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KR-20260066658-A - Method for manufacturing a prosthetic implant and a prosthetic implant obtained thereby

KR20260066658AKR 20260066658 AKR20260066658 AKR 20260066658AKR-20260066658-A

Abstract

A method for manufacturing a prosthetic implant (10) comprises: - providing a first component (11) made of a first metal or metal alloy and having a first periphery (12); - providing a second component (13) made of a second metal or metal alloy and having a second periphery (14); - creating an assembly (15) formed by the first component (11) and the second component (13) by joining by interference fit of the first periphery (12) and the second periphery (14); and - inserting the assembly (15) into an isostatic forming machine (16) for a predetermined time until a diffusion bond between the first component and the second component is obtained by hot isostatic forming.

Inventors

  • 불폰, 미켈레
  • 프레사코, 미켈레

Assignees

  • 리마코포레이트 에스.피.에이.

Dates

Publication Date
20260512
Application Date
20240524
Priority Date
20230525

Claims (20)

  1. In a method for manufacturing a prosthetic implant, - A step of providing a first component (11) made of a first metal or metal alloy and having a first perimeter (12); - A step of providing a second component (13) made of a second metal or metal alloy and equipped with a second perimeter (14); - A step of creating an assembly (15) formed by the first component (11) and the second component (13) by the connection of the first perimeter (12) and the second perimeter (14) by interference fit; A method for manufacturing a prosthetic implant, characterized by including the step of inserting the assembly (15) into an isostatic molding machine (16) for a predetermined time until a diffusion bond between the first component and the second component is obtained by hot isostatic molding.
  2. A method for manufacturing a prosthetic implant according to claim 1, wherein the first component (11) comprises a concave seating portion (17) having a hemispherical or at least partially hemispherical shape, and the second component comprises a cap (21) having a hemispherical or at least partially hemispherical shape that substantially matches the shape of the concave seating portion (17).
  3. A method for manufacturing a prosthetic implant according to claim 2, wherein an interface (G) having a substantially hemispherical or at least partially hemispherical shape is formed between the concave seating portion (17) and the cap (21), and the diffusion bond is formed along this interface.
  4. A method for manufacturing a prosthetic implant according to claim 3, wherein the interface (G) defines the absence of direct close contact between the first component (11) and the second component (12).
  5. A method for manufacturing a prosthetic implant, characterized in that, in any one of claims 1 to 4, the connection by the interference fit occurs in the contact zone (Z) between the side walls (25, 26) of the periphery (12, 14).
  6. A method for manufacturing a prosthetic implant according to claim 5, wherein the contact zone (Z) is a substantially annular interference fit zone between the first circumference (12) and the second circumference (14).
  7. A method for manufacturing a prosthetic implant according to claim 5 or 6, wherein the contact zone (Z) is defined as a closed pore region between the first component (11) and the second component (13) that cannot access the inert gas provided within the isobaric molding machine (16).
  8. A method for manufacturing a prosthetic implant according to claim 7, wherein the connection by the interference fit between the first circumference portion (12) and the second circumference portion (14) is suitable for creating the closed pore between the first component (11) and the second component (13).
  9. A method for manufacturing a prosthetic implant according to claim 8, wherein the first metal or metal alloy and the second metal or metal alloy have different thermal expansions.
  10. A method for manufacturing a prosthetic implant according to claim 9, wherein the connection by the interference fit utilizes the difference in thermal expansion between two different metal materials of the first component (11) and the second component (13), which increases the force in the contact zone (Z) between the first periphery (12) and the second periphery (14) during the first thermal cycle phase when the assembly (15) is heated, and has a high holding force.
  11. A method for manufacturing a prosthetic implant, characterized in that, in any one of claims 7 to 10, the size of the section where the connection by the interference fit occurs between the first perimeter (12) and the second perimeter (14) is defined as a function of the pressure of the inert gas applied by the isostatic molding machine (16).
  12. A method for manufacturing a prosthetic implant, wherein, in any one of claims 7 to 11, the interference fit formed between the first periphery (12) and the second periphery (14) does not allow the inert gas to enter the interface (G) during the process in the isostatic molding machine (16), and allows a metallurgical bond to be obtained by diffusion bonding between the first component (11) and the second component (13) made of different metals or metal alloys.
  13. A method for manufacturing a prosthetic implant, wherein, in any one of claims 1 to 12, the first component (11) is made using a titanium-based alloy.
  14. A method for manufacturing a prosthetic implant, wherein, in any one of claims 1 to 13, the outer surface (19) of the first component (11) has a porous or trabecular structure.
  15. A method for manufacturing a prosthetic implant, wherein, in any one of claims 1 to 14, the second component (13) is made using a cobalt-based alloy.
  16. A method for manufacturing a prosthetic implant, characterized in that, in any one of claims 1 to 15, the first circumference portion (12) and the second circumference portion (14) are cylindrical.
  17. A method for manufacturing a prosthetic implant, characterized in that, in any one of claims 1 to 15, the first circumference (12) and the second circumference (14) are truncated cone-shaped.
  18. A method for manufacturing a prosthetic implant, characterized in that, in any one of claims 1 to 17, the first circumference portion (12) provides a seating portion (27) into which the second circumference portion (14), substantially conforming to a ring shape, is inserted.
  19. A method for manufacturing a prosthetic implant, characterized in that, in any one of claims 2 to 10, the surface roughness of the concave seating portion (17) and the cap (21) is about 1 μm Ra or less.
  20. A method for manufacturing a prosthetic implant, characterized in that, in any one of claims 1 to 19, the assembly (15) is discharged from the isostatic molding machine (16) and a subsequent final finishing step is provided.

Description

Method for manufacturing a prosthetic implant and a prosthetic implant obtained thereby The present invention relates to a method for manufacturing a prosthetic implant and a prosthetic implant obtained thereby. The prosthetic implant can be used, for example, to restore a hip joint or a shoulder joint. In the field of orthopedic prosthetics, for example in the case of the hip joint, it is known to manufacture an orthopedic or prosthetic implant having a hemispherical cavity that serves as a positioning and rotational seating area for the head of a femoral prosthesis. The femoral head may be made of polyethylene, polyether ether ketone (PPEK), ceramic material, or other materials. Prosthetic implants can be manufactured by two hemispherical metal components produced and joined using various methods, for example by diffusion welding known in the metallurgy sector as "diffusion joining." This technology consists of bonding two metal surfaces together through the action of temperature and pressure, and is completed by using a mechanical element or external device that comes into direct contact with the components to press the components together. Direct contact with external devices made of different materials can cause plastic deformation on the surface of the component to be bonded and having a certain pore size, cause morphological deformation of the network structure built and optimized to increase bone growth, and cause chemical contamination or the incorporation of foreign residues that can reduce the osteoconductivity of the porous surface. Therefore, known methods for manufacturing prosthetic implants by diffusion bonding require direct contact with an external mechanical device or means along at least one axis to apply appropriate pressure to them, and such procedures may result in defects or unwanted morphological and structural changes in the final orthopedic implant. Known methods are also limited by the geometric shape of the components to be bonded. For example, it is difficult for an external device to apply uniform pressure to a hemispherical surface, which is a typical shape of the components to be bonded. The disclosed devices and methods are also quite complex, and therefore, their implementations are often difficult in terms of cost and production time. International Publication WO 01/54561 A2 describes a prosthetic knee joint having an articular surface formed as a sintered polycrystalline diamond compact component. In particular, the sintered polycrystalline diamond compact component provides chemical bonding and mechanical gripping between the articular surface and the metal-containing, i.e., metallic substrate material. The polycrystalline diamond compact component can be used in the femoral head and/or acetabular cup. The polycrystalline diamond compact component provides chemical bonding between the metallic substrate material and the diamond crystals. A method for manufacturing the polycrystalline diamond compact component involves sintering diamond crystals together and on a metallic substrate under high pressure and high temperature. Generally, a certain amount of diamond raw material supplied as diamond powder or crystals is positioned adjacent to the metallic substrate before sintering. The interface between the diamond powder and the substrate material is a critical region where bonding of the diamond material to the metallic substrate must occur. When diamond powder or crystals are assembled with a metallic substrate, high pressure and high temperature are applied to the assembly to cause bonding between the diamond crystals and with the substrate. The resulting structure of the sintered polycrystalline diamond material bonded to the metallic substrate defines the aforementioned polycrystalline diamond compact component, that is, a composite structure of two materials of different properties, namely diamond crystals and a metallic substrate. The technology for feeding the raw material used for diamonds is critical to the success of the final product design. The diamond material must be fed at a uniform density to manufacture components free from unwanted distortion. To this end, a considerably complex device is provided that includes a rotary rod with an end suitable for the size and shape of the part to be manufactured. For example, if the part to be manufactured is a femoral head or an acetabular cup, the end of the rotary rod is hemispherical. A compression ring having a hole through which the rotary rod can protrude is provided. A die or mold is provided that has a cavity also adapted to the size and shape of the part to be manufactured. To feed the diamond material, the rotary rod is positioned within a drill chuck and aligned with the center point of the die or mold. A known amount of diamond material is fed into the mold. Then, the rotary rod is rotated around its longitudinal axis and lowered into the mold cavity to a predetermined depth. During this operation, the rota