Н. Ельцина" Способ производства пористых имплантатов на основе металлических материалов

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