WO2023115172A1 - Process of manufacturing an acetabular insert - Google Patents

Process of manufacturing an acetabular insert Download PDF

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Publication number
WO2023115172A1
WO2023115172A1 PCT/BR2021/050564 BR2021050564W WO2023115172A1 WO 2023115172 A1 WO2023115172 A1 WO 2023115172A1 BR 2021050564 W BR2021050564 W BR 2021050564W WO 2023115172 A1 WO2023115172 A1 WO 2023115172A1
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WO
WIPO (PCT)
Prior art keywords
acetabular
cavity
insert
polishing
acetabular insert
Prior art date
Application number
PCT/BR2021/050564
Other languages
French (fr)
Portuguese (pt)
Inventor
Daniel STAINER
Original Assignee
Stainer Daniel
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
Publication date
Application filed by Stainer Daniel filed Critical Stainer Daniel
Priority to PCT/BR2021/050564 priority Critical patent/WO2023115172A1/en
Publication of WO2023115172A1 publication Critical patent/WO2023115172A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/32Joints for the hip
    • A61F2/34Acetabular cups

Definitions

  • the present invention refers to a process that is used to manufacture an acetabular insert, which is a prosthesis that is intended for the reconstruction of the acetabulum, which is a concave depression formed in the iliac bone, and which is the place where the head of the femur bone fits together to form the articulation pair, also known as the tribological pair, which is the thigh bone. Since the proposed process results in an acetabular insert with superior quality of surface finish, and also results in superior quality of mechanical resistance against wear, among other advantages.
  • the acetabular inserts so far comprised in the state of the art are produced in ultra high molecular weight polyethylene (UHMW PE), which is supplied by specialized industries, in the form of cylindrical dowels, or else in the form of plates. So that, to obtain the acetabular inserts, the dowels or plates are cut to the necessary sizes, and submitted to the process of machining, where the artificial acetabular cavity is carved in the polyethylene piece by means of special machinery, such as high precision machines in the machining process, such as CNC tomes and CNC milling machines.
  • UHMW PE ultra high molecular weight polyethylene
  • the machining process involves some inconveniences and limitations; the most considerable of them being the fact that the machining of the artificial acetabular cavity results in a surface endowed with considerable micro-roughness, even though it is subjected to mechanical polishing processes, which impacts on the final quality of the prosthesis, as these micro-roughness result, over the course of time of use, in a process of wear between the surface of the cavity of the acetabular insert and the surface of the femoral head prosthesis, with the generation of loose polyethylene particles, also known as Debris, which contaminate the site, endangering the functionality of the prosthesis, and also the health of the patient.
  • loose polyethylene particles also known as Debris
  • a second drawback is the fact that the machining process of the acetabular insert requires a considerably large piece of polyethylene, so that the final piece can be extracted, which implies a great waste of material, which has a high cost and generation of non-recyclable material to the environment, therefore, impacts on the final price of the prosthesis, making it difficult for patients with lower purchasing value.
  • the present invention was developed. Being proposed a process for the manufacture of the acetabular insert, which comprises the injection/pressing of ultra high molecular weight polyethylene (UHMW PE) - in granular form - inside an injection mould/press mould. Since the element of the mold that shapes the acetabular cavity of the insert is made with a very high degree of polishing, obtaining a very low surface roughness in the product that was formed through the high compression force (in Kgf/cm2).
  • UHMW PE ultra high molecular weight polyethylene
  • FIGURE 1 represents an Acetabular Insert in central section
  • FIGURE 2 represents in perspective the part of the Mold that has the element for forming the polished surface of the acetabular insert cavity
  • FIGURE 3 represents in side view the part of the Mold that has the element for forming the polished surface of the acetabular insert cavity; and the FIGURE 4 represents in a top view the part of the Mold that has the element for forming the polished surface of the acetabular insert cavity.
  • MANUFACTURING PROCESS OF Acetabular Insert comprises the use of a special tooling, in high hardness steel, in the form of an injection mold (M) for thermoplastic , whose spherical element (E) that shapes the concave cavity (K) of the resulting acetabular insert (A), has its surface - convex - made with a very high degree of polishing.
  • This mold is driven by a hydraulic injection press, which injects the ultra high molecular weight polyethylene (UHMW PE) in powder form at high temperature - therefore in a state of fusion - and at high pressure, so that , the shaped part - acetabular insert (A) - presents the surface of the acetabular cavity (K) with a very high degree of polishing and free of imperfections, thus generating a finished surface ready to fulfill its final purpose and, therefore, without the need for from any further interference to suitability; only needing a little machining in its posterior portion, for adaptation to the receptacle (not illustrated) that makes the interface with the interior of the original acetabular cavity of the ilium bone.
  • UHMW PE ultra high molecular weight polyethylene
  • the present ACETABULAR INSERT MANUFACTURING PROCESS may present variations in its embodiment; a variety of equipment can be used, as well as a variety of materials, as long as the particular basic characteristics are maintained and which are essential to its realization, mainly the fact that the surface of the cavity (K) of the acetabular insert (A) results in a finished product after injection molding process.

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)

Abstract

The invention relates to a process that is used for the manufacture of an acetabular insert, a prosthesis intended for the reconstruction of the acetabulum, which is a concave depression formed in the iliac bone and is the socket for receiving the femoral head. Said proposed process comprises the use of an injection mould (M) for thermoplastic, having a spherical element (E) that creates the shape of the concave cavity (K) of the resulting acetabular insert (A), the surface of the spherical element being produced with a very high degree of polishing. Said mould is driven by a hydraulic injection press, which injects the ultra-high molecular weight polyethylene (UHMW-PE) in powder form at high temperature - therefore in fusion state - and at high pressure, so that the resulting formed part - acetabular insert (A) - has an acetabular cavity (K) surface with a very high degree of polishing and free of imperfections, thus generating a finished surface ready to fulfill its end purpose.

Description

PROCESSO DE FABRICAÇÃO DE INSERTO ACETABULAR ACETABULAR INSERT MANUFACTURING PROCESS
Campo da invenção field of invention
[001] A presente Invenção se refere a um processo que é empregado para a fabricação de um inserto acetabular, o qual se trata de uma prótese que é destinada à reconstrução do acetábulo, que é uma depressão côncava formada no osso ilíaco, e que é o local de encaixe da cabeça do osso fêmur para formar o par de articulação, também conhecido como par tribológico, que é o osso da coxa. Sendo que, o processo proposto resulta num inserto acetabular com qualidade superior de acabamento superficial, e também resulta em qualidade superior de resistência mecânica contra o desgaste, entre outras vantagens. [001] The present invention refers to a process that is used to manufacture an acetabular insert, which is a prosthesis that is intended for the reconstruction of the acetabulum, which is a concave depression formed in the iliac bone, and which is the place where the head of the femur bone fits together to form the articulation pair, also known as the tribological pair, which is the thigh bone. Since the proposed process results in an acetabular insert with superior quality of surface finish, and also results in superior quality of mechanical resistance against wear, among other advantages.
Estado da técnica state of the art
[002] É conhecido o fato de que algumas condições clínicas, sejam causadas por doenças ou acidentes, impõem a necessidade de reconstrução do acetábulo, que como foi dito anteriormente, se trata daquela formação côncava do osso ilíaco, e que recebe no seu interior a cabeça femoral, como par de atrito, compondo assim a articulação superior da coxa. Sendo que, neste caso, uma das medidas corretivas é a substituição da cavidade acetabular natural por uma prótese, o que exige que a região da cabeça do fêmur também seja substituída por uma prótese, que por sua vez, opera no interior da prótese relativa à cavidade acetabular. [002] It is known that some clinical conditions, whether caused by disease or accidents, require the reconstruction of the acetabulum, which, as mentioned earlier, is the concave formation of the iliac bone, which receives the femoral head, as a friction pair, thus composing the upper joint of the thigh. Since, in this case, one of the corrective measures is the replacement of the natural acetabular cavity by a prosthesis, which requires that the region of the femoral head also be replaced by a prosthesis, which, in turn, operates inside the prosthesis relative to the acetabular cavity.
[003] Por sua vez, os insertos acetabulares até o momento compreendidos no estado da técnica são produzidos em polietileno de ultra alto peso molecular (UHMW PE), o qual é fornecido por indústrias especializadas, na forma de tarugos cilíndricos, ou então na forma de placas. De modo que, para a obtenção dos insertos acetabulares, os tarugos ou placas são cortados nos tamanhos necessários, e submetidos ao processo de usinagem, onde a cavidade acetabular artificial é esculpida na peça de polietileno por meio de maquinário especial, como maquinas de elevada precisão no processo de usinagem, tais como os tomos CNC's e frezadoras CNC's. Sendo que, o processo de usinagem envolve alguns inconvenientes e limitações; sendo o mais considerável deles, o fato de que a usinagem da cavidade acetabular artificial resulta numa superfície dotada de microrrugosidades consideráveis, mesmo sendo submetida a processos de polimento mecânico, o que impacta na qualidade final da prótese, pois estas microrrugosidades resultam, ao longo do tempo de uso, num processo de desgaste entre a superfície da cavidade do inserto acetabular e a superfície da prótese da cabeça femoral, havendo ali a geração de partículas soltas de polietileno, também conhecidas como Debris, as quais contaminam o local, pondo em risco a funcionalidade da prótese, e também a saúde do paciente. [003] In turn, the acetabular inserts so far comprised in the state of the art are produced in ultra high molecular weight polyethylene (UHMW PE), which is supplied by specialized industries, in the form of cylindrical dowels, or else in the form of plates. So that, to obtain the acetabular inserts, the dowels or plates are cut to the necessary sizes, and submitted to the process of machining, where the artificial acetabular cavity is carved in the polyethylene piece by means of special machinery, such as high precision machines in the machining process, such as CNC tomes and CNC milling machines. Since, the machining process involves some inconveniences and limitations; the most considerable of them being the fact that the machining of the artificial acetabular cavity results in a surface endowed with considerable micro-roughness, even though it is subjected to mechanical polishing processes, which impacts on the final quality of the prosthesis, as these micro-roughness result, over the course of time of use, in a process of wear between the surface of the cavity of the acetabular insert and the surface of the femoral head prosthesis, with the generation of loose polyethylene particles, also known as Debris, which contaminate the site, endangering the functionality of the prosthesis, and also the health of the patient.
[004] Um segundo inconveniente é o fato de que o processo de usinagem do inserto acetabular requer um pedaço de polietileno consideravelmente grande, para que se possa extrair a peça final, o que implica em grande desperdício de material, o qual possui alto custo e geração de material não reciclável ao meio ambiente, portanto, impacta no preço final da prótese, dificultando a aquisição por pacientes com menor valor aquisitivo. [004] A second drawback is the fact that the machining process of the acetabular insert requires a considerably large piece of polyethylene, so that the final piece can be extracted, which implies a great waste of material, which has a high cost and generation of non-recyclable material to the environment, therefore, impacts on the final price of the prosthesis, making it difficult for patients with lower purchasing value.
[005] Outro inconveniente que deve ser considerado é o fato de que, por ser obtido pelo processo de extrusão, tanto os tarugos como a placas de polietileno não atingem um grau ótimo de densidade, aumentando sua suscetibilidade a desgastes durante o uso da prótese. [005] Another inconvenience that must be considered is the fact that, as it is obtained by the extrusion process, both the dowels and the polyethylene plates do not reach an optimal degree of density, increasing their susceptibility to wear during use of the prosthesis.
Objetivos da Invenção Objectives of the Invention
[006] Com o objetivo de resolver os inconvenientes citados anteriormente, foi que se desenvolveu a presente invenção. Sendo proposto um processo para a fabricação do inserto acetabular, o qual compreende a injeção/prensagem de polietileno de ultra alto peso molecular (UHMW PE) - na forma granulada - no interior de um molde de injeção/molde de prensagem. Sendo que, o elemento do molde que dá forma à cavidade acetabular do inserto é realizado com altíssimo grau de polimento, obtendo-se no produto que foi formado através da elevada força de compressão (em Kgf/cm2) uma baixíssima rugosidade superficial. Este processo resulta num inserto acetabular cuja cavidade acetabular apresenta um grau de polimento excelente, reduzindo sensivelmente a possibilidade de atrito entre a prótese da cabeça femoral, e assim, reduzindo a possibilidade de desgastes entre as superfícies de contato, os pares tribológicos. A injeção em molde - que ocorre sob alta pressão e elevada temperatura - também confere ao produto final uma maior densidade, aumentando a sua rigidez, e principalmente, aumentando a dureza da superfície da cavidade acetabular interna, já que esta superfície original não é removida pelo processo de usinagem. E destacando também a vantagem de que, no presente processo é empregado apenas o material necessário à obtenção do inserto acetabular, proporcionando considerável economia de material e, portanto, trazendo vantagem econômica com um acabamento superficial muito superior. [006] In order to solve the drawbacks mentioned above, the present invention was developed. Being proposed a process for the manufacture of the acetabular insert, which comprises the injection/pressing of ultra high molecular weight polyethylene (UHMW PE) - in granular form - inside an injection mould/press mould. Since the element of the mold that shapes the acetabular cavity of the insert is made with a very high degree of polishing, obtaining a very low surface roughness in the product that was formed through the high compression force (in Kgf/cm2). This process results in an acetabular insert whose acetabular cavity presents an excellent degree of polishing, significantly reducing the possibility of friction between the femoral head prosthesis, and thus, reducing the possibility of wear between the contact surfaces, the tribological pairs. Mold injection - which occurs under high pressure and high temperature - also gives the final product greater density, increasing its rigidity, and mainly, increasing the hardness of the surface of the internal acetabular cavity, since this original surface is not removed by the machining process. And also highlighting the advantage that, in the present process, only the material necessary to obtain the acetabular insert is used, providing considerable material savings and, therefore, bringing economic advantage with a much superior surface finish.
Descrição dos desenhos Description of drawings
[007] Para melhor compreensão da presente Invenção, é feita em seguida uma descrição detalhada da mesma, fazendo-se referências aos desenhos anexos, onde a: [007] For a better understanding of the present invention, a detailed description of the same is given below, making reference to the attached drawings, where:
FIGURA 1 representa um Inserto Acetabular em corte central; FIGURE 1 represents an Acetabular Insert in central section;
FIGURA 2 representa em perspectiva a parte do Molde que possui o elemento de formação da superfície polida da cavidade do inserto acetabular; FIGURE 2 represents in perspective the part of the Mold that has the element for forming the polished surface of the acetabular insert cavity;
FIGURA 3 representa em vista lateral a parte do Molde que possui o elemento de formação da superfície polida da cavidade do inserto acetabular; e a FIGURA 4 representa em vista superior a parte do Molde que possui o elemento de formação da superfície polida da cavidade do inserto acetabular. FIGURE 3 represents in side view the part of the Mold that has the element for forming the polished surface of the acetabular insert cavity; and the FIGURE 4 represents in a top view the part of the Mold that has the element for forming the polished surface of the acetabular insert cavity.
Descrição detalhada da invenção Detailed description of the invention
[008] De acordo com estas ilustrações e em seus pormenores, a presente invenção: PROCESSO DE FABRICAÇÃO DE INSERTO ACETABULAR, compreende o emprego de um ferramental especial, em aço de alta dureza, na forma de um molde (M) de injeção para termoplástico, cujo elemento esférico (E) que dá a forma à cavidade côncava (K) do inserto acetabular (A) resultante, possui a sua superfície - convexa - realizada com altíssimo grau de polimento. Sendo que, o referido molde é acionado por uma prensa injetora hidráulica, a qual injeta o polietileno de ultra alto peso molecular (UHMW PE) na forma de pó à alta temperatura - portanto em estado de fusão - e à alta pressão, de modo que, a peça conformada - inserto acetabular (A) - resultante apresenta a superfície da cavidade acetabular (K) com altíssimo grau de polimento e livre de imperfeições, gerando assim uma superfície acabada e pronta para cumprir a sua finalidade final e, portanto, sem necessidade de qualquer interferência posterior para adequação; necessitando apenas de pequena usinagem na sua porção posterior, para adaptação ao receptáculo (não ilustrado) que faz a interface com o interior da cavidade acetabular original do osso ílio. [008] According to these illustrations and in their details, the present invention: MANUFACTURING PROCESS OF Acetabular Insert, comprises the use of a special tooling, in high hardness steel, in the form of an injection mold (M) for thermoplastic , whose spherical element (E) that shapes the concave cavity (K) of the resulting acetabular insert (A), has its surface - convex - made with a very high degree of polishing. This mold is driven by a hydraulic injection press, which injects the ultra high molecular weight polyethylene (UHMW PE) in powder form at high temperature - therefore in a state of fusion - and at high pressure, so that , the shaped part - acetabular insert (A) - presents the surface of the acetabular cavity (K) with a very high degree of polishing and free of imperfections, thus generating a finished surface ready to fulfill its final purpose and, therefore, without the need for from any further interference to suitability; only needing a little machining in its posterior portion, for adaptation to the receptacle (not illustrated) that makes the interface with the interior of the original acetabular cavity of the ilium bone.
[009] Logicamente, o presente PROCESSO DE FABRICAÇÃO DE INSERTO ACETABULAR pode apresentar variações na sua forma de realização; podendo-se empregar variedade de equipamentos, e também variedade de materiais, desde que sejam mantidas as características particulares básicas e que são essenciais à sua realização, principalmente o fato de que a superfície da cavidade (K) do inserto acetabular (A) resulta um produto acabado após o processo de injeção no molde. [009] Logically, the present ACETABULAR INSERT MANUFACTURING PROCESS may present variations in its embodiment; a variety of equipment can be used, as well as a variety of materials, as long as the particular basic characteristics are maintained and which are essential to its realization, mainly the fact that the surface of the cavity (K) of the acetabular insert (A) results in a finished product after injection molding process.

Claims

5 5
REIVINDICAÇÕES
1) PROCESSO DE FABRICAÇÃO DE INSERTO ACETABULAR, caracterizado por compreender o emprego de um ferramental especial, em aço de alta dureza, na forma de um molde (M) de injeção para termoplástico, cujo elemento esférico (E) que dá a forma à cavidade côncava (K) do inserto acetabular (A) resultante, possui a sua superfície - convexa - realizada com altíssimo grau de polimento; sendo que, o referido molde é acionado por uma prensa injetora hidráulica, a qual injeta o polietileno de ultra alto peso molecular (UHMW PE) na forma de pó à alta temperatura - portanto em estado de fusão - e à alta pressão, de modo que, a peça conformada - inserto acetabular (A) - resultante apresenta a superfície da cavidade acetabular (K) com altíssimo grau de polimento e livre de imperfeições, gerando assim uma superfície acabada e pronta para cumprir a sua finalidade final e, portanto, sem necessidade de qualquer interferência posterior para adequação; necessitando apenas de pequena usinagem na sua porção posterior, para adaptação ao receptáculo que faz a interface com o interior da cavidade acetabular original do osso ilíaco. 1) MANUFACTURING PROCESS OF ACETABULAR INSERTS, characterized by the use of a special tooling, in high hardness steel, in the form of an injection mold (M) for thermoplastic, whose spherical element (E) gives shape to the cavity concave (K) of the resulting acetabular insert (A), has its surface - convex - made with a very high degree of polishing; the aforementioned mold being driven by a hydraulic injection press, which injects the ultra high molecular weight polyethylene (UHMW PE) in powder form at high temperature - therefore in a state of fusion - and at high pressure, so that , the resulting shaped part - acetabular insert (A) - presents the surface of the acetabular cavity (K) with a very high degree of polishing and free of imperfections, thus generating a finished surface ready to fulfill its final purpose and, therefore, without the need for from any further interference to suitability; only needing a little machining in its posterior portion, for adaptation to the receptacle that makes the interface with the interior of the original acetabular cavity of the iliac bone.
PCT/BR2021/050564 2021-12-20 2021-12-20 Process of manufacturing an acetabular insert WO2023115172A1 (en)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050146070A1 (en) * 2002-06-21 2005-07-07 Massachusetts General Hospital Meta lback or mesh crosslinking
US20060198943A1 (en) * 2005-03-03 2006-09-07 Biomet Manufacturing Corp. Acetabular shell system and method for making
US20160220376A1 (en) * 2010-10-08 2016-08-04 Yadong Li Artificial acetabulum with multi-layer shell core composite structure
US9718241B2 (en) * 2008-01-30 2017-08-01 Zimmer, Inc. Method of manufacturing an acetabular component

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050146070A1 (en) * 2002-06-21 2005-07-07 Massachusetts General Hospital Meta lback or mesh crosslinking
US20060198943A1 (en) * 2005-03-03 2006-09-07 Biomet Manufacturing Corp. Acetabular shell system and method for making
US9718241B2 (en) * 2008-01-30 2017-08-01 Zimmer, Inc. Method of manufacturing an acetabular component
US20160220376A1 (en) * 2010-10-08 2016-08-04 Yadong Li Artificial acetabulum with multi-layer shell core composite structure

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